Outstanding Service in Hospital Medicine

Efren Manjarrez, MD, SFHM, FACP, is an associate professor of clinical medicine at the University of Miami Miller School of Medicine, where he also serves as a hospitalist in the division of hospital medicine. His high-impact work at his home institution and through SHM has been extensive.

He founded the division of hospital medicine at the University of Miami in 2000 and later served as the division chief and patient safety officer. Dr. Manjarrez served in the prestigious role of course director for HM15 and as co-course director for the Adult Hospital Medicine Boot Camp.

One of his most enduring contributions is as an author of the white paper on hospitalist handoffs, published in the Journal of Hospital Medicine in 2009, which continues to be cited and validated. He was an assistant editor for the Journal of Hospital Medicine and continues to review articles for JHM. Dr. Manjarrez is also a senior fellow in hospital medicine.

Excellence in Research

Shoshana J. Herzig, MD, MPH, is the director of hospital medicine research at Beth Israel Deaconess Medical Center in Boston, where she also serves as a hospitalist. She is also an associate professor of medicine at Harvard Medical School, also in Boston.

She has published nearly 50 original peer-reviewed manuscripts in some of medicine’s top journals. Her impressive research, which primarily focuses on patterns of medication utilization and associated outcomes in hospitalized adults, has been cited more than 1,500 times in the medical literature.

In addition to her work on medication safety, she is also a site PI for the Hospital Medicine Research Network (HOMERuN), a nationwide collaborative of hospital medicine researchers.

Dr. Herzig has been a member of SHM since 2008 and has attended the annual conference every year since. She has served as an RIV abstract judge, was instrumental in developing SHM’s consensus statement on safe opioid prescribing, and has served as an editor for the Journal of Hospital Medicine since 2012 and has been a senior deputy editor since 2015.

Clinical Leadership for Physicians

Karen Smith, MD, MEd, SFHM, is the chief of the division of hospitalist medicine and past president of the medical staff at Children’s National Medical Center in Washington. She also serves as associate professor of pediatrics at the George Washington University School of Medicine. She has consistently worked to create a supportive environment in which to promote wellness among her staff and colleagues.

She was one of three founding faculty members of the division of hospital medicine at Children’s National, and under her leadership, the division has seen substantial growth. It has evolved from a single site to a comprehensive model of services, spanning six community hospitals and a specialty hospital for rehabilitation and subacute care.

To increase morale, Dr. Smith spearheaded the development of a virtual physician lounge. She reserved a conference room once a month and provided free lunch to medical staff members of different specialties. Its success led to the construction of a full-time lounge – all because of Dr. Smith’s perseverance and forward thinking.

She is a past member of SHM’s Pediatrics Committee and Hospital Quality and Patient Safety Committee and is a senior fellow in hospital medicine.

Excellence in Teaching

Kathleen M. Finn, MD, M.Phil, SFHM, is the senior associate program director for resident and faculty development in the Massachusetts General Hospital internal medicine residency program at Harvard Medical School, both in Boston, where she also is an assistant professor of medicine. She has excelled at teaching at all levels and in all kinds of settings, from clinical teaching on inpatient rounds, educating faculty through workshops to serving as course director for Hospital Medicine 2018 in Orlando. She constantly strives to think creatively and to teach in new ways and considers her career to be a synergy of all three domains in medical education: clinical teaching, leadership, and research.

Her interest in improving the art of inpatient teaching has also taken Dr. Finn into the medical education research space, where she has conducted and published several significant studies.

She was the codirector of the Boston chapter of SHM for 18 years and is well known for her dedication to SHM’s annual conference. She gained a reputation on the Annual Conference Committee for coming up with creative topics, including the Great Debate series.

Dr. Finn has previously served on the editorial board for the Journal of Hospital Medicine, where she continues to be a reviewer. She is a senior fellow in hospital medicine.

Excellence in Teaching

Juan Nicolás Lessing, MD, is an assistant professor of medicine within the division of hospital medicine at the Medical School at the University of Colorado at Denver, Aurora. He has dedicated himself to the teaching and study of clinical reasoning processes and has cocreated a resident clinical reasoning curriculum, which has been expended to all residency classes.

Dr. Lessing’s dedication to mentorship has been extraordinary. In fewer than 5 years, he has mentored more than 50 learners, resulting in 54 competitive abstracts, posters, and presentations. He has led more than 24 workshops and consistently sponsors junior colleagues to join him. In summary, he teaches learners how to learn rather than what to learn. Additionally, Dr. Lessing created and facilitated several impactful department-wide sessions on how we can learn from our mistakes to openly discuss missed diagnoses. He served as a co-PI on the LOOP study, a multicenter endeavor to provide real-time feedback to admitting residents on a patient’s clinical course, which was published in the Journal of Hospital Medicine.

Dr. Lessing has been actively involved with SHM since medical school, is a graduate of SHM’s Academic Hospitalist Academy, and serves on the executive board for the Rocky Mountain chapter of SHM.

Clinical Leadership for NPs/PAs

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucia, Fla., and also serves as the physician assistant department chair/program director at South University, where she supervises more than 40 PAs, medical directors, and administrative staff.

She continuously drives innovative projects for NPs and PAs to demonstrate excellence in collaboration by working closely with C-suite administration to expand QI (quality improvement) and education efforts. A prime example is the optimal communication system that she developed within her first week as a hospitalist in the Port St. Lucie area. Nursing, ED, and pharmacy staff had difficulty contacting hospitalists since the EMR would not reflect the assigned hospitalist, so she developed a simple contact sheet that included the hospitalist team each day. This method is still in use today.

Ms. Gadalla is the chair of SHM’s NP/PA special interest group who was integral in drafting the recent white paper on NP/PA integration and optimization.

Excellence in Humanitarian Services

Khaalisha Ajala, MD, MBA, is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She cares for patients of diverse backgrounds directly and also has a deep-seeded passion for public health and patient education, always demonstrating how to bring this passion to trainee education.

Using her knowledge as an MBA, Dr. Ajala has designed, developed, and now maintains her own nonprofit agency, Heart Beats & Hip-Hop. Through this organization, she has hosted public health fairs to conduct health screenings in less-traditional local settings, where community members who may not have access to care can gain exposure to a health care provider.

More broadly, in the last year, she has made two journeys – one to Thailand and another to Ethiopia – to work with Emory trainees in educational and clinical efforts to help them engage the global community in health improvement. In Thailand, she taught students how to care for patients at risk for trafficking and sexual exploitation. While in Ethiopia, she served as an educator and clinical preceptor to Emory residents in the global health pathway, teaching them to care for high-risk patients at a local hospital.

With her active and unrelenting humanitarian efforts in mind, she was also chosen as a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

Diversity Leadership

Kimberly D. Manning, MD, FACP, FAAP, is a professor of medicine and the associate vice chair of diversity, equity and inclusion at the Emory University School of Medicine in Atlanta, where she also is a hospitalist at Grady Memorial Hospital. She demonstrates a strong passion for building and strengthening diverse clinical learning environments. This inspired her to promote cultural competency via lectures, curriculum development, and more.

Dr. Manning has designed a new educational modality – Bite-Sized Teaching (abbreviated “BST” and read as “BEAST”-Mode Teaching). This engages trainees as the teachers of their peers. As part of those sessions, Dr. Manning intentionally encourages and engages trainees from all backgrounds, including women, minorities, and trainees with varied ethnic and cultural perspectives.

Her leadership on the Emory Task Force on Diversity, Equity and Inclusion led her to be named the department of medicine’s first associate vice chair of diversity, equity and inclusion. Due in large part to her engagement, the medical school just admitted its largest class of underrepresented minorities, nearly doubling numbers from prior years.

She has received the 2018 AGCME Parker J. Palmer Courage to Teach Award and the 2019 Lifetime Achievement Award by the Association of Black Women Physicians. 

Leadership for Practice Manager

Douglas G. Philpot, MHA, MBA, MHR, FACHE, currently the hospitalist program director at Intermountain Healthcare in Salt Lake City, epitomizes excellence in practice management.

In mid-2018, Intermountain Healthcare transitioned to a new organizational structure that brought all medical and surgical operations under one leadership team. Prior to this reorganization, hospitalist groups were largely divided by the geographies they served, each operating independently.

After the reorganization, it was apparent that staffing structures among groups varied greatly. Dr. Philpot pored over the workload and billing data and determined the most efficient use of how to staff hospitalist providers. He recently created a program that allows all stakeholders to meet and discuss in an unbiased manner how and when to add resources to a given group. As a result, the team is better able to make smart decisions that translate into improved quality, better patient experience, a more engaged hospitalist group and improved financial decisions. This is a model that Intermountain is now looking to apply to other specialties.

Team Award in Quality Improvement

The Michigan Hospital Medicine Safety Consortium has been in place for a decade and has worked together to improve quality and safety for patients across Michigan and the nation. It has been led since its inception by Scott Flanders, MD, a hospitalist at the University of Michigan, Ann Arbor.

At each participating hospital, teams include hospitalists, infectious disease clinicians, interventional radiologists, nephrologists, nurses, pharmacists, administrators, and more. This integration ensures that the team’s work is highly relevant and generalizable for hospitals around the country.

Their initiatives have informed regulatory and guideline writing authorities in the United States and beyond. For example, findings from their venous thromboembolism project demonstrated that the majority of hospitalized patients do not benefit from VTE prophylaxis, but rather, targeted strategies to define those at high risk. In 2016, their work helped to prevent 852 VTEs in Michigan alone. This led to changes in national guidelines that now emphasize deimplementing pharmacologic VTE prophylaxis and focused risk-assessment in U.S. hospitals.

Their antimicrobial use initiative has led to a robust partnership between hospitalists, hospitals, and national partners, such as the Centers for Disease Control and Prevention. Early work has informed a key gap in stewardship – discharge antibiotic prescribing – which has been a focus for SHM, the CDC, and many others. Efforts have already led to a reduction in thousands of unnecessary antibiotic prescriptions in Michigan.

Junior Investigator Award

SHM’s Research Committee presents the Junior Investigator Award to recognize early-career hospitalist researchers who are leading the way in their field. We are pleased to present the HM20 Junior Investigator Award to Valerie Vaughn, MD, MSc.

Dr. Vaughn is an assistant professor and research scientist in the division of hospital medicine at the University of Michigan and Veterans Affairs Ann Arbor Healthcare System.

Her research is focused on engaging hospitalists in antibiotic prescribing, especially at discharge. She is the hospitalist lead for an initiative to improve antibiotic prescribing in 46 hospitals across Michigan. She has already made a national contribution to the field – two manuscripts that have received high praise and have been cited by the Joint Commission and the CDC in their updated recommendations for antibiotic stewardship. She has a grant from the Gordon and Betty Moore Foundation to study the role of diagnostic error in antibiotic overuse and just received a K08 career development award from the Agency for Healthcare Research and Quality to study methods to improve antibiotic prescribing at hospital discharge.

One of Dr. Vaughn’s career goals is to advance hospital medicine through mentoring the next generation of hospitalists. In 2017, she authored a manuscript titled “Mentee Missteps” in JAMA, which has been viewed nearly 40,000 times since publication. She continues to give talks on this topic and mentors clinical hospitalists on research projects to improve quality and safety.

Dr. Vaughn has worked closely with SHM and represents the society at the CDC’s Healthcare Infection Control Practices Advisory Committee quarterly meetings.

Certificate of Leadership in Hospital Medicine

The Certificate of Leadership in Hospital Medicine (CLHM) cultivates leadership skills in the context of specific hospital medicine challenges. This designation informs employers – or potential employers – with confidence that a candidate is equipped and ready to lead teams and grow an organization.

Charmaine Lewis, MD, MPH, FHM, CLHM, is the quality director for New Hanover Hospitalists in Wilmington, N.C., a role she has held for 7 years. She is also clinical assistant professor, department of medicine, University of North Carolina School of Medicine, Chapel Hill, serving as a mentor for internal medicine, surgery, and obstetrics residents completing projects in quality improvement.

While sitting on the CHF and readmissions committees at her institution, Dr. Lewis was asked why patients with heart failure came back to the hospital. This question launched an in-depth search for real-time and accurate data on heart failure patients in her institution. She worked with the Heart Failure Steering Committee to develop a process to close care gaps and document compliance to the ACC/AHA Get with the Guidelines: Heart Failure recommendations. She facilitated order set revisions, smart-phrase documentation in EPIC, and scripted bedside interdisciplinary rounding to facilitate compliance prior to patient discharge. She also created an end-user friendly dashboard to report compliance with medical leaders, and eventually this project was selected by the department of medicine as their annual quality goal.  The project has led to the improvement of CHF GWTG Composite Bundle compliance from 76% to 93%, and compliance with use of aldosterone antagonists from 22% to 85%.

Outstanding Service in Hospital Medicine

Efren Manjarrez, MD, SFHM, FACP, is an associate professor of clinical medicine at the University of Miami Miller School of Medicine, where he also serves as a hospitalist in the division of hospital medicine. His high-impact work at his home institution and through SHM has been extensive.

He founded the division of hospital medicine at the University of Miami in 2000 and later served as the division chief and patient safety officer. Dr. Manjarrez served in the prestigious role of course director for HM15 and as co-course director for the Adult Hospital Medicine Boot Camp.

One of his most enduring contributions is as an author of the white paper on hospitalist handoffs, published in the Journal of Hospital Medicine in 2009, which continues to be cited and validated. He was an assistant editor for the Journal of Hospital Medicine and continues to review articles for JHM. Dr. Manjarrez is also a senior fellow in hospital medicine.

Excellence in Research

Shoshana J. Herzig, MD, MPH, is the director of hospital medicine research at Beth Israel Deaconess Medical Center in Boston, where she also serves as a hospitalist. She is also an associate professor of medicine at Harvard Medical School, also in Boston.

She has published nearly 50 original peer-reviewed manuscripts in some of medicine’s top journals. Her impressive research, which primarily focuses on patterns of medication utilization and associated outcomes in hospitalized adults, has been cited more than 1,500 times in the medical literature.

In addition to her work on medication safety, she is also a site PI for the Hospital Medicine Research Network (HOMERuN), a nationwide collaborative of hospital medicine researchers.

Dr. Herzig has been a member of SHM since 2008 and has attended the annual conference every year since. She has served as an RIV abstract judge, was instrumental in developing SHM’s consensus statement on safe opioid prescribing, and has served as an editor for the Journal of Hospital Medicine since 2012 and has been a senior deputy editor since 2015.

Clinical Leadership for Physicians

Karen Smith, MD, MEd, SFHM, is the chief of the division of hospitalist medicine and past president of the medical staff at Children’s National Medical Center in Washington. She also serves as associate professor of pediatrics at the George Washington University School of Medicine. She has consistently worked to create a supportive environment in which to promote wellness among her staff and colleagues.

She was one of three founding faculty members of the division of hospital medicine at Children’s National, and under her leadership, the division has seen substantial growth. It has evolved from a single site to a comprehensive model of services, spanning six community hospitals and a specialty hospital for rehabilitation and subacute care.

To increase morale, Dr. Smith spearheaded the development of a virtual physician lounge. She reserved a conference room once a month and provided free lunch to medical staff members of different specialties. Its success led to the construction of a full-time lounge – all because of Dr. Smith’s perseverance and forward thinking.

She is a past member of SHM’s Pediatrics Committee and Hospital Quality and Patient Safety Committee and is a senior fellow in hospital medicine.

Excellence in Teaching

Kathleen M. Finn, MD, M.Phil, SFHM, is the senior associate program director for resident and faculty development in the Massachusetts General Hospital internal medicine residency program at Harvard Medical School, both in Boston, where she also is an assistant professor of medicine. She has excelled at teaching at all levels and in all kinds of settings, from clinical teaching on inpatient rounds, educating faculty through workshops to serving as course director for Hospital Medicine 2018 in Orlando. She constantly strives to think creatively and to teach in new ways and considers her career to be a synergy of all three domains in medical education: clinical teaching, leadership, and research.

Her interest in improving the art of inpatient teaching has also taken Dr. Finn into the medical education research space, where she has conducted and published several significant studies.

She was the codirector of the Boston chapter of SHM for 18 years and is well known for her dedication to SHM’s annual conference. She gained a reputation on the Annual Conference Committee for coming up with creative topics, including the Great Debate series.

Dr. Finn has previously served on the editorial board for the Journal of Hospital Medicine, where she continues to be a reviewer. She is a senior fellow in hospital medicine.

Excellence in Teaching

Juan Nicolás Lessing, MD, is an assistant professor of medicine within the division of hospital medicine at the Medical School at the University of Colorado at Denver, Aurora. He has dedicated himself to the teaching and study of clinical reasoning processes and has cocreated a resident clinical reasoning curriculum, which has been expended to all residency classes.

Dr. Lessing’s dedication to mentorship has been extraordinary. In fewer than 5 years, he has mentored more than 50 learners, resulting in 54 competitive abstracts, posters, and presentations. He has led more than 24 workshops and consistently sponsors junior colleagues to join him. In summary, he teaches learners how to learn rather than what to learn. Additionally, Dr. Lessing created and facilitated several impactful department-wide sessions on how we can learn from our mistakes to openly discuss missed diagnoses. He served as a co-PI on the LOOP study, a multicenter endeavor to provide real-time feedback to admitting residents on a patient’s clinical course, which was published in the Journal of Hospital Medicine.

Dr. Lessing has been actively involved with SHM since medical school, is a graduate of SHM’s Academic Hospitalist Academy, and serves on the executive board for the Rocky Mountain chapter of SHM.

Clinical Leadership for NPs/PAs

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucia, Fla., and also serves as the physician assistant department chair/program director at South University, where she supervises more than 40 PAs, medical directors, and administrative staff.

She continuously drives innovative projects for NPs and PAs to demonstrate excellence in collaboration by working closely with C-suite administration to expand QI (quality improvement) and education efforts. A prime example is the optimal communication system that she developed within her first week as a hospitalist in the Port St. Lucie area. Nursing, ED, and pharmacy staff had difficulty contacting hospitalists since the EMR would not reflect the assigned hospitalist, so she developed a simple contact sheet that included the hospitalist team each day. This method is still in use today.

Ms. Gadalla is the chair of SHM’s NP/PA special interest group who was integral in drafting the recent white paper on NP/PA integration and optimization.

Excellence in Humanitarian Services

Khaalisha Ajala, MD, MBA, is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She cares for patients of diverse backgrounds directly and also has a deep-seeded passion for public health and patient education, always demonstrating how to bring this passion to trainee education.

Using her knowledge as an MBA, Dr. Ajala has designed, developed, and now maintains her own nonprofit agency, Heart Beats & Hip-Hop. Through this organization, she has hosted public health fairs to conduct health screenings in less-traditional local settings, where community members who may not have access to care can gain exposure to a health care provider.

More broadly, in the last year, she has made two journeys – one to Thailand and another to Ethiopia – to work with Emory trainees in educational and clinical efforts to help them engage the global community in health improvement. In Thailand, she taught students how to care for patients at risk for trafficking and sexual exploitation. While in Ethiopia, she served as an educator and clinical preceptor to Emory residents in the global health pathway, teaching them to care for high-risk patients at a local hospital.

With her active and unrelenting humanitarian efforts in mind, she was also chosen as a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

Diversity Leadership

Kimberly D. Manning, MD, FACP, FAAP, is a professor of medicine and the associate vice chair of diversity, equity and inclusion at the Emory University School of Medicine in Atlanta, where she also is a hospitalist at Grady Memorial Hospital. She demonstrates a strong passion for building and strengthening diverse clinical learning environments. This inspired her to promote cultural competency via lectures, curriculum development, and more.

Dr. Manning has designed a new educational modality – Bite-Sized Teaching (abbreviated “BST” and read as “BEAST”-Mode Teaching). This engages trainees as the teachers of their peers. As part of those sessions, Dr. Manning intentionally encourages and engages trainees from all backgrounds, including women, minorities, and trainees with varied ethnic and cultural perspectives.

Her leadership on the Emory Task Force on Diversity, Equity and Inclusion led her to be named the department of medicine’s first associate vice chair of diversity, equity and inclusion. Due in large part to her engagement, the medical school just admitted its largest class of underrepresented minorities, nearly doubling numbers from prior years.

She has received the 2018 AGCME Parker J. Palmer Courage to Teach Award and the 2019 Lifetime Achievement Award by the Association of Black Women Physicians. 

Leadership for Practice Manager

Douglas G. Philpot, MHA, MBA, MHR, FACHE, currently the hospitalist program director at Intermountain Healthcare in Salt Lake City, epitomizes excellence in practice management.

In mid-2018, Intermountain Healthcare transitioned to a new organizational structure that brought all medical and surgical operations under one leadership team. Prior to this reorganization, hospitalist groups were largely divided by the geographies they served, each operating independently.

After the reorganization, it was apparent that staffing structures among groups varied greatly. Dr. Philpot pored over the workload and billing data and determined the most efficient use of how to staff hospitalist providers. He recently created a program that allows all stakeholders to meet and discuss in an unbiased manner how and when to add resources to a given group. As a result, the team is better able to make smart decisions that translate into improved quality, better patient experience, a more engaged hospitalist group and improved financial decisions. This is a model that Intermountain is now looking to apply to other specialties.

Team Award in Quality Improvement

The Michigan Hospital Medicine Safety Consortium has been in place for a decade and has worked together to improve quality and safety for patients across Michigan and the nation. It has been led since its inception by Scott Flanders, MD, a hospitalist at the University of Michigan, Ann Arbor.

At each participating hospital, teams include hospitalists, infectious disease clinicians, interventional radiologists, nephrologists, nurses, pharmacists, administrators, and more. This integration ensures that the team’s work is highly relevant and generalizable for hospitals around the country.

Their initiatives have informed regulatory and guideline writing authorities in the United States and beyond. For example, findings from their venous thromboembolism project demonstrated that the majority of hospitalized patients do not benefit from VTE prophylaxis, but rather, targeted strategies to define those at high risk. In 2016, their work helped to prevent 852 VTEs in Michigan alone. This led to changes in national guidelines that now emphasize deimplementing pharmacologic VTE prophylaxis and focused risk-assessment in U.S. hospitals.

Their antimicrobial use initiative has led to a robust partnership between hospitalists, hospitals, and national partners, such as the Centers for Disease Control and Prevention. Early work has informed a key gap in stewardship – discharge antibiotic prescribing – which has been a focus for SHM, the CDC, and many others. Efforts have already led to a reduction in thousands of unnecessary antibiotic prescriptions in Michigan.

Junior Investigator Award

SHM’s Research Committee presents the Junior Investigator Award to recognize early-career hospitalist researchers who are leading the way in their field. We are pleased to present the HM20 Junior Investigator Award to Valerie Vaughn, MD, MSc.

Dr. Vaughn is an assistant professor and research scientist in the division of hospital medicine at the University of Michigan and Veterans Affairs Ann Arbor Healthcare System.

Her research is focused on engaging hospitalists in antibiotic prescribing, especially at discharge. She is the hospitalist lead for an initiative to improve antibiotic prescribing in 46 hospitals across Michigan. She has already made a national contribution to the field – two manuscripts that have received high praise and have been cited by the Joint Commission and the CDC in their updated recommendations for antibiotic stewardship. She has a grant from the Gordon and Betty Moore Foundation to study the role of diagnostic error in antibiotic overuse and just received a K08 career development award from the Agency for Healthcare Research and Quality to study methods to improve antibiotic prescribing at hospital discharge.

One of Dr. Vaughn’s career goals is to advance hospital medicine through mentoring the next generation of hospitalists. In 2017, she authored a manuscript titled “Mentee Missteps” in JAMA, which has been viewed nearly 40,000 times since publication. She continues to give talks on this topic and mentors clinical hospitalists on research projects to improve quality and safety.

Dr. Vaughn has worked closely with SHM and represents the society at the CDC’s Healthcare Infection Control Practices Advisory Committee quarterly meetings.

Certificate of Leadership in Hospital Medicine

The Certificate of Leadership in Hospital Medicine (CLHM) cultivates leadership skills in the context of specific hospital medicine challenges. This designation informs employers – or potential employers – with confidence that a candidate is equipped and ready to lead teams and grow an organization.

Charmaine Lewis, MD, MPH, FHM, CLHM, is the quality director for New Hanover Hospitalists in Wilmington, N.C., a role she has held for 7 years. She is also clinical assistant professor, department of medicine, University of North Carolina School of Medicine, Chapel Hill, serving as a mentor for internal medicine, surgery, and obstetrics residents completing projects in quality improvement.

While sitting on the CHF and readmissions committees at her institution, Dr. Lewis was asked why patients with heart failure came back to the hospital. This question launched an in-depth search for real-time and accurate data on heart failure patients in her institution. She worked with the Heart Failure Steering Committee to develop a process to close care gaps and document compliance to the ACC/AHA Get with the Guidelines: Heart Failure recommendations. She facilitated order set revisions, smart-phrase documentation in EPIC, and scripted bedside interdisciplinary rounding to facilitate compliance prior to patient discharge. She also created an end-user friendly dashboard to report compliance with medical leaders, and eventually this project was selected by the department of medicine as their annual quality goal.  The project has led to the improvement of CHF GWTG Composite Bundle compliance from 76% to 93%, and compliance with use of aldosterone antagonists from 22% to 85%.

Outstanding Service in Hospital Medicine

Efren Manjarrez, MD, SFHM, FACP, is an associate professor of clinical medicine at the University of Miami Miller School of Medicine, where he also serves as a hospitalist in the division of hospital medicine. His high-impact work at his home institution and through SHM has been extensive.

He founded the division of hospital medicine at the University of Miami in 2000 and later served as the division chief and patient safety officer. Dr. Manjarrez served in the prestigious role of course director for HM15 and as co-course director for the Adult Hospital Medicine Boot Camp.

One of his most enduring contributions is as an author of the white paper on hospitalist handoffs, published in the Journal of Hospital Medicine in 2009, which continues to be cited and validated. He was an assistant editor for the Journal of Hospital Medicine and continues to review articles for JHM. Dr. Manjarrez is also a senior fellow in hospital medicine.

Excellence in Research

Shoshana J. Herzig, MD, MPH, is the director of hospital medicine research at Beth Israel Deaconess Medical Center in Boston, where she also serves as a hospitalist. She is also an associate professor of medicine at Harvard Medical School, also in Boston.

She has published nearly 50 original peer-reviewed manuscripts in some of medicine’s top journals. Her impressive research, which primarily focuses on patterns of medication utilization and associated outcomes in hospitalized adults, has been cited more than 1,500 times in the medical literature.

In addition to her work on medication safety, she is also a site PI for the Hospital Medicine Research Network (HOMERuN), a nationwide collaborative of hospital medicine researchers.

Dr. Herzig has been a member of SHM since 2008 and has attended the annual conference every year since. She has served as an RIV abstract judge, was instrumental in developing SHM’s consensus statement on safe opioid prescribing, and has served as an editor for the Journal of Hospital Medicine since 2012 and has been a senior deputy editor since 2015.

Clinical Leadership for Physicians

Karen Smith, MD, MEd, SFHM, is the chief of the division of hospitalist medicine and past president of the medical staff at Children’s National Medical Center in Washington. She also serves as associate professor of pediatrics at the George Washington University School of Medicine. She has consistently worked to create a supportive environment in which to promote wellness among her staff and colleagues.

She was one of three founding faculty members of the division of hospital medicine at Children’s National, and under her leadership, the division has seen substantial growth. It has evolved from a single site to a comprehensive model of services, spanning six community hospitals and a specialty hospital for rehabilitation and subacute care.

To increase morale, Dr. Smith spearheaded the development of a virtual physician lounge. She reserved a conference room once a month and provided free lunch to medical staff members of different specialties. Its success led to the construction of a full-time lounge – all because of Dr. Smith’s perseverance and forward thinking.

She is a past member of SHM’s Pediatrics Committee and Hospital Quality and Patient Safety Committee and is a senior fellow in hospital medicine.

Excellence in Teaching

Kathleen M. Finn, MD, M.Phil, SFHM, is the senior associate program director for resident and faculty development in the Massachusetts General Hospital internal medicine residency program at Harvard Medical School, both in Boston, where she also is an assistant professor of medicine. She has excelled at teaching at all levels and in all kinds of settings, from clinical teaching on inpatient rounds, educating faculty through workshops to serving as course director for Hospital Medicine 2018 in Orlando. She constantly strives to think creatively and to teach in new ways and considers her career to be a synergy of all three domains in medical education: clinical teaching, leadership, and research.

Her interest in improving the art of inpatient teaching has also taken Dr. Finn into the medical education research space, where she has conducted and published several significant studies.

She was the codirector of the Boston chapter of SHM for 18 years and is well known for her dedication to SHM’s annual conference. She gained a reputation on the Annual Conference Committee for coming up with creative topics, including the Great Debate series.

Dr. Finn has previously served on the editorial board for the Journal of Hospital Medicine, where she continues to be a reviewer. She is a senior fellow in hospital medicine.

Excellence in Teaching

Juan Nicolás Lessing, MD, is an assistant professor of medicine within the division of hospital medicine at the Medical School at the University of Colorado at Denver, Aurora. He has dedicated himself to the teaching and study of clinical reasoning processes and has cocreated a resident clinical reasoning curriculum, which has been expended to all residency classes.

Dr. Lessing’s dedication to mentorship has been extraordinary. In fewer than 5 years, he has mentored more than 50 learners, resulting in 54 competitive abstracts, posters, and presentations. He has led more than 24 workshops and consistently sponsors junior colleagues to join him. In summary, he teaches learners how to learn rather than what to learn. Additionally, Dr. Lessing created and facilitated several impactful department-wide sessions on how we can learn from our mistakes to openly discuss missed diagnoses. He served as a co-PI on the LOOP study, a multicenter endeavor to provide real-time feedback to admitting residents on a patient’s clinical course, which was published in the Journal of Hospital Medicine.

Dr. Lessing has been actively involved with SHM since medical school, is a graduate of SHM’s Academic Hospitalist Academy, and serves on the executive board for the Rocky Mountain chapter of SHM.

Clinical Leadership for NPs/PAs

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucia, Fla., and also serves as the physician assistant department chair/program director at South University, where she supervises more than 40 PAs, medical directors, and administrative staff.

She continuously drives innovative projects for NPs and PAs to demonstrate excellence in collaboration by working closely with C-suite administration to expand QI (quality improvement) and education efforts. A prime example is the optimal communication system that she developed within her first week as a hospitalist in the Port St. Lucie area. Nursing, ED, and pharmacy staff had difficulty contacting hospitalists since the EMR would not reflect the assigned hospitalist, so she developed a simple contact sheet that included the hospitalist team each day. This method is still in use today.

Ms. Gadalla is the chair of SHM’s NP/PA special interest group who was integral in drafting the recent white paper on NP/PA integration and optimization.

Excellence in Humanitarian Services

Khaalisha Ajala, MD, MBA, is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She cares for patients of diverse backgrounds directly and also has a deep-seeded passion for public health and patient education, always demonstrating how to bring this passion to trainee education.

Using her knowledge as an MBA, Dr. Ajala has designed, developed, and now maintains her own nonprofit agency, Heart Beats & Hip-Hop. Through this organization, she has hosted public health fairs to conduct health screenings in less-traditional local settings, where community members who may not have access to care can gain exposure to a health care provider.

More broadly, in the last year, she has made two journeys – one to Thailand and another to Ethiopia – to work with Emory trainees in educational and clinical efforts to help them engage the global community in health improvement. In Thailand, she taught students how to care for patients at risk for trafficking and sexual exploitation. While in Ethiopia, she served as an educator and clinical preceptor to Emory residents in the global health pathway, teaching them to care for high-risk patients at a local hospital.

With her active and unrelenting humanitarian efforts in mind, she was also chosen as a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

Diversity Leadership

Kimberly D. Manning, MD, FACP, FAAP, is a professor of medicine and the associate vice chair of diversity, equity and inclusion at the Emory University School of Medicine in Atlanta, where she also is a hospitalist at Grady Memorial Hospital. She demonstrates a strong passion for building and strengthening diverse clinical learning environments. This inspired her to promote cultural competency via lectures, curriculum development, and more.

Dr. Manning has designed a new educational modality – Bite-Sized Teaching (abbreviated “BST” and read as “BEAST”-Mode Teaching). This engages trainees as the teachers of their peers. As part of those sessions, Dr. Manning intentionally encourages and engages trainees from all backgrounds, including women, minorities, and trainees with varied ethnic and cultural perspectives.

Her leadership on the Emory Task Force on Diversity, Equity and Inclusion led her to be named the department of medicine’s first associate vice chair of diversity, equity and inclusion. Due in large part to her engagement, the medical school just admitted its largest class of underrepresented minorities, nearly doubling numbers from prior years.

She has received the 2018 AGCME Parker J. Palmer Courage to Teach Award and the 2019 Lifetime Achievement Award by the Association of Black Women Physicians. 

Leadership for Practice Manager

Douglas G. Philpot, MHA, MBA, MHR, FACHE, currently the hospitalist program director at Intermountain Healthcare in Salt Lake City, epitomizes excellence in practice management.

In mid-2018, Intermountain Healthcare transitioned to a new organizational structure that brought all medical and surgical operations under one leadership team. Prior to this reorganization, hospitalist groups were largely divided by the geographies they served, each operating independently.

After the reorganization, it was apparent that staffing structures among groups varied greatly. Dr. Philpot pored over the workload and billing data and determined the most efficient use of how to staff hospitalist providers. He recently created a program that allows all stakeholders to meet and discuss in an unbiased manner how and when to add resources to a given group. As a result, the team is better able to make smart decisions that translate into improved quality, better patient experience, a more engaged hospitalist group and improved financial decisions. This is a model that Intermountain is now looking to apply to other specialties.

Team Award in Quality Improvement

The Michigan Hospital Medicine Safety Consortium has been in place for a decade and has worked together to improve quality and safety for patients across Michigan and the nation. It has been led since its inception by Scott Flanders, MD, a hospitalist at the University of Michigan, Ann Arbor.

At each participating hospital, teams include hospitalists, infectious disease clinicians, interventional radiologists, nephrologists, nurses, pharmacists, administrators, and more. This integration ensures that the team’s work is highly relevant and generalizable for hospitals around the country.

Their initiatives have informed regulatory and guideline writing authorities in the United States and beyond. For example, findings from their venous thromboembolism project demonstrated that the majority of hospitalized patients do not benefit from VTE prophylaxis, but rather, targeted strategies to define those at high risk. In 2016, their work helped to prevent 852 VTEs in Michigan alone. This led to changes in national guidelines that now emphasize deimplementing pharmacologic VTE prophylaxis and focused risk-assessment in U.S. hospitals.

Their antimicrobial use initiative has led to a robust partnership between hospitalists, hospitals, and national partners, such as the Centers for Disease Control and Prevention. Early work has informed a key gap in stewardship – discharge antibiotic prescribing – which has been a focus for SHM, the CDC, and many others. Efforts have already led to a reduction in thousands of unnecessary antibiotic prescriptions in Michigan.

Junior Investigator Award

SHM’s Research Committee presents the Junior Investigator Award to recognize early-career hospitalist researchers who are leading the way in their field. We are pleased to present the HM20 Junior Investigator Award to Valerie Vaughn, MD, MSc.

Dr. Vaughn is an assistant professor and research scientist in the division of hospital medicine at the University of Michigan and Veterans Affairs Ann Arbor Healthcare System.

Her research is focused on engaging hospitalists in antibiotic prescribing, especially at discharge. She is the hospitalist lead for an initiative to improve antibiotic prescribing in 46 hospitals across Michigan. She has already made a national contribution to the field – two manuscripts that have received high praise and have been cited by the Joint Commission and the CDC in their updated recommendations for antibiotic stewardship. She has a grant from the Gordon and Betty Moore Foundation to study the role of diagnostic error in antibiotic overuse and just received a K08 career development award from the Agency for Healthcare Research and Quality to study methods to improve antibiotic prescribing at hospital discharge.

One of Dr. Vaughn’s career goals is to advance hospital medicine through mentoring the next generation of hospitalists. In 2017, she authored a manuscript titled “Mentee Missteps” in JAMA, which has been viewed nearly 40,000 times since publication. She continues to give talks on this topic and mentors clinical hospitalists on research projects to improve quality and safety.

Dr. Vaughn has worked closely with SHM and represents the society at the CDC’s Healthcare Infection Control Practices Advisory Committee quarterly meetings.

Certificate of Leadership in Hospital Medicine

The Certificate of Leadership in Hospital Medicine (CLHM) cultivates leadership skills in the context of specific hospital medicine challenges. This designation informs employers – or potential employers – with confidence that a candidate is equipped and ready to lead teams and grow an organization.

Charmaine Lewis, MD, MPH, FHM, CLHM, is the quality director for New Hanover Hospitalists in Wilmington, N.C., a role she has held for 7 years. She is also clinical assistant professor, department of medicine, University of North Carolina School of Medicine, Chapel Hill, serving as a mentor for internal medicine, surgery, and obstetrics residents completing projects in quality improvement.

While sitting on the CHF and readmissions committees at her institution, Dr. Lewis was asked why patients with heart failure came back to the hospital. This question launched an in-depth search for real-time and accurate data on heart failure patients in her institution. She worked with the Heart Failure Steering Committee to develop a process to close care gaps and document compliance to the ACC/AHA Get with the Guidelines: Heart Failure recommendations. She facilitated order set revisions, smart-phrase documentation in EPIC, and scripted bedside interdisciplinary rounding to facilitate compliance prior to patient discharge. She also created an end-user friendly dashboard to report compliance with medical leaders, and eventually this project was selected by the department of medicine as their annual quality goal.  The project has led to the improvement of CHF GWTG Composite Bundle compliance from 76% to 93%, and compliance with use of aldosterone antagonists from 22% to 85%.

The COVID-19 pandemic continues to pose an unprecedented challenge to health care systems worldwide. In addition to the direct impact of the disease itself, there is a growing concern related to ensuring adequate health care utilization and addressing the needs of vulnerable populations, such as those with chronic illness.

Emanuel et al. have advocated a framework of fair allocation of resources, led by the principles of equity, maximizing benefits, and prioritizing the vulnerable. In these uncertain times, patients with rheumatic diseases represent a vulnerable population whose health and wellness are particularly threatened, not only by the risk of COVID-19, but also by reduced access to usual medical care (e.g., in-person clinic visits), potential treatment interruptions (e.g., planned infusion therapies), and the ongoing shortage of hydroxychloroquine, to name a few.

As rheumatologists, we are now tasked with the development of best practices for caring for patients with rheumatic conditions in this uncertain, evolving, and nearly data-free landscape. We also must maintain an active role as advocates for our patients to help them navigate this pandemic. Herein, we discuss our approach to caring for patients with rheumatic diseases within our practice in New York City, an epicenter of the COVID-19 pandemic.

Communication with patients

Maintaining an open line of communication with our patients (by phone, patient portal, telemedicine, and so on) has become more essential than ever. It is through these communications that we best understand our patients’ concerns and provide support and personalized treatment decisions. The most common questions we have received during recent weeks are:

• Should I stop my medication to lower my risk for infection?
• Are my current symptoms caused by coronavirus, and what should I do next?
• Where can I fill my hydroxychloroquine prescription?

The American College of Rheumatology has deployed a number of task forces aimed at advocating for rheumatologists and patients with rheumatic diseases and is doing an exemplary job guiding us. For patients, several other organizations (e.g., CreakyJoints, Arthritis Foundation, Lupus Research Alliance, Vasculitis Foundation, and Scleroderma Foundation) are also providing accurate information regarding hygiene practices, social distancing, management of medications, and other guidance related to specific rheumatic diseases. In line with ACR recommendations, we encourage a personalized, shared decision-making process with each of our patients.

Patients with rheumatic disease at risk for COVID-19 infection

First, for rheumatology patients who have no COVID-19 symptoms, our management approach is individualized. For patients who are able to maintain social distancing, we have not routinely stopped immunosuppressive medications, including disease-modifying antirheumatic drugs (DMARDs) and biologic agents. However, we discuss the risks and benefits of continuing immunosuppressive therapy during this time with all of our patients.

In certain cases of stable, non–life-threatening disease, we may consider spacing or temporarily interrupting immunosuppressive therapy, using individualized, shared decision making. Yet, it is important to recognize that, for some patients, achieving adequate disease control can require a substantial amount of time.

Furthermore, it is important to acknowledge that disease flares requiring steroid therapy may increase the risk for infection even more, keeping in mind that, in some rheumatic diseases, high disease activity itself can increase infection risk. We advise patients who are continuing therapy to maintain at least a 1-month supply of their medications.

Decisions regarding infusions in the hospital and outpatient settings are similarly made on an individual basis, weighing the risk for virus exposure against that of disease flare. The more limited availability of appropriately distanced infusion chairs in some already overburdened systems must be considered in this discussion. We agree with the ACR, whose infusion guidance recommends that “possible changes might include temporary interruption of therapy, temporary initiation of a bridge therapy such as a less potent anti-inflammatory or immune-modulating agent, or temporary change to an alternative therapy.”

We also reinforce recommended behaviors for preventing infection, including social distancing, frequent handwashing, and avoiding touching one’s face.

Patients with rheumatic disease and confirmed or suspected COVID-19 infection

With the worldwide spread of COVID-19, patients with rheumatic diseases will undoubtedly be among those exposed and infected. Though current data are limited, within a cohort from China, 1% had an autoimmune disease. Testing recommendations to confirm COVID-19 and decision guidelines for outpatient versus inpatient management are evolving, and we consult the most up-to-date, local information regarding testing as individual potential cases arise.

For patients who develop COVID-19 and are currently taking DMARDs and biologics, we recommend that they discontinue these medications, with the exception of hydroxychloroquine (HCQ). HCQ may be continued because its mechanism is not expected to worsen infection, and it plays a key role in the management of patients with systemic lupus erythematosus (SLE). In addition, in vitro antiviral effects have been reported and there is growing interest for its use in the management of COVID-19. However, there are conflicting data and methodological concerns about the nonrandomized human studies that suggest a benefit of HCQ against COVID-19.

The decision regarding management of glucocorticoids in the setting of new COVID-19 infection is challenging and should be individualized. At present, expert panels recommend against the use of glucocorticoids among individuals with COVID-19 who do not have acute respiratory distress syndrome. However, adrenal insufficiency must be considered among patients with COVID-19 who are treated with chronic glucocorticoids. Again, these decisions should be made on an individual, case-by-case basis.

Implications of a hydroxychloroquine shortage

The use of HCQ in rheumatology is supported by years of research. Particularly in SLE, HCQ has been shown to reduce disease activity and damage and to improve survival. Furthermore, for pregnant patients with SLE, numerous studies have demonstrated the safety and benefit of HCQ for both the mother and fetus; thus, it is strongly recommended. By contrast, despite the growing interest for HCQ in patients with COVID-19, the evidence is inconclusive and limited.

The ACR suggests that decisions regarding HCQ dose reductions to extend individual patients supplies should be tailored to each patient’s need and risk in the unfortunate setting of medication shortages. Even in patients with stable SLE, however, disease flares at 6 months are more common among individuals who discontinue HCQ. Of note, these flares may incorporate novel and severe disease manifestations.

Unfortunately, other therapeutic options for SLE are associated with more adverse effects (including increased susceptibility to infection) or are largely unavailable (e.g., quinacrine). Thus, we strive to continue standard dosing of HCQ for patients who are currently flaring or recently flared, and we make shared, individualized decisions for those patients with stable disease as the HCQ shortage evolves.

Future research on COVID-19 and rheumatic disease

While we might expect that an underlying rheumatic disease and associated treatments may predispose individuals to developing COVID-19, current data do not indicate which, if any, rheumatic diseases and associated therapies convey the greatest risk.

To address this uncertainty, the rheumatology community created the COVID-19 Global Rheumatology Alliance, an international effort to initiate and maintain a deidentified patient registry for individuals with rheumatic disease who develop COVID-19. These efforts will allow us to gain essential insights regarding which patient demographics, underlying diseases, and medications are most common among patients who develop COVID-19.

This alliance encourages rheumatologists and those caring for patients with rheumatic diseases to report their patient cases to this registry. As we are confronted with making management decisions with a scarcity of supporting data, efforts like these will improve our ability to make individualized treatment recommendations.

The COVID-19 pandemic has presented us all with unprecedented challenges. As rheumatologists, it is our duty to lead our patients through this uncharted territory with close communication, information, advocacy, and personalized treatment decisions. Each of these is central to the management of rheumatology patients during the COVID-19 pandemic.

With the growing interest in immunomodulatory therapies for the complications of this infection, we have the unique opportunity to share our expertise, recommendations, and caution with our colleagues. As clinicians and scientists, we must advocate for data collection and studies that will allow us to develop novel, data-driven disease management approaches while providing the best care possible for our patients.

Stephen Paget, MD, is physician in chief emeritus for the Center for Rheumatology at Hospital for Special Surgery in New York. Kimberly Showalter, MD, is a third-year rheumatology fellow at Hospital for Special Surgery. Sebastian E. Sattui, MD, is a third-year rheumatology and 1-year vasculitis fellow at Hospital for Special Surgery.

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

The COVID-19 pandemic continues to pose an unprecedented challenge to health care systems worldwide. In addition to the direct impact of the disease itself, there is a growing concern related to ensuring adequate health care utilization and addressing the needs of vulnerable populations, such as those with chronic illness.

Emanuel et al. have advocated a framework of fair allocation of resources, led by the principles of equity, maximizing benefits, and prioritizing the vulnerable. In these uncertain times, patients with rheumatic diseases represent a vulnerable population whose health and wellness are particularly threatened, not only by the risk of COVID-19, but also by reduced access to usual medical care (e.g., in-person clinic visits), potential treatment interruptions (e.g., planned infusion therapies), and the ongoing shortage of hydroxychloroquine, to name a few.

As rheumatologists, we are now tasked with the development of best practices for caring for patients with rheumatic conditions in this uncertain, evolving, and nearly data-free landscape. We also must maintain an active role as advocates for our patients to help them navigate this pandemic. Herein, we discuss our approach to caring for patients with rheumatic diseases within our practice in New York City, an epicenter of the COVID-19 pandemic.

Communication with patients

Maintaining an open line of communication with our patients (by phone, patient portal, telemedicine, and so on) has become more essential than ever. It is through these communications that we best understand our patients’ concerns and provide support and personalized treatment decisions. The most common questions we have received during recent weeks are:

• Should I stop my medication to lower my risk for infection?
• Are my current symptoms caused by coronavirus, and what should I do next?
• Where can I fill my hydroxychloroquine prescription?

The American College of Rheumatology has deployed a number of task forces aimed at advocating for rheumatologists and patients with rheumatic diseases and is doing an exemplary job guiding us. For patients, several other organizations (e.g., CreakyJoints, Arthritis Foundation, Lupus Research Alliance, Vasculitis Foundation, and Scleroderma Foundation) are also providing accurate information regarding hygiene practices, social distancing, management of medications, and other guidance related to specific rheumatic diseases. In line with ACR recommendations, we encourage a personalized, shared decision-making process with each of our patients.

Patients with rheumatic disease at risk for COVID-19 infection

First, for rheumatology patients who have no COVID-19 symptoms, our management approach is individualized. For patients who are able to maintain social distancing, we have not routinely stopped immunosuppressive medications, including disease-modifying antirheumatic drugs (DMARDs) and biologic agents. However, we discuss the risks and benefits of continuing immunosuppressive therapy during this time with all of our patients.

In certain cases of stable, non–life-threatening disease, we may consider spacing or temporarily interrupting immunosuppressive therapy, using individualized, shared decision making. Yet, it is important to recognize that, for some patients, achieving adequate disease control can require a substantial amount of time.

Furthermore, it is important to acknowledge that disease flares requiring steroid therapy may increase the risk for infection even more, keeping in mind that, in some rheumatic diseases, high disease activity itself can increase infection risk. We advise patients who are continuing therapy to maintain at least a 1-month supply of their medications.

Decisions regarding infusions in the hospital and outpatient settings are similarly made on an individual basis, weighing the risk for virus exposure against that of disease flare. The more limited availability of appropriately distanced infusion chairs in some already overburdened systems must be considered in this discussion. We agree with the ACR, whose infusion guidance recommends that “possible changes might include temporary interruption of therapy, temporary initiation of a bridge therapy such as a less potent anti-inflammatory or immune-modulating agent, or temporary change to an alternative therapy.”

We also reinforce recommended behaviors for preventing infection, including social distancing, frequent handwashing, and avoiding touching one’s face.

Patients with rheumatic disease and confirmed or suspected COVID-19 infection

With the worldwide spread of COVID-19, patients with rheumatic diseases will undoubtedly be among those exposed and infected. Though current data are limited, within a cohort from China, 1% had an autoimmune disease. Testing recommendations to confirm COVID-19 and decision guidelines for outpatient versus inpatient management are evolving, and we consult the most up-to-date, local information regarding testing as individual potential cases arise.

For patients who develop COVID-19 and are currently taking DMARDs and biologics, we recommend that they discontinue these medications, with the exception of hydroxychloroquine (HCQ). HCQ may be continued because its mechanism is not expected to worsen infection, and it plays a key role in the management of patients with systemic lupus erythematosus (SLE). In addition, in vitro antiviral effects have been reported and there is growing interest for its use in the management of COVID-19. However, there are conflicting data and methodological concerns about the nonrandomized human studies that suggest a benefit of HCQ against COVID-19.

The decision regarding management of glucocorticoids in the setting of new COVID-19 infection is challenging and should be individualized. At present, expert panels recommend against the use of glucocorticoids among individuals with COVID-19 who do not have acute respiratory distress syndrome. However, adrenal insufficiency must be considered among patients with COVID-19 who are treated with chronic glucocorticoids. Again, these decisions should be made on an individual, case-by-case basis.

Implications of a hydroxychloroquine shortage

The use of HCQ in rheumatology is supported by years of research. Particularly in SLE, HCQ has been shown to reduce disease activity and damage and to improve survival. Furthermore, for pregnant patients with SLE, numerous studies have demonstrated the safety and benefit of HCQ for both the mother and fetus; thus, it is strongly recommended. By contrast, despite the growing interest for HCQ in patients with COVID-19, the evidence is inconclusive and limited.

The ACR suggests that decisions regarding HCQ dose reductions to extend individual patients supplies should be tailored to each patient’s need and risk in the unfortunate setting of medication shortages. Even in patients with stable SLE, however, disease flares at 6 months are more common among individuals who discontinue HCQ. Of note, these flares may incorporate novel and severe disease manifestations.

Unfortunately, other therapeutic options for SLE are associated with more adverse effects (including increased susceptibility to infection) or are largely unavailable (e.g., quinacrine). Thus, we strive to continue standard dosing of HCQ for patients who are currently flaring or recently flared, and we make shared, individualized decisions for those patients with stable disease as the HCQ shortage evolves.

Future research on COVID-19 and rheumatic disease

While we might expect that an underlying rheumatic disease and associated treatments may predispose individuals to developing COVID-19, current data do not indicate which, if any, rheumatic diseases and associated therapies convey the greatest risk.

To address this uncertainty, the rheumatology community created the COVID-19 Global Rheumatology Alliance, an international effort to initiate and maintain a deidentified patient registry for individuals with rheumatic disease who develop COVID-19. These efforts will allow us to gain essential insights regarding which patient demographics, underlying diseases, and medications are most common among patients who develop COVID-19.

This alliance encourages rheumatologists and those caring for patients with rheumatic diseases to report their patient cases to this registry. As we are confronted with making management decisions with a scarcity of supporting data, efforts like these will improve our ability to make individualized treatment recommendations.

The COVID-19 pandemic has presented us all with unprecedented challenges. As rheumatologists, it is our duty to lead our patients through this uncharted territory with close communication, information, advocacy, and personalized treatment decisions. Each of these is central to the management of rheumatology patients during the COVID-19 pandemic.

With the growing interest in immunomodulatory therapies for the complications of this infection, we have the unique opportunity to share our expertise, recommendations, and caution with our colleagues. As clinicians and scientists, we must advocate for data collection and studies that will allow us to develop novel, data-driven disease management approaches while providing the best care possible for our patients.

Stephen Paget, MD, is physician in chief emeritus for the Center for Rheumatology at Hospital for Special Surgery in New York. Kimberly Showalter, MD, is a third-year rheumatology fellow at Hospital for Special Surgery. Sebastian E. Sattui, MD, is a third-year rheumatology and 1-year vasculitis fellow at Hospital for Special Surgery.

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

The COVID-19 pandemic continues to pose an unprecedented challenge to health care systems worldwide. In addition to the direct impact of the disease itself, there is a growing concern related to ensuring adequate health care utilization and addressing the needs of vulnerable populations, such as those with chronic illness.

Emanuel et al. have advocated a framework of fair allocation of resources, led by the principles of equity, maximizing benefits, and prioritizing the vulnerable. In these uncertain times, patients with rheumatic diseases represent a vulnerable population whose health and wellness are particularly threatened, not only by the risk of COVID-19, but also by reduced access to usual medical care (e.g., in-person clinic visits), potential treatment interruptions (e.g., planned infusion therapies), and the ongoing shortage of hydroxychloroquine, to name a few.

As rheumatologists, we are now tasked with the development of best practices for caring for patients with rheumatic conditions in this uncertain, evolving, and nearly data-free landscape. We also must maintain an active role as advocates for our patients to help them navigate this pandemic. Herein, we discuss our approach to caring for patients with rheumatic diseases within our practice in New York City, an epicenter of the COVID-19 pandemic.

Communication with patients

Maintaining an open line of communication with our patients (by phone, patient portal, telemedicine, and so on) has become more essential than ever. It is through these communications that we best understand our patients’ concerns and provide support and personalized treatment decisions. The most common questions we have received during recent weeks are:

• Should I stop my medication to lower my risk for infection?
• Are my current symptoms caused by coronavirus, and what should I do next?
• Where can I fill my hydroxychloroquine prescription?

The American College of Rheumatology has deployed a number of task forces aimed at advocating for rheumatologists and patients with rheumatic diseases and is doing an exemplary job guiding us. For patients, several other organizations (e.g., CreakyJoints, Arthritis Foundation, Lupus Research Alliance, Vasculitis Foundation, and Scleroderma Foundation) are also providing accurate information regarding hygiene practices, social distancing, management of medications, and other guidance related to specific rheumatic diseases. In line with ACR recommendations, we encourage a personalized, shared decision-making process with each of our patients.

Patients with rheumatic disease at risk for COVID-19 infection

First, for rheumatology patients who have no COVID-19 symptoms, our management approach is individualized. For patients who are able to maintain social distancing, we have not routinely stopped immunosuppressive medications, including disease-modifying antirheumatic drugs (DMARDs) and biologic agents. However, we discuss the risks and benefits of continuing immunosuppressive therapy during this time with all of our patients.

In certain cases of stable, non–life-threatening disease, we may consider spacing or temporarily interrupting immunosuppressive therapy, using individualized, shared decision making. Yet, it is important to recognize that, for some patients, achieving adequate disease control can require a substantial amount of time.

Furthermore, it is important to acknowledge that disease flares requiring steroid therapy may increase the risk for infection even more, keeping in mind that, in some rheumatic diseases, high disease activity itself can increase infection risk. We advise patients who are continuing therapy to maintain at least a 1-month supply of their medications.

Decisions regarding infusions in the hospital and outpatient settings are similarly made on an individual basis, weighing the risk for virus exposure against that of disease flare. The more limited availability of appropriately distanced infusion chairs in some already overburdened systems must be considered in this discussion. We agree with the ACR, whose infusion guidance recommends that “possible changes might include temporary interruption of therapy, temporary initiation of a bridge therapy such as a less potent anti-inflammatory or immune-modulating agent, or temporary change to an alternative therapy.”

We also reinforce recommended behaviors for preventing infection, including social distancing, frequent handwashing, and avoiding touching one’s face.

Patients with rheumatic disease and confirmed or suspected COVID-19 infection

With the worldwide spread of COVID-19, patients with rheumatic diseases will undoubtedly be among those exposed and infected. Though current data are limited, within a cohort from China, 1% had an autoimmune disease. Testing recommendations to confirm COVID-19 and decision guidelines for outpatient versus inpatient management are evolving, and we consult the most up-to-date, local information regarding testing as individual potential cases arise.

For patients who develop COVID-19 and are currently taking DMARDs and biologics, we recommend that they discontinue these medications, with the exception of hydroxychloroquine (HCQ). HCQ may be continued because its mechanism is not expected to worsen infection, and it plays a key role in the management of patients with systemic lupus erythematosus (SLE). In addition, in vitro antiviral effects have been reported and there is growing interest for its use in the management of COVID-19. However, there are conflicting data and methodological concerns about the nonrandomized human studies that suggest a benefit of HCQ against COVID-19.

The decision regarding management of glucocorticoids in the setting of new COVID-19 infection is challenging and should be individualized. At present, expert panels recommend against the use of glucocorticoids among individuals with COVID-19 who do not have acute respiratory distress syndrome. However, adrenal insufficiency must be considered among patients with COVID-19 who are treated with chronic glucocorticoids. Again, these decisions should be made on an individual, case-by-case basis.

Implications of a hydroxychloroquine shortage

The use of HCQ in rheumatology is supported by years of research. Particularly in SLE, HCQ has been shown to reduce disease activity and damage and to improve survival. Furthermore, for pregnant patients with SLE, numerous studies have demonstrated the safety and benefit of HCQ for both the mother and fetus; thus, it is strongly recommended. By contrast, despite the growing interest for HCQ in patients with COVID-19, the evidence is inconclusive and limited.

The ACR suggests that decisions regarding HCQ dose reductions to extend individual patients supplies should be tailored to each patient’s need and risk in the unfortunate setting of medication shortages. Even in patients with stable SLE, however, disease flares at 6 months are more common among individuals who discontinue HCQ. Of note, these flares may incorporate novel and severe disease manifestations.

Unfortunately, other therapeutic options for SLE are associated with more adverse effects (including increased susceptibility to infection) or are largely unavailable (e.g., quinacrine). Thus, we strive to continue standard dosing of HCQ for patients who are currently flaring or recently flared, and we make shared, individualized decisions for those patients with stable disease as the HCQ shortage evolves.

Future research on COVID-19 and rheumatic disease

While we might expect that an underlying rheumatic disease and associated treatments may predispose individuals to developing COVID-19, current data do not indicate which, if any, rheumatic diseases and associated therapies convey the greatest risk.

To address this uncertainty, the rheumatology community created the COVID-19 Global Rheumatology Alliance, an international effort to initiate and maintain a deidentified patient registry for individuals with rheumatic disease who develop COVID-19. These efforts will allow us to gain essential insights regarding which patient demographics, underlying diseases, and medications are most common among patients who develop COVID-19.

This alliance encourages rheumatologists and those caring for patients with rheumatic diseases to report their patient cases to this registry. As we are confronted with making management decisions with a scarcity of supporting data, efforts like these will improve our ability to make individualized treatment recommendations.

The COVID-19 pandemic has presented us all with unprecedented challenges. As rheumatologists, it is our duty to lead our patients through this uncharted territory with close communication, information, advocacy, and personalized treatment decisions. Each of these is central to the management of rheumatology patients during the COVID-19 pandemic.

With the growing interest in immunomodulatory therapies for the complications of this infection, we have the unique opportunity to share our expertise, recommendations, and caution with our colleagues. As clinicians and scientists, we must advocate for data collection and studies that will allow us to develop novel, data-driven disease management approaches while providing the best care possible for our patients.

Stephen Paget, MD, is physician in chief emeritus for the Center for Rheumatology at Hospital for Special Surgery in New York. Kimberly Showalter, MD, is a third-year rheumatology fellow at Hospital for Special Surgery. Sebastian E. Sattui, MD, is a third-year rheumatology and 1-year vasculitis fellow at Hospital for Special Surgery.

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

The slow-moving game of viral roulette is wearing on everyone. Eventually, we may all become fatigued and say, “well, let’s just take our chances,” the isolation being worse than the disease. I must say, however, the sight of the local funeral director loading lumber into his van at the hardware store last week made me snug up my mask a bit. We have had a surge of COVID-19 deaths in local nursing homes and I heard refrigerated space is tight. Who knows, though, maybe he just needed more shelf space in his garage.

The most exasperating thing is not knowing who has had the virus and who hasn’t, and what medicine might or might not work. My son, quartered in the sardine-tin bunks of an aircraft carrier has “it,” as do all his mates, is in total isolation except for fever checks once a day, and is having a tough time. His eagerness to receive our phone calls was sweet at first, but is now starting to worry me. Today, I received a letter from him, which I dutifully steam-microwaved for 5 minutes and am letting dry in the sun. He is asymptomatic by the way. This was not the case for one of my buddies in New York. He suffered through 10 days of shaking chills so bad he thought he had chipped his teeth, and weeks later he still has no sense of smell.

My practice has been completely disrupted, but we are open a couple of days a week. I have kept all my employees, doing busy things mostly. There will be long hours for everyone because of widely spaced appointments and a certain amount of friction with patients who miss appointments. My fellow is going to take a long trip in July. Who knows when he will have a month off again? I wonder where he plans to go.

We have rearranged the waiting room furniture, so everyone is 6 feet apart, though I am not confident this makes a difference. We all have masks, and use alcohol gel before and after patient encounters, and spritz all fixtures and handles with alcohol after encounters. I have a large exhaust fan in the lab that creates a negative pressure gradient in the office. Somehow, I don’t think it is quite the same as in the hospital.

One slick trick we’ve enacted is running an ozone generator in the office at night, which will kill all things on all surfaces and in the air. It also is probably eroding the insides of my computers, but hey, the insects and burglars hate it too.

We heard the fighter jets fly over today saluting the frontline health care workers, but did not go out and wave. We are taking care of skin cancers, and while my patients might have COVID, they do not have a fever or cough, and are not supposed to come in if they do. I feel a little guilt about this. Treating cancer is important, but we are not in the ICU or ED immersed in virus. That is who the jets are for.

My daughter, a high school senior, is taking the loss of graduation, prom, and pomp and circumstance quite well. I am relieved I don’t have to worry about the after-prom parties. She is gearing up for college, I just hope they allow classes to start.

The future is cloudy and uncertain, despite this beautiful spring day as I write this column. Surely the way we practice medicine is going to change, and for a long while. I am thinking of taking a part-time job out of town for a year or so, and my wife is considering closing her practice altogether. If we were a few years older, there is little doubt we would just move it down the line and retire.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He has no disclosures. Write to him at [email protected].

The slow-moving game of viral roulette is wearing on everyone. Eventually, we may all become fatigued and say, “well, let’s just take our chances,” the isolation being worse than the disease. I must say, however, the sight of the local funeral director loading lumber into his van at the hardware store last week made me snug up my mask a bit. We have had a surge of COVID-19 deaths in local nursing homes and I heard refrigerated space is tight. Who knows, though, maybe he just needed more shelf space in his garage.

The most exasperating thing is not knowing who has had the virus and who hasn’t, and what medicine might or might not work. My son, quartered in the sardine-tin bunks of an aircraft carrier has “it,” as do all his mates, is in total isolation except for fever checks once a day, and is having a tough time. His eagerness to receive our phone calls was sweet at first, but is now starting to worry me. Today, I received a letter from him, which I dutifully steam-microwaved for 5 minutes and am letting dry in the sun. He is asymptomatic by the way. This was not the case for one of my buddies in New York. He suffered through 10 days of shaking chills so bad he thought he had chipped his teeth, and weeks later he still has no sense of smell.

My practice has been completely disrupted, but we are open a couple of days a week. I have kept all my employees, doing busy things mostly. There will be long hours for everyone because of widely spaced appointments and a certain amount of friction with patients who miss appointments. My fellow is going to take a long trip in July. Who knows when he will have a month off again? I wonder where he plans to go.

We have rearranged the waiting room furniture, so everyone is 6 feet apart, though I am not confident this makes a difference. We all have masks, and use alcohol gel before and after patient encounters, and spritz all fixtures and handles with alcohol after encounters. I have a large exhaust fan in the lab that creates a negative pressure gradient in the office. Somehow, I don’t think it is quite the same as in the hospital.

One slick trick we’ve enacted is running an ozone generator in the office at night, which will kill all things on all surfaces and in the air. It also is probably eroding the insides of my computers, but hey, the insects and burglars hate it too.

We heard the fighter jets fly over today saluting the frontline health care workers, but did not go out and wave. We are taking care of skin cancers, and while my patients might have COVID, they do not have a fever or cough, and are not supposed to come in if they do. I feel a little guilt about this. Treating cancer is important, but we are not in the ICU or ED immersed in virus. That is who the jets are for.

My daughter, a high school senior, is taking the loss of graduation, prom, and pomp and circumstance quite well. I am relieved I don’t have to worry about the after-prom parties. She is gearing up for college, I just hope they allow classes to start.

The future is cloudy and uncertain, despite this beautiful spring day as I write this column. Surely the way we practice medicine is going to change, and for a long while. I am thinking of taking a part-time job out of town for a year or so, and my wife is considering closing her practice altogether. If we were a few years older, there is little doubt we would just move it down the line and retire.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He has no disclosures. Write to him at [email protected].

The slow-moving game of viral roulette is wearing on everyone. Eventually, we may all become fatigued and say, “well, let’s just take our chances,” the isolation being worse than the disease. I must say, however, the sight of the local funeral director loading lumber into his van at the hardware store last week made me snug up my mask a bit. We have had a surge of COVID-19 deaths in local nursing homes and I heard refrigerated space is tight. Who knows, though, maybe he just needed more shelf space in his garage.

The most exasperating thing is not knowing who has had the virus and who hasn’t, and what medicine might or might not work. My son, quartered in the sardine-tin bunks of an aircraft carrier has “it,” as do all his mates, is in total isolation except for fever checks once a day, and is having a tough time. His eagerness to receive our phone calls was sweet at first, but is now starting to worry me. Today, I received a letter from him, which I dutifully steam-microwaved for 5 minutes and am letting dry in the sun. He is asymptomatic by the way. This was not the case for one of my buddies in New York. He suffered through 10 days of shaking chills so bad he thought he had chipped his teeth, and weeks later he still has no sense of smell.

My practice has been completely disrupted, but we are open a couple of days a week. I have kept all my employees, doing busy things mostly. There will be long hours for everyone because of widely spaced appointments and a certain amount of friction with patients who miss appointments. My fellow is going to take a long trip in July. Who knows when he will have a month off again? I wonder where he plans to go.

We have rearranged the waiting room furniture, so everyone is 6 feet apart, though I am not confident this makes a difference. We all have masks, and use alcohol gel before and after patient encounters, and spritz all fixtures and handles with alcohol after encounters. I have a large exhaust fan in the lab that creates a negative pressure gradient in the office. Somehow, I don’t think it is quite the same as in the hospital.

One slick trick we’ve enacted is running an ozone generator in the office at night, which will kill all things on all surfaces and in the air. It also is probably eroding the insides of my computers, but hey, the insects and burglars hate it too.

We heard the fighter jets fly over today saluting the frontline health care workers, but did not go out and wave. We are taking care of skin cancers, and while my patients might have COVID, they do not have a fever or cough, and are not supposed to come in if they do. I feel a little guilt about this. Treating cancer is important, but we are not in the ICU or ED immersed in virus. That is who the jets are for.

My daughter, a high school senior, is taking the loss of graduation, prom, and pomp and circumstance quite well. I am relieved I don’t have to worry about the after-prom parties. She is gearing up for college, I just hope they allow classes to start.

The future is cloudy and uncertain, despite this beautiful spring day as I write this column. Surely the way we practice medicine is going to change, and for a long while. I am thinking of taking a part-time job out of town for a year or so, and my wife is considering closing her practice altogether. If we were a few years older, there is little doubt we would just move it down the line and retire.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. He has no disclosures. Write to him at [email protected].

For patients with chronic hepatitis B virus (HBV) infection, triple-combination therapy with tenofovir disoproxil fumarate, pegylated interferon alfa-2a (TDF-pegIFN), and either of two investigational nucleic acid polymers was tolerable and led to long-term functional cures in an open-label phase 2 trial.

The addition of either REP 2139 or REP 2165 to backbone TDF-pegIFN therapy produced functional cures in 39% of patients without lessening HBV DNA control or exacerbating treatment-induced neutropenia or thrombocytopenia, said Michel Bazinet, MD, of Replicor in Montreal and his associates. “Increases in levels of transaminases were significantly more frequent (P < .001 vs. controls) and greater (P = .002 vs. controls) in the nucleic acid polymer groups but did not produce symptoms, correlated with [an] initial decrease in hepatitis B surface antigen [HBsAg], and normalized during therapy and follow-up,” the investigators wrote in Gastroenterology.

Nucleic acid polymers (NAPs) suppress the assembly and secretion of HBV subviral particles. NAP monotherapy is active against HBV but usually does not provide long-term virologic control. In a small study, adding pegIFN or thymosin alpha-1 to an investigational NAP achieved functional control (HBsAg positive, HBV DNA ≤ 2000 IU/mL, and normal alanine aminotransferase levels) in eight of nine patients.

Building on these findings, two triple-combination NAP regimens were evaluated in 40 noncirrhotic HB envelope antigen–negative adults with chronic HBV infection. After 24 weeks of TDF monotherapy, participants were randomly assigned to either 48 weeks of REP 2139 or REP 2165 plus backbone therapy with TDF and pegIFN, or 24 weeks of backbone therapy followed by 48 weeks of triple-combination treatment. Patients were then followed without treatment for 24-48 weeks.

Backbone TDF-pegIFN therapy produced no HBsAg seroconversions, and HBsAg levels dropped by more than 1 log10 IU/mL in only three patients. In contrast, triple-combination NAP therapy produced undetectable HBsAg and HBsAg seroconversions (up to 233,055 mIU/mL) for 60% of patients. Among 36 patients followed for 24-48 weeks after completing treatment, 78% maintained virologic control and 39% showed functional cures (HBsAg < 0.05 IU/mL, undetectable HBV DNA, and normal ALT). “Additional follow-up is planned to confirm the long-term stability of [these] outcomes,” the researchers said.

Both NAPs were formulated with chelated magnesium to improve their tolerability. Although 95% of patients experienced transaminase flares, these “self-resolved or declined during continuing NAP therapy and normalized in 32 of 34 (94%) of participants completing 48 weeks of follow-up,” the researchers said. In keeping with prior studies, transaminase flares were associated with early declines in HBsAg but not with altered liver function or liver disease symptoms.

The study was conducted at three sites in Maldova. Most participants were men with HBV genotype D infection. “During follow-up, viral rebound occurred in participants [in whom] HBsAg was still detectable at the end of 48 weeks of combination therapy (≥ 57.9 IU/mL), who did not complete therapy, or [for whom] HBsAg clearance occurred very late in therapy,” the researchers wrote. Thus, “persistent exposure to pegIFN while HBsAg is cleared may be important for the establishment of virologic control and functional cure.” They recommended evaluating NAP plus nucleos(t)ide analogue (NUC) therapy to assess response in the absence of pegIFN. Such studies should enroll “NUC-experienced participants with well-controlled HBV DNA.”

Replicor provided funding. Dr. Bazinet and the senior investigator reported that they are employees and shareholders of Replicor and have invented patents that Replicor holds. One coinvestigator reported compensation from Replicor to his institution. The remaining 11 coinvestigators reported having no relevant disclosures.
 

SOURCE: Bazinet M et al. Gastroenterology. 2020 Mar 5. doi: 0.1053/j.gastro.2020.02.058.

For patients with chronic hepatitis B virus (HBV) infection, triple-combination therapy with tenofovir disoproxil fumarate, pegylated interferon alfa-2a (TDF-pegIFN), and either of two investigational nucleic acid polymers was tolerable and led to long-term functional cures in an open-label phase 2 trial.

The addition of either REP 2139 or REP 2165 to backbone TDF-pegIFN therapy produced functional cures in 39% of patients without lessening HBV DNA control or exacerbating treatment-induced neutropenia or thrombocytopenia, said Michel Bazinet, MD, of Replicor in Montreal and his associates. “Increases in levels of transaminases were significantly more frequent (P < .001 vs. controls) and greater (P = .002 vs. controls) in the nucleic acid polymer groups but did not produce symptoms, correlated with [an] initial decrease in hepatitis B surface antigen [HBsAg], and normalized during therapy and follow-up,” the investigators wrote in Gastroenterology.

Nucleic acid polymers (NAPs) suppress the assembly and secretion of HBV subviral particles. NAP monotherapy is active against HBV but usually does not provide long-term virologic control. In a small study, adding pegIFN or thymosin alpha-1 to an investigational NAP achieved functional control (HBsAg positive, HBV DNA ≤ 2000 IU/mL, and normal alanine aminotransferase levels) in eight of nine patients.

Building on these findings, two triple-combination NAP regimens were evaluated in 40 noncirrhotic HB envelope antigen–negative adults with chronic HBV infection. After 24 weeks of TDF monotherapy, participants were randomly assigned to either 48 weeks of REP 2139 or REP 2165 plus backbone therapy with TDF and pegIFN, or 24 weeks of backbone therapy followed by 48 weeks of triple-combination treatment. Patients were then followed without treatment for 24-48 weeks.

Backbone TDF-pegIFN therapy produced no HBsAg seroconversions, and HBsAg levels dropped by more than 1 log10 IU/mL in only three patients. In contrast, triple-combination NAP therapy produced undetectable HBsAg and HBsAg seroconversions (up to 233,055 mIU/mL) for 60% of patients. Among 36 patients followed for 24-48 weeks after completing treatment, 78% maintained virologic control and 39% showed functional cures (HBsAg < 0.05 IU/mL, undetectable HBV DNA, and normal ALT). “Additional follow-up is planned to confirm the long-term stability of [these] outcomes,” the researchers said.

Both NAPs were formulated with chelated magnesium to improve their tolerability. Although 95% of patients experienced transaminase flares, these “self-resolved or declined during continuing NAP therapy and normalized in 32 of 34 (94%) of participants completing 48 weeks of follow-up,” the researchers said. In keeping with prior studies, transaminase flares were associated with early declines in HBsAg but not with altered liver function or liver disease symptoms.

The study was conducted at three sites in Maldova. Most participants were men with HBV genotype D infection. “During follow-up, viral rebound occurred in participants [in whom] HBsAg was still detectable at the end of 48 weeks of combination therapy (≥ 57.9 IU/mL), who did not complete therapy, or [for whom] HBsAg clearance occurred very late in therapy,” the researchers wrote. Thus, “persistent exposure to pegIFN while HBsAg is cleared may be important for the establishment of virologic control and functional cure.” They recommended evaluating NAP plus nucleos(t)ide analogue (NUC) therapy to assess response in the absence of pegIFN. Such studies should enroll “NUC-experienced participants with well-controlled HBV DNA.”

Replicor provided funding. Dr. Bazinet and the senior investigator reported that they are employees and shareholders of Replicor and have invented patents that Replicor holds. One coinvestigator reported compensation from Replicor to his institution. The remaining 11 coinvestigators reported having no relevant disclosures.
 

SOURCE: Bazinet M et al. Gastroenterology. 2020 Mar 5. doi: 0.1053/j.gastro.2020.02.058.

For patients with chronic hepatitis B virus (HBV) infection, triple-combination therapy with tenofovir disoproxil fumarate, pegylated interferon alfa-2a (TDF-pegIFN), and either of two investigational nucleic acid polymers was tolerable and led to long-term functional cures in an open-label phase 2 trial.

The addition of either REP 2139 or REP 2165 to backbone TDF-pegIFN therapy produced functional cures in 39% of patients without lessening HBV DNA control or exacerbating treatment-induced neutropenia or thrombocytopenia, said Michel Bazinet, MD, of Replicor in Montreal and his associates. “Increases in levels of transaminases were significantly more frequent (P < .001 vs. controls) and greater (P = .002 vs. controls) in the nucleic acid polymer groups but did not produce symptoms, correlated with [an] initial decrease in hepatitis B surface antigen [HBsAg], and normalized during therapy and follow-up,” the investigators wrote in Gastroenterology.

Nucleic acid polymers (NAPs) suppress the assembly and secretion of HBV subviral particles. NAP monotherapy is active against HBV but usually does not provide long-term virologic control. In a small study, adding pegIFN or thymosin alpha-1 to an investigational NAP achieved functional control (HBsAg positive, HBV DNA ≤ 2000 IU/mL, and normal alanine aminotransferase levels) in eight of nine patients.

Building on these findings, two triple-combination NAP regimens were evaluated in 40 noncirrhotic HB envelope antigen–negative adults with chronic HBV infection. After 24 weeks of TDF monotherapy, participants were randomly assigned to either 48 weeks of REP 2139 or REP 2165 plus backbone therapy with TDF and pegIFN, or 24 weeks of backbone therapy followed by 48 weeks of triple-combination treatment. Patients were then followed without treatment for 24-48 weeks.

Backbone TDF-pegIFN therapy produced no HBsAg seroconversions, and HBsAg levels dropped by more than 1 log10 IU/mL in only three patients. In contrast, triple-combination NAP therapy produced undetectable HBsAg and HBsAg seroconversions (up to 233,055 mIU/mL) for 60% of patients. Among 36 patients followed for 24-48 weeks after completing treatment, 78% maintained virologic control and 39% showed functional cures (HBsAg < 0.05 IU/mL, undetectable HBV DNA, and normal ALT). “Additional follow-up is planned to confirm the long-term stability of [these] outcomes,” the researchers said.

Both NAPs were formulated with chelated magnesium to improve their tolerability. Although 95% of patients experienced transaminase flares, these “self-resolved or declined during continuing NAP therapy and normalized in 32 of 34 (94%) of participants completing 48 weeks of follow-up,” the researchers said. In keeping with prior studies, transaminase flares were associated with early declines in HBsAg but not with altered liver function or liver disease symptoms.

The study was conducted at three sites in Maldova. Most participants were men with HBV genotype D infection. “During follow-up, viral rebound occurred in participants [in whom] HBsAg was still detectable at the end of 48 weeks of combination therapy (≥ 57.9 IU/mL), who did not complete therapy, or [for whom] HBsAg clearance occurred very late in therapy,” the researchers wrote. Thus, “persistent exposure to pegIFN while HBsAg is cleared may be important for the establishment of virologic control and functional cure.” They recommended evaluating NAP plus nucleos(t)ide analogue (NUC) therapy to assess response in the absence of pegIFN. Such studies should enroll “NUC-experienced participants with well-controlled HBV DNA.”

Replicor provided funding. Dr. Bazinet and the senior investigator reported that they are employees and shareholders of Replicor and have invented patents that Replicor holds. One coinvestigator reported compensation from Replicor to his institution. The remaining 11 coinvestigators reported having no relevant disclosures.
 

SOURCE: Bazinet M et al. Gastroenterology. 2020 Mar 5. doi: 0.1053/j.gastro.2020.02.058.

Total underwater colonoscopy can surmount challenges with insertion, simplify endoscopic mucosal resection, and lessen pain and the need for sedation, according to a “Here and Now: Clinical Practice” article published in Clinical Gastroenterology and Hepatology.

At the same time, total underwater colonoscopy has not been shown to significantly affect adenoma miss rates, requires a longer insertion and overall procedure time, and cannot be performed without adequate bowel preparation, wrote Joseph C. Anderson, MD, of the Department of Veterans Affairs Medical Center in White River Junction, Vt., and the Geisel School of Medicine at Dartmouth, Hanover, N.H.

He noted that total underwater colonoscopy is not the same as water immersion or water exchange, both of which involve infusing water while inserting the colonoscope and then distending the colon with carbon dioxide to visualize the mucosa during withdrawal. During total underwater colonoscopy, insertion, examination, and resection all are carried out with the lumen filled with water. Air is suctioned out, and the air valve is kept off.

This approach can surmount problems with insertion stemming from either severe angulation (often of the sigmoid colon), or redundant colon (excessive looping) that does not respond to abdominal pressure, colonoscope stiffening, or a change in position, Dr. Anderson noted. He explained that, unlike air, water does not maximally distend the lumen and therefore does not exacerbate angulation. “When I am in the ascending colon and cannot reach the cecum, I turn off the air valve, aspirate all gas, infuse water, and complete the insertion underwater,” he said. “Another advantage of water in patients with angulated sigmoid colons is that its use could prevent [the] excessive use of air and potential barotrauma of the cecum, even when using carbon dioxide.”

The use of water can aid endoscopic mucosal resection (EMR) because polyps tend to float into view (including from hard-to-visualize areas, such as folds) and into the snare, he said. “Because water has a magnifying property, underwater EMR may allow for easier delineation of the polyp’s border, also facilitating complete removal.”

Nonetheless, it remains unclear whether the use of total underwater colonoscopy significantly affects adenoma detection rates. In a recent study, Dr. Anderson and his coinvestiators randomly assigned 121 patients to undergo either colonoscopy with carbon dioxide insufflation, followed by total underwater colonoscopy, or the same examinations in the reverse sequence (Anderson KC et al. Gastrointest Endosc. 2019;89:591-8). Adenoma miss rates were statistically similar between groups. Although water decreases green mucus and residual stool and suspends “unsuctionable” particles (e.g. seeds) into the cecal lumen, where colonoscopists can better see past them, water also increases the production of white mucus, which can be difficult to remove during withdrawal, Dr. Anderson said.

He cited meta-analyses in which colonoscopies performed with water, without sedation or with minimal sedation, were associated with less pain and a higher likelihood of performing a complete examination than when only air was used. “I find this [approach] particularly useful in older, thinner patients, especially women,” Dr. Anderson said. “In addition, in patients with multiple comorbidities, cecal intubation often can be achieved safely with minimal sedation.”

Dr. Anderson reported having no relevant conflicts of interest.

SOURCE: Anderson JC. Clin Gastroenterol Hepatol. 2020 Feb 25. doi: 10.1016/j.cgh.2020.02.042.

Total underwater colonoscopy can surmount challenges with insertion, simplify endoscopic mucosal resection, and lessen pain and the need for sedation, according to a “Here and Now: Clinical Practice” article published in Clinical Gastroenterology and Hepatology.

At the same time, total underwater colonoscopy has not been shown to significantly affect adenoma miss rates, requires a longer insertion and overall procedure time, and cannot be performed without adequate bowel preparation, wrote Joseph C. Anderson, MD, of the Department of Veterans Affairs Medical Center in White River Junction, Vt., and the Geisel School of Medicine at Dartmouth, Hanover, N.H.

He noted that total underwater colonoscopy is not the same as water immersion or water exchange, both of which involve infusing water while inserting the colonoscope and then distending the colon with carbon dioxide to visualize the mucosa during withdrawal. During total underwater colonoscopy, insertion, examination, and resection all are carried out with the lumen filled with water. Air is suctioned out, and the air valve is kept off.

This approach can surmount problems with insertion stemming from either severe angulation (often of the sigmoid colon), or redundant colon (excessive looping) that does not respond to abdominal pressure, colonoscope stiffening, or a change in position, Dr. Anderson noted. He explained that, unlike air, water does not maximally distend the lumen and therefore does not exacerbate angulation. “When I am in the ascending colon and cannot reach the cecum, I turn off the air valve, aspirate all gas, infuse water, and complete the insertion underwater,” he said. “Another advantage of water in patients with angulated sigmoid colons is that its use could prevent [the] excessive use of air and potential barotrauma of the cecum, even when using carbon dioxide.”

The use of water can aid endoscopic mucosal resection (EMR) because polyps tend to float into view (including from hard-to-visualize areas, such as folds) and into the snare, he said. “Because water has a magnifying property, underwater EMR may allow for easier delineation of the polyp’s border, also facilitating complete removal.”

Nonetheless, it remains unclear whether the use of total underwater colonoscopy significantly affects adenoma detection rates. In a recent study, Dr. Anderson and his coinvestiators randomly assigned 121 patients to undergo either colonoscopy with carbon dioxide insufflation, followed by total underwater colonoscopy, or the same examinations in the reverse sequence (Anderson KC et al. Gastrointest Endosc. 2019;89:591-8). Adenoma miss rates were statistically similar between groups. Although water decreases green mucus and residual stool and suspends “unsuctionable” particles (e.g. seeds) into the cecal lumen, where colonoscopists can better see past them, water also increases the production of white mucus, which can be difficult to remove during withdrawal, Dr. Anderson said.

He cited meta-analyses in which colonoscopies performed with water, without sedation or with minimal sedation, were associated with less pain and a higher likelihood of performing a complete examination than when only air was used. “I find this [approach] particularly useful in older, thinner patients, especially women,” Dr. Anderson said. “In addition, in patients with multiple comorbidities, cecal intubation often can be achieved safely with minimal sedation.”

Dr. Anderson reported having no relevant conflicts of interest.

SOURCE: Anderson JC. Clin Gastroenterol Hepatol. 2020 Feb 25. doi: 10.1016/j.cgh.2020.02.042.

Total underwater colonoscopy can surmount challenges with insertion, simplify endoscopic mucosal resection, and lessen pain and the need for sedation, according to a “Here and Now: Clinical Practice” article published in Clinical Gastroenterology and Hepatology.

At the same time, total underwater colonoscopy has not been shown to significantly affect adenoma miss rates, requires a longer insertion and overall procedure time, and cannot be performed without adequate bowel preparation, wrote Joseph C. Anderson, MD, of the Department of Veterans Affairs Medical Center in White River Junction, Vt., and the Geisel School of Medicine at Dartmouth, Hanover, N.H.

He noted that total underwater colonoscopy is not the same as water immersion or water exchange, both of which involve infusing water while inserting the colonoscope and then distending the colon with carbon dioxide to visualize the mucosa during withdrawal. During total underwater colonoscopy, insertion, examination, and resection all are carried out with the lumen filled with water. Air is suctioned out, and the air valve is kept off.

This approach can surmount problems with insertion stemming from either severe angulation (often of the sigmoid colon), or redundant colon (excessive looping) that does not respond to abdominal pressure, colonoscope stiffening, or a change in position, Dr. Anderson noted. He explained that, unlike air, water does not maximally distend the lumen and therefore does not exacerbate angulation. “When I am in the ascending colon and cannot reach the cecum, I turn off the air valve, aspirate all gas, infuse water, and complete the insertion underwater,” he said. “Another advantage of water in patients with angulated sigmoid colons is that its use could prevent [the] excessive use of air and potential barotrauma of the cecum, even when using carbon dioxide.”

The use of water can aid endoscopic mucosal resection (EMR) because polyps tend to float into view (including from hard-to-visualize areas, such as folds) and into the snare, he said. “Because water has a magnifying property, underwater EMR may allow for easier delineation of the polyp’s border, also facilitating complete removal.”

Nonetheless, it remains unclear whether the use of total underwater colonoscopy significantly affects adenoma detection rates. In a recent study, Dr. Anderson and his coinvestiators randomly assigned 121 patients to undergo either colonoscopy with carbon dioxide insufflation, followed by total underwater colonoscopy, or the same examinations in the reverse sequence (Anderson KC et al. Gastrointest Endosc. 2019;89:591-8). Adenoma miss rates were statistically similar between groups. Although water decreases green mucus and residual stool and suspends “unsuctionable” particles (e.g. seeds) into the cecal lumen, where colonoscopists can better see past them, water also increases the production of white mucus, which can be difficult to remove during withdrawal, Dr. Anderson said.

He cited meta-analyses in which colonoscopies performed with water, without sedation or with minimal sedation, were associated with less pain and a higher likelihood of performing a complete examination than when only air was used. “I find this [approach] particularly useful in older, thinner patients, especially women,” Dr. Anderson said. “In addition, in patients with multiple comorbidities, cecal intubation often can be achieved safely with minimal sedation.”

Dr. Anderson reported having no relevant conflicts of interest.

SOURCE: Anderson JC. Clin Gastroenterol Hepatol. 2020 Feb 25. doi: 10.1016/j.cgh.2020.02.042.

While discussing the difficult decisions to be made if the SARS-CoV-2 pandemic outlasts emergency funds from the Paycheck Protection and Economic Injury Disaster loan programs in my last column, I suggested calculating your overhead – that is, the cost structure supporting the generation of revenue within your practice. Once you know your overhead, you can consider options for managing both costs and revenue during this critical period and beyond.

Kativ/iStockphoto

Based on the flood of questions I’ve received, it appears that many private practitioners do not know how to do those things. Those who do are prone to comparing their overhead figures with those of other offices or with some arbitrary national average. For example, an internist who has calculated his or her practice’s overhead at 65% is dismayed when a surgical colleague reports an overhead of only 35%. Or perhaps the internist reads that the “average” overhead for a practice of that size should never be more than, say, 50%.

First, it is essential to compare apples to apples. Medical practices have entirely different cost structures than do surgical practices. Within those categories, overheads can still vary widely. For example, a neurologist who spends most of the day doing consults in inpatient settings will have substantially different costs than does a dermatologist whose practice is almost entirely office based. Even within similar practices, what one office incorporates in its cost structure may be quite different than another. One may include performance bonuses, while another may factor in automobile allowances – or not. It is important to understand what you are comparing.

Once you have a firm understanding of your overhead, you must decide how to measure it. Typically, that is done as either a percentage (expenses divided by revenue) or as a straight dollar figure.

While everyone’s situation will be different, most accountants and practice consultants recommend looking at percentages. As I have written many times in the past, lower overhead cost, in dollars, doesn’t necessarily mean lower expenses. If your practice can generate more revenue by increasing your expenses, the higher revenue per dollar will result in a lower percentage.

For example, hypothetical Practice A generates $1,000,000 per year on costs of $500,000; Practice B generates $3,000,000 on costs of $1,000,000. Practice B has double the overhead costs of A; yet it brings in triple the revenue, generating more revenue per dollar spent, and making its overhead percentage lower (33% vs. 50%).

Of course, to manage your overhead percentage, you must look at both costs and revenue. Once again, everyone’s situation is different; but here are some general tips for managing costs:

• If you don’t have a budget, create one now, and measure your actual costs against it. Many private practices still operate without budgets, but you can’t manage what you don’t measure.
• Understand your costs. What drives them? What causes them to increase? Which ones are fixed, and which are variable?
• Get competitive bids on a regular basis for supplies, equipment, and outsourced services. Review your invoices monthly to ensure there is no “cost creep” – extra charges, or continued charges for discontinued items. One practice I worked with discovered that it was still making monthly lease payments on equipment that it had disposed of years before!

Equally important is managing revenue. To do this efficiently:

• Maximize documentation and coding. Other columnists and I have written extensively on this subject over the years.
• Ensure that your bookkeeping team challenges all claim denials, and follows up in a timely manner.
• Train your staff in effective patient collection techniques, and make sure they keep up on rule changes. If you haven’t started asking each patient for a credit card number, so that you can bill patient-owed portions after insurance payments come in, now would be a good time to start.
• Evaluate new ways of generating revenue; think outside the box.

Managing overhead requires conscious, consistent, and continuous oversight.

As I wrote in the May column, I sincerely hope that all of our practices will return to some semblance of normal in the coming months; but we cannot assume a best possible scenario. And even ideal scenarios suggest that overhead management will be more important than ever in future years.

As always, consult with your own attorney, accountant, and other business advisers before making any life-altering decisions.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. He has no disclosures. Write to him at [email protected].

While discussing the difficult decisions to be made if the SARS-CoV-2 pandemic outlasts emergency funds from the Paycheck Protection and Economic Injury Disaster loan programs in my last column, I suggested calculating your overhead – that is, the cost structure supporting the generation of revenue within your practice. Once you know your overhead, you can consider options for managing both costs and revenue during this critical period and beyond.

Kativ/iStockphoto

Based on the flood of questions I’ve received, it appears that many private practitioners do not know how to do those things. Those who do are prone to comparing their overhead figures with those of other offices or with some arbitrary national average. For example, an internist who has calculated his or her practice’s overhead at 65% is dismayed when a surgical colleague reports an overhead of only 35%. Or perhaps the internist reads that the “average” overhead for a practice of that size should never be more than, say, 50%.

First, it is essential to compare apples to apples. Medical practices have entirely different cost structures than do surgical practices. Within those categories, overheads can still vary widely. For example, a neurologist who spends most of the day doing consults in inpatient settings will have substantially different costs than does a dermatologist whose practice is almost entirely office based. Even within similar practices, what one office incorporates in its cost structure may be quite different than another. One may include performance bonuses, while another may factor in automobile allowances – or not. It is important to understand what you are comparing.

Once you have a firm understanding of your overhead, you must decide how to measure it. Typically, that is done as either a percentage (expenses divided by revenue) or as a straight dollar figure.

While everyone’s situation will be different, most accountants and practice consultants recommend looking at percentages. As I have written many times in the past, lower overhead cost, in dollars, doesn’t necessarily mean lower expenses. If your practice can generate more revenue by increasing your expenses, the higher revenue per dollar will result in a lower percentage.

For example, hypothetical Practice A generates $1,000,000 per year on costs of $500,000; Practice B generates $3,000,000 on costs of $1,000,000. Practice B has double the overhead costs of A; yet it brings in triple the revenue, generating more revenue per dollar spent, and making its overhead percentage lower (33% vs. 50%).

Of course, to manage your overhead percentage, you must look at both costs and revenue. Once again, everyone’s situation is different; but here are some general tips for managing costs:

• If you don’t have a budget, create one now, and measure your actual costs against it. Many private practices still operate without budgets, but you can’t manage what you don’t measure.
• Understand your costs. What drives them? What causes them to increase? Which ones are fixed, and which are variable?
• Get competitive bids on a regular basis for supplies, equipment, and outsourced services. Review your invoices monthly to ensure there is no “cost creep” – extra charges, or continued charges for discontinued items. One practice I worked with discovered that it was still making monthly lease payments on equipment that it had disposed of years before!

Equally important is managing revenue. To do this efficiently:

• Maximize documentation and coding. Other columnists and I have written extensively on this subject over the years.
• Ensure that your bookkeeping team challenges all claim denials, and follows up in a timely manner.
• Train your staff in effective patient collection techniques, and make sure they keep up on rule changes. If you haven’t started asking each patient for a credit card number, so that you can bill patient-owed portions after insurance payments come in, now would be a good time to start.
• Evaluate new ways of generating revenue; think outside the box.

Managing overhead requires conscious, consistent, and continuous oversight.

As I wrote in the May column, I sincerely hope that all of our practices will return to some semblance of normal in the coming months; but we cannot assume a best possible scenario. And even ideal scenarios suggest that overhead management will be more important than ever in future years.

As always, consult with your own attorney, accountant, and other business advisers before making any life-altering decisions.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. He has no disclosures. Write to him at [email protected].

While discussing the difficult decisions to be made if the SARS-CoV-2 pandemic outlasts emergency funds from the Paycheck Protection and Economic Injury Disaster loan programs in my last column, I suggested calculating your overhead – that is, the cost structure supporting the generation of revenue within your practice. Once you know your overhead, you can consider options for managing both costs and revenue during this critical period and beyond.

Kativ/iStockphoto

Based on the flood of questions I’ve received, it appears that many private practitioners do not know how to do those things. Those who do are prone to comparing their overhead figures with those of other offices or with some arbitrary national average. For example, an internist who has calculated his or her practice’s overhead at 65% is dismayed when a surgical colleague reports an overhead of only 35%. Or perhaps the internist reads that the “average” overhead for a practice of that size should never be more than, say, 50%.

First, it is essential to compare apples to apples. Medical practices have entirely different cost structures than do surgical practices. Within those categories, overheads can still vary widely. For example, a neurologist who spends most of the day doing consults in inpatient settings will have substantially different costs than does a dermatologist whose practice is almost entirely office based. Even within similar practices, what one office incorporates in its cost structure may be quite different than another. One may include performance bonuses, while another may factor in automobile allowances – or not. It is important to understand what you are comparing.

Once you have a firm understanding of your overhead, you must decide how to measure it. Typically, that is done as either a percentage (expenses divided by revenue) or as a straight dollar figure.

While everyone’s situation will be different, most accountants and practice consultants recommend looking at percentages. As I have written many times in the past, lower overhead cost, in dollars, doesn’t necessarily mean lower expenses. If your practice can generate more revenue by increasing your expenses, the higher revenue per dollar will result in a lower percentage.

For example, hypothetical Practice A generates $1,000,000 per year on costs of $500,000; Practice B generates $3,000,000 on costs of $1,000,000. Practice B has double the overhead costs of A; yet it brings in triple the revenue, generating more revenue per dollar spent, and making its overhead percentage lower (33% vs. 50%).

Of course, to manage your overhead percentage, you must look at both costs and revenue. Once again, everyone’s situation is different; but here are some general tips for managing costs:

• If you don’t have a budget, create one now, and measure your actual costs against it. Many private practices still operate without budgets, but you can’t manage what you don’t measure.
• Understand your costs. What drives them? What causes them to increase? Which ones are fixed, and which are variable?
• Get competitive bids on a regular basis for supplies, equipment, and outsourced services. Review your invoices monthly to ensure there is no “cost creep” – extra charges, or continued charges for discontinued items. One practice I worked with discovered that it was still making monthly lease payments on equipment that it had disposed of years before!

Equally important is managing revenue. To do this efficiently:

• Maximize documentation and coding. Other columnists and I have written extensively on this subject over the years.
• Ensure that your bookkeeping team challenges all claim denials, and follows up in a timely manner.
• Train your staff in effective patient collection techniques, and make sure they keep up on rule changes. If you haven’t started asking each patient for a credit card number, so that you can bill patient-owed portions after insurance payments come in, now would be a good time to start.
• Evaluate new ways of generating revenue; think outside the box.

Managing overhead requires conscious, consistent, and continuous oversight.

As I wrote in the May column, I sincerely hope that all of our practices will return to some semblance of normal in the coming months; but we cannot assume a best possible scenario. And even ideal scenarios suggest that overhead management will be more important than ever in future years.

As always, consult with your own attorney, accountant, and other business advisers before making any life-altering decisions.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. He has no disclosures. Write to him at [email protected].

The health care costs of patients with nonalcoholic fatty liver disease (NAFLD) were nearly twice that of matched population controls, according to the results of a longitudinal cohort study.

Patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) were hospitalized an average of 0.27 times per year versus 0.16 times for controls (P < .001), for an annual incremental cost of $635, reported Hannes Hagström, MD, PhD, of Karolinska University Hospital in Stockholm. Patients with NAFLD also made significantly more outpatient care visits than controls (P < .001), he said. “Patients with advanced fibrosis [had] the highest costs, suggesting that reducing fibrosis progression is important to reduce future health care costs” among patients with NASH, Dr. Hagström and his associates wrote in Clinical Gastroenterology and Hepatology.

The retrospective longitudinal cohort study included all 646 patients diagnosed with biopsy-confirmed NAFLD at two hospitals in Sweden between 1971 and 2019. Patients with other liver diseases were excluded, as were heavy drinkers: men who drank more than 30 g of alcohol (just under four units) daily and women who drank more than 20 g daily. Each patient with NAFLD was matched with 10 population controls matched by age, sex, and county of residence.

Over a mean of 19.9 years of follow-up (range, 0-40 years), patients with NASH were hospitalized a total of 3,478 times, an average of 5.4 hospitalizations per patient. Controls were hospitalized an average of 3.2 times during the same time period (P < .001 vs. NASH patients). “This corresponded to a higher incremental cost in NAFLD patients of $635 per year (95% confidence interval, $407-$864; P < .001),” the researchers reported.

Between 2001 and 2009, patients with NAFLD averaged 5.4 more outpatient visits than controls (P < .001), with annual averages of 1.46 versus 0.86 visits (P < .001). Consequently, patient with NASH incurred $255 more per year in annual outpatient care costs. Liver disease accounted for 6% of outpatient care costs among NASH patients versus 0.2% of costs among controls.

“Cumulative costs in the [fibrosis stage 3 and 4] subgroup were relatively matched with the control population until around year 4 after biopsy, when costs diverged,” the researchers said. “This could possibly be an effect of the larger F3 population developing cirrhosis and increasing costs due to decompensation events.”

They noted that the rising prevalence of NAFLD will further burden health care budgets. “Costs [among patients with NASH] were higher in conjunction with liver biopsy, which is why using noninvasive diagnostic methods (e.g., transient elastography) is likely to reduce total costs,” they added. Of note, although patients with NAFLD also incurred somewhat more per year in prescription costs, the difference was not statistically significant.

The study was supported by Stockholm City Council, the Bengt Ihre Foundation, the County Council of Östergötland, and Gilead. The researchers reported having no conflicts of interest.

SOURCE: Kim H et al. Clin Gastroenterol Hepatol. 2019 Sep 12. doi: 10.1016/j.cgh.2019.10.023.

The health care costs of patients with nonalcoholic fatty liver disease (NAFLD) were nearly twice that of matched population controls, according to the results of a longitudinal cohort study.

Patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) were hospitalized an average of 0.27 times per year versus 0.16 times for controls (P < .001), for an annual incremental cost of $635, reported Hannes Hagström, MD, PhD, of Karolinska University Hospital in Stockholm. Patients with NAFLD also made significantly more outpatient care visits than controls (P < .001), he said. “Patients with advanced fibrosis [had] the highest costs, suggesting that reducing fibrosis progression is important to reduce future health care costs” among patients with NASH, Dr. Hagström and his associates wrote in Clinical Gastroenterology and Hepatology.

The retrospective longitudinal cohort study included all 646 patients diagnosed with biopsy-confirmed NAFLD at two hospitals in Sweden between 1971 and 2019. Patients with other liver diseases were excluded, as were heavy drinkers: men who drank more than 30 g of alcohol (just under four units) daily and women who drank more than 20 g daily. Each patient with NAFLD was matched with 10 population controls matched by age, sex, and county of residence.

Over a mean of 19.9 years of follow-up (range, 0-40 years), patients with NASH were hospitalized a total of 3,478 times, an average of 5.4 hospitalizations per patient. Controls were hospitalized an average of 3.2 times during the same time period (P < .001 vs. NASH patients). “This corresponded to a higher incremental cost in NAFLD patients of $635 per year (95% confidence interval, $407-$864; P < .001),” the researchers reported.

Between 2001 and 2009, patients with NAFLD averaged 5.4 more outpatient visits than controls (P < .001), with annual averages of 1.46 versus 0.86 visits (P < .001). Consequently, patient with NASH incurred $255 more per year in annual outpatient care costs. Liver disease accounted for 6% of outpatient care costs among NASH patients versus 0.2% of costs among controls.

“Cumulative costs in the [fibrosis stage 3 and 4] subgroup were relatively matched with the control population until around year 4 after biopsy, when costs diverged,” the researchers said. “This could possibly be an effect of the larger F3 population developing cirrhosis and increasing costs due to decompensation events.”

They noted that the rising prevalence of NAFLD will further burden health care budgets. “Costs [among patients with NASH] were higher in conjunction with liver biopsy, which is why using noninvasive diagnostic methods (e.g., transient elastography) is likely to reduce total costs,” they added. Of note, although patients with NAFLD also incurred somewhat more per year in prescription costs, the difference was not statistically significant.

The study was supported by Stockholm City Council, the Bengt Ihre Foundation, the County Council of Östergötland, and Gilead. The researchers reported having no conflicts of interest.

SOURCE: Kim H et al. Clin Gastroenterol Hepatol. 2019 Sep 12. doi: 10.1016/j.cgh.2019.10.023.

The health care costs of patients with nonalcoholic fatty liver disease (NAFLD) were nearly twice that of matched population controls, according to the results of a longitudinal cohort study.

Patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) were hospitalized an average of 0.27 times per year versus 0.16 times for controls (P < .001), for an annual incremental cost of $635, reported Hannes Hagström, MD, PhD, of Karolinska University Hospital in Stockholm. Patients with NAFLD also made significantly more outpatient care visits than controls (P < .001), he said. “Patients with advanced fibrosis [had] the highest costs, suggesting that reducing fibrosis progression is important to reduce future health care costs” among patients with NASH, Dr. Hagström and his associates wrote in Clinical Gastroenterology and Hepatology.

The retrospective longitudinal cohort study included all 646 patients diagnosed with biopsy-confirmed NAFLD at two hospitals in Sweden between 1971 and 2019. Patients with other liver diseases were excluded, as were heavy drinkers: men who drank more than 30 g of alcohol (just under four units) daily and women who drank more than 20 g daily. Each patient with NAFLD was matched with 10 population controls matched by age, sex, and county of residence.

Over a mean of 19.9 years of follow-up (range, 0-40 years), patients with NASH were hospitalized a total of 3,478 times, an average of 5.4 hospitalizations per patient. Controls were hospitalized an average of 3.2 times during the same time period (P < .001 vs. NASH patients). “This corresponded to a higher incremental cost in NAFLD patients of $635 per year (95% confidence interval, $407-$864; P < .001),” the researchers reported.

Between 2001 and 2009, patients with NAFLD averaged 5.4 more outpatient visits than controls (P < .001), with annual averages of 1.46 versus 0.86 visits (P < .001). Consequently, patient with NASH incurred $255 more per year in annual outpatient care costs. Liver disease accounted for 6% of outpatient care costs among NASH patients versus 0.2% of costs among controls.

“Cumulative costs in the [fibrosis stage 3 and 4] subgroup were relatively matched with the control population until around year 4 after biopsy, when costs diverged,” the researchers said. “This could possibly be an effect of the larger F3 population developing cirrhosis and increasing costs due to decompensation events.”

They noted that the rising prevalence of NAFLD will further burden health care budgets. “Costs [among patients with NASH] were higher in conjunction with liver biopsy, which is why using noninvasive diagnostic methods (e.g., transient elastography) is likely to reduce total costs,” they added. Of note, although patients with NAFLD also incurred somewhat more per year in prescription costs, the difference was not statistically significant.

The study was supported by Stockholm City Council, the Bengt Ihre Foundation, the County Council of Östergötland, and Gilead. The researchers reported having no conflicts of interest.

SOURCE: Kim H et al. Clin Gastroenterol Hepatol. 2019 Sep 12. doi: 10.1016/j.cgh.2019.10.023.

The prolonged and unique stresses imparted by the COVID-19 pandemic has many predicting a significant rise in mental health issues in the weeks, months, and years ahead.

To understand how health care workers can best get ahead of this emerging crisis within a crisis, Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Sheila Rauch, PhD, who’s with the Department of Psychiatry and Behavioral Sciences at the Emory University, Atlanta. The director of Mental Health Research and Program Evaluation at the Atlanta VA Medical Center, Dr. Rauch has studied the effects of and best treatments for posttraumatic stress disorder (PTSD) and anxiety disorders over the past 20 years.
 

Are we going to see a PTSD or anxiety epidemic as a result of the pandemic?

First, I think it’s really important that we prepare for the worst but hope for the best. But I would expect that, given the high levels of stress, the impact on resources, and other factors, we are going to see a pretty significant mental health impact over time. This could be the new normal for a while. Some of that will be PTSD, but there will also be other things. I would suspect that the resulting increase in rates of depression, traumatic grief, and loss is probably going to be a significant issue for years to come.

What will the anxiety we see as a result of COVID-19 look like compared with that seen in past disasters, like 9/11?

Most disasters in recent history, like 9/11, are single incidents. Something horrible happened, it impacted people at different levels, and we were able to start putting the pieces back together right away. The prolonged nature of this pandemic makes it even more variable given that the impact is going to be extended over time.

We’re also going to see a lot more people with compound impact – people who’ve lost their jobs, loved ones, maybe even their homes. All of those financial and resource losses put people in a higher risk category for negative mental health outcomes.
 

Is this analogous to the prolonged trauma that can occur with military service during war?

There is some similarity there. Combat is kind of an overarching context in which people experience trauma and, much like this pandemic, may or may not have traumatic exposures during it.

We’re asking health care workers to actually be in a role similar to what we ask of our military: going into danger, sometimes even without proper protective equipment, in order to save the lives of others. That’s also something we need to be factoring in as we plan to support those people and their families.
 

This is an ongoing incident, but is there a time window we need to be particularly worried about for seeing spikes in anxiety and PTSD?

I think we’re going to see variability on that. PTSD is a disorder that’s related to a specific incident or a couple of incidents that are similar. It’s a memory that’s haunting you.

For instance, typically if you have a combat veteran who has PTSD, they’ve been exposed to the overarching context of combat but then they have specific memories that are stuck. If they don’t have PTSD about 3-6 months after those incidents happen, then we would expect that they will not develop it, or it’s much less common that they would.

Depression has a very different course. It’s more prolonged and tends to grow with time.
 

Are you already seeing increased symptoms in your patients?

We’re seeing more anxiety, a lot of frustration, and a lot of very strong feelings about the leadership decisions that are being made. This is pretty similar to what we see in combat veterans. They’ll often be unhappy with the leadership decisions that were made as they were being deployed.

We’re also seeing lots more anger, sadness, and isolation now. Especially over the past couple of weeks, we’ve seen a rise in things like people reaching out for help in our intakes because we’re still open and doing phone assessments and telehealth with veterans and the veterans program.
 

In terms of interventions for this, what should psychiatrists, psychologists, and other clinicians be thinking about?

Right now, the best thing that we can do as mental health providers for people affected by the trauma is provide crisis intervention for those saying they are a danger to themselves and others. That means providing coping strategies and support. It also means making sure people are taking breaks and taking care of themselves, taking that little bit of time off so that they can go back, fully recharged, to their jobs and really stay there.

As we move forward, it will be clearer whether people are going to naturally recover, which most people will. For those who are going to have ongoing problems with time, we need to be getting ready as a system and as a country for those long-term mental health issues that are going to be coming up. And when I say long-term, it means the next 1-3 months. We want to be providing preventive interventions, versions of prolonged exposure, and other things that have shown some help in preventing PTSD. Psychological first aid is helpful.

There’s also an app called COVID Coach that the National Center for PTSD has created. That features a lot of positive coping resources together in one source.

Then when we get to the middle of that point and beyond it, we need to be ready to provide those evidence-based interventions for PTSD, depression, panic disorder, and other issues that are going to come out of this current situation.

But we were already short-staffed as far as mental health resources in general across the country, and especially in rural areas. So that means finding ways to efficiently use what we have through potentially briefer versions of interventions, through primary care, mental health, and other staff.
 

In what ways can primary care providers help?

There are versions of prolonged exposure therapy for primary care. That’s one of my big areas of research – increasing access. That would be something that we need to be building, by training and embedding mental health providers in primary care settings so that they can help to accommodate the increased need for access that’s going to be showing up for the next, I would suspect, several years with the pandemic.

Is there evidence that a prior episode of PTSD or traumatic experience like combat influences a subsequent reaction to a trauma like this?

It depends on how they manage. Research suggests that veterans or other people who have experienced trauma and naturally recovered, or who have gotten good treatment and remitted from that issue, are probably at no higher risk. But people who have subsyndromal PTSD or depression, or who are still experiencing symptoms from a history of trauma exposure, are maybe at a higher risk of having problems over time.

Do you have any guidance for healthcare providers on how to approach the pandemic with their patients, and also on how they can look after their own mental health?

In talking to patients, make sure that they have what they need. Ask if they’ve thought through how they’re going to cope if things get harder for them.

For people who have preexisting mental health issues, I’m talking with them about whether things have gotten worse. If they’re at high risk for suicide, I’m checking in to make sure that they’ve got new plans and ways to connect with people to reduce isolation, keeping in mind the social distancing that we’re asked to engage in so that they can do that safely.

It’s important to check and see if they have had any losses, whether it’s a financial loss or a personal loss of people that they care about. Also have them think through ways to stay entertained, which tends to help manage their own anxiety.

Every coping strategy we outline for patients also applies to mental health professionals. However, you would add to it the real need to take time to recharge, to take breaks, time off. It can feel overwhelming and like you need to just keep going. But the more that you get stuck in that mode of overdoing it, the less effective you’re going to be in helping people and also the more likely that you’ll be at risk of perhaps being one of the people that needs help.

It’s also important to make sure you’re staying connected with family and friends virtually, in whatever ways you can safely do that with social distancing.
 

So take a break to watch some Netflix now and then?

Yes!
 

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

The prolonged and unique stresses imparted by the COVID-19 pandemic has many predicting a significant rise in mental health issues in the weeks, months, and years ahead.

To understand how health care workers can best get ahead of this emerging crisis within a crisis, Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Sheila Rauch, PhD, who’s with the Department of Psychiatry and Behavioral Sciences at the Emory University, Atlanta. The director of Mental Health Research and Program Evaluation at the Atlanta VA Medical Center, Dr. Rauch has studied the effects of and best treatments for posttraumatic stress disorder (PTSD) and anxiety disorders over the past 20 years.
 

Are we going to see a PTSD or anxiety epidemic as a result of the pandemic?

First, I think it’s really important that we prepare for the worst but hope for the best. But I would expect that, given the high levels of stress, the impact on resources, and other factors, we are going to see a pretty significant mental health impact over time. This could be the new normal for a while. Some of that will be PTSD, but there will also be other things. I would suspect that the resulting increase in rates of depression, traumatic grief, and loss is probably going to be a significant issue for years to come.

What will the anxiety we see as a result of COVID-19 look like compared with that seen in past disasters, like 9/11?

Most disasters in recent history, like 9/11, are single incidents. Something horrible happened, it impacted people at different levels, and we were able to start putting the pieces back together right away. The prolonged nature of this pandemic makes it even more variable given that the impact is going to be extended over time.

We’re also going to see a lot more people with compound impact – people who’ve lost their jobs, loved ones, maybe even their homes. All of those financial and resource losses put people in a higher risk category for negative mental health outcomes.
 

Is this analogous to the prolonged trauma that can occur with military service during war?

There is some similarity there. Combat is kind of an overarching context in which people experience trauma and, much like this pandemic, may or may not have traumatic exposures during it.

We’re asking health care workers to actually be in a role similar to what we ask of our military: going into danger, sometimes even without proper protective equipment, in order to save the lives of others. That’s also something we need to be factoring in as we plan to support those people and their families.
 

This is an ongoing incident, but is there a time window we need to be particularly worried about for seeing spikes in anxiety and PTSD?

I think we’re going to see variability on that. PTSD is a disorder that’s related to a specific incident or a couple of incidents that are similar. It’s a memory that’s haunting you.

For instance, typically if you have a combat veteran who has PTSD, they’ve been exposed to the overarching context of combat but then they have specific memories that are stuck. If they don’t have PTSD about 3-6 months after those incidents happen, then we would expect that they will not develop it, or it’s much less common that they would.

Depression has a very different course. It’s more prolonged and tends to grow with time.
 

Are you already seeing increased symptoms in your patients?

We’re seeing more anxiety, a lot of frustration, and a lot of very strong feelings about the leadership decisions that are being made. This is pretty similar to what we see in combat veterans. They’ll often be unhappy with the leadership decisions that were made as they were being deployed.

We’re also seeing lots more anger, sadness, and isolation now. Especially over the past couple of weeks, we’ve seen a rise in things like people reaching out for help in our intakes because we’re still open and doing phone assessments and telehealth with veterans and the veterans program.
 

In terms of interventions for this, what should psychiatrists, psychologists, and other clinicians be thinking about?

Right now, the best thing that we can do as mental health providers for people affected by the trauma is provide crisis intervention for those saying they are a danger to themselves and others. That means providing coping strategies and support. It also means making sure people are taking breaks and taking care of themselves, taking that little bit of time off so that they can go back, fully recharged, to their jobs and really stay there.

As we move forward, it will be clearer whether people are going to naturally recover, which most people will. For those who are going to have ongoing problems with time, we need to be getting ready as a system and as a country for those long-term mental health issues that are going to be coming up. And when I say long-term, it means the next 1-3 months. We want to be providing preventive interventions, versions of prolonged exposure, and other things that have shown some help in preventing PTSD. Psychological first aid is helpful.

There’s also an app called COVID Coach that the National Center for PTSD has created. That features a lot of positive coping resources together in one source.

Then when we get to the middle of that point and beyond it, we need to be ready to provide those evidence-based interventions for PTSD, depression, panic disorder, and other issues that are going to come out of this current situation.

But we were already short-staffed as far as mental health resources in general across the country, and especially in rural areas. So that means finding ways to efficiently use what we have through potentially briefer versions of interventions, through primary care, mental health, and other staff.
 

In what ways can primary care providers help?

There are versions of prolonged exposure therapy for primary care. That’s one of my big areas of research – increasing access. That would be something that we need to be building, by training and embedding mental health providers in primary care settings so that they can help to accommodate the increased need for access that’s going to be showing up for the next, I would suspect, several years with the pandemic.

Is there evidence that a prior episode of PTSD or traumatic experience like combat influences a subsequent reaction to a trauma like this?

It depends on how they manage. Research suggests that veterans or other people who have experienced trauma and naturally recovered, or who have gotten good treatment and remitted from that issue, are probably at no higher risk. But people who have subsyndromal PTSD or depression, or who are still experiencing symptoms from a history of trauma exposure, are maybe at a higher risk of having problems over time.

Do you have any guidance for healthcare providers on how to approach the pandemic with their patients, and also on how they can look after their own mental health?

In talking to patients, make sure that they have what they need. Ask if they’ve thought through how they’re going to cope if things get harder for them.

For people who have preexisting mental health issues, I’m talking with them about whether things have gotten worse. If they’re at high risk for suicide, I’m checking in to make sure that they’ve got new plans and ways to connect with people to reduce isolation, keeping in mind the social distancing that we’re asked to engage in so that they can do that safely.

It’s important to check and see if they have had any losses, whether it’s a financial loss or a personal loss of people that they care about. Also have them think through ways to stay entertained, which tends to help manage their own anxiety.

Every coping strategy we outline for patients also applies to mental health professionals. However, you would add to it the real need to take time to recharge, to take breaks, time off. It can feel overwhelming and like you need to just keep going. But the more that you get stuck in that mode of overdoing it, the less effective you’re going to be in helping people and also the more likely that you’ll be at risk of perhaps being one of the people that needs help.

It’s also important to make sure you’re staying connected with family and friends virtually, in whatever ways you can safely do that with social distancing.
 

So take a break to watch some Netflix now and then?

Yes!
 

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

The prolonged and unique stresses imparted by the COVID-19 pandemic has many predicting a significant rise in mental health issues in the weeks, months, and years ahead.

To understand how health care workers can best get ahead of this emerging crisis within a crisis, Medscape Psychiatry editorial director Bret Stetka, MD, spoke with Sheila Rauch, PhD, who’s with the Department of Psychiatry and Behavioral Sciences at the Emory University, Atlanta. The director of Mental Health Research and Program Evaluation at the Atlanta VA Medical Center, Dr. Rauch has studied the effects of and best treatments for posttraumatic stress disorder (PTSD) and anxiety disorders over the past 20 years.
 

Are we going to see a PTSD or anxiety epidemic as a result of the pandemic?

First, I think it’s really important that we prepare for the worst but hope for the best. But I would expect that, given the high levels of stress, the impact on resources, and other factors, we are going to see a pretty significant mental health impact over time. This could be the new normal for a while. Some of that will be PTSD, but there will also be other things. I would suspect that the resulting increase in rates of depression, traumatic grief, and loss is probably going to be a significant issue for years to come.

What will the anxiety we see as a result of COVID-19 look like compared with that seen in past disasters, like 9/11?

Most disasters in recent history, like 9/11, are single incidents. Something horrible happened, it impacted people at different levels, and we were able to start putting the pieces back together right away. The prolonged nature of this pandemic makes it even more variable given that the impact is going to be extended over time.

We’re also going to see a lot more people with compound impact – people who’ve lost their jobs, loved ones, maybe even their homes. All of those financial and resource losses put people in a higher risk category for negative mental health outcomes.
 

Is this analogous to the prolonged trauma that can occur with military service during war?

There is some similarity there. Combat is kind of an overarching context in which people experience trauma and, much like this pandemic, may or may not have traumatic exposures during it.

We’re asking health care workers to actually be in a role similar to what we ask of our military: going into danger, sometimes even without proper protective equipment, in order to save the lives of others. That’s also something we need to be factoring in as we plan to support those people and their families.
 

This is an ongoing incident, but is there a time window we need to be particularly worried about for seeing spikes in anxiety and PTSD?

I think we’re going to see variability on that. PTSD is a disorder that’s related to a specific incident or a couple of incidents that are similar. It’s a memory that’s haunting you.

For instance, typically if you have a combat veteran who has PTSD, they’ve been exposed to the overarching context of combat but then they have specific memories that are stuck. If they don’t have PTSD about 3-6 months after those incidents happen, then we would expect that they will not develop it, or it’s much less common that they would.

Depression has a very different course. It’s more prolonged and tends to grow with time.
 

Are you already seeing increased symptoms in your patients?

We’re seeing more anxiety, a lot of frustration, and a lot of very strong feelings about the leadership decisions that are being made. This is pretty similar to what we see in combat veterans. They’ll often be unhappy with the leadership decisions that were made as they were being deployed.

We’re also seeing lots more anger, sadness, and isolation now. Especially over the past couple of weeks, we’ve seen a rise in things like people reaching out for help in our intakes because we’re still open and doing phone assessments and telehealth with veterans and the veterans program.
 

In terms of interventions for this, what should psychiatrists, psychologists, and other clinicians be thinking about?

Right now, the best thing that we can do as mental health providers for people affected by the trauma is provide crisis intervention for those saying they are a danger to themselves and others. That means providing coping strategies and support. It also means making sure people are taking breaks and taking care of themselves, taking that little bit of time off so that they can go back, fully recharged, to their jobs and really stay there.

As we move forward, it will be clearer whether people are going to naturally recover, which most people will. For those who are going to have ongoing problems with time, we need to be getting ready as a system and as a country for those long-term mental health issues that are going to be coming up. And when I say long-term, it means the next 1-3 months. We want to be providing preventive interventions, versions of prolonged exposure, and other things that have shown some help in preventing PTSD. Psychological first aid is helpful.

There’s also an app called COVID Coach that the National Center for PTSD has created. That features a lot of positive coping resources together in one source.

Then when we get to the middle of that point and beyond it, we need to be ready to provide those evidence-based interventions for PTSD, depression, panic disorder, and other issues that are going to come out of this current situation.

But we were already short-staffed as far as mental health resources in general across the country, and especially in rural areas. So that means finding ways to efficiently use what we have through potentially briefer versions of interventions, through primary care, mental health, and other staff.
 

In what ways can primary care providers help?

There are versions of prolonged exposure therapy for primary care. That’s one of my big areas of research – increasing access. That would be something that we need to be building, by training and embedding mental health providers in primary care settings so that they can help to accommodate the increased need for access that’s going to be showing up for the next, I would suspect, several years with the pandemic.

Is there evidence that a prior episode of PTSD or traumatic experience like combat influences a subsequent reaction to a trauma like this?

It depends on how they manage. Research suggests that veterans or other people who have experienced trauma and naturally recovered, or who have gotten good treatment and remitted from that issue, are probably at no higher risk. But people who have subsyndromal PTSD or depression, or who are still experiencing symptoms from a history of trauma exposure, are maybe at a higher risk of having problems over time.

Do you have any guidance for healthcare providers on how to approach the pandemic with their patients, and also on how they can look after their own mental health?

In talking to patients, make sure that they have what they need. Ask if they’ve thought through how they’re going to cope if things get harder for them.

For people who have preexisting mental health issues, I’m talking with them about whether things have gotten worse. If they’re at high risk for suicide, I’m checking in to make sure that they’ve got new plans and ways to connect with people to reduce isolation, keeping in mind the social distancing that we’re asked to engage in so that they can do that safely.

It’s important to check and see if they have had any losses, whether it’s a financial loss or a personal loss of people that they care about. Also have them think through ways to stay entertained, which tends to help manage their own anxiety.

Every coping strategy we outline for patients also applies to mental health professionals. However, you would add to it the real need to take time to recharge, to take breaks, time off. It can feel overwhelming and like you need to just keep going. But the more that you get stuck in that mode of overdoing it, the less effective you’re going to be in helping people and also the more likely that you’ll be at risk of perhaps being one of the people that needs help.

It’s also important to make sure you’re staying connected with family and friends virtually, in whatever ways you can safely do that with social distancing.
 

So take a break to watch some Netflix now and then?

Yes!
 

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

COVID-19 patients treated in intensive care units are at increased risk for delirium, and a bedside risk management strategy based on modifiable risk factors can help prevent lingering effects on cognition, according to an article published in Critical Care.

Andrei Malov/Thinkstock

Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.

“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.

Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.

In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.

“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.

The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.

“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.

As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.

The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.

They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.

“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.

“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.

“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.

“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.

“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.

For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”

Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.

Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.

The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.

SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.

COVID-19 patients treated in intensive care units are at increased risk for delirium, and a bedside risk management strategy based on modifiable risk factors can help prevent lingering effects on cognition, according to an article published in Critical Care.

Andrei Malov/Thinkstock

Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.

“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.

Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.

In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.

“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.

The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.

“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.

As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.

The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.

They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.

“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.

“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.

“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.

“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.

“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.

For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”

Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.

Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.

The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.

SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.

COVID-19 patients treated in intensive care units are at increased risk for delirium, and a bedside risk management strategy based on modifiable risk factors can help prevent lingering effects on cognition, according to an article published in Critical Care.

Andrei Malov/Thinkstock

Several factors can contribute to an increased risk of ICU delirium in COVID-19 patients, wrote Katarzyna Kotfis, MD, of Pomeranian Medical University, Szczecin, Poland, and colleagues.

“In patients with COVID-19, delirium may be a manifestation of direct central nervous system invasion, induction of CNS inflammatory mediators, a secondary effect of other organ system failure, an effect of sedative strategies, prolonged mechanical ventilation time, or environmental factors, including social isolation,” they said.

Delirium in the context of COVID-19 can mean an early sign of infection, so patients should be screened using dedicated psychometric tools, the researchers wrote. Also, COVID-19 has been shown to cause pneumonia in elderly patients, who are at high risk for severe pulmonary disease related to COVID-19 and for ICU delirium generally, they said.

In addition, don’t underestimate the impact of social isolation created by quarantines, the researchers said.

“What is needed now, is not only high-quality ICU care, concentrated on providing adequate respiratory support to critically ill patients, but an identification of the source and degree of mental and spiritual suffering of patients as well as their families to provide the most ethical and person-centered care during this humanitarian crisis,” they emphasized. However, they acknowledged that nonpharmacologic interventions such as mobility outside the ICU room and interactions with family members are limited by the COVID-19 situation.

The researchers noted several mechanisms by which the COVID-19 virus may cause brain damage, including through the dysfunction of the renin-angiotensin system.

“Inflammatory response of the CNS to viral infection seems to be another important reason for poor neurological outcome and occurrence of delirium,” in COVID-19 patients, they said.

As for risk-reduction strategies, the researchers noted that “delirium in mechanically ventilated patients can be reduced dramatically to 50% using a culture of lighter sedation and mobilization via the implementation of the safety bundle called the ABCDEFs promoted by the Society of Critical Care Medicine in their ICU Liberation Collaborative,” although COVID-19 isolation is a barrier, they said.

The ABCDEF bundle consists of Assessment of pain, Both spontaneous awakening trials and spontaneous breathing trials, Choice of sedation, Delirium (hyperactive or hypoactive), Early mobility, and Family presence; all of which are challenging in the COVID-19 environment, the researchers said.

They advised implementing easy screening methods for delirium to reduce the burden on medical staff, and emphasized the importance of regular patient orientation, despite social separation from family and caregivers.

“No drugs can be recommended for the prevention or treatment of ICU delirium other than avoidance of overuse of potent psychoactive agents like sedatives and neuromuscular blockers (NMB) unless patients absolutely require such management,” they added.

“Delirium is so common and so hard to manage in the COVID-19 population,” Mangala Narasimhan, DO, of Northwell Health in New Hyde Park, N.Y., said in an interview. Delirium is impacted by many sources including a viral encephalopathy, the amount and duration of sedation medications, and prolonged intubation and hypoxemia, she said. “Managing the delirium allows you to wake the patient up successfully and without a lot of discoordination. This will help with weaning,” she noted. Barriers to delirium management for COVID-19 patients include the length of time on a ventilator, as well as amount of sedatives and paralytics, and the added issues of renal insufficiency, she noted. “How they can be addressed is thoughtful plans on the addition of long-term sedation for withdrawal symptoms, and anxiolytics for the profound anxiety associated with arousal from this type of sedation on ventilators, she said. The take-home message for clinicians is the need to perform weaning trials to manage delirium in the ICU. “We have to combat this delirium in order to be successful in taking these patients off of ventilators,” she said. Dr. Narasimhan added that more research is needed on areas including drug-to-drug interactions, duration of efficacy of various drugs, and how the virus affects the brain.

“Adherence to the ABCDEF bundle can reduce the incidence of delirium, from approximately 75% of mechanically ventilated patients to 50% or less,” David L. Bowton, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., said in an interview.

“Importantly, in most studies, bundle adherence reduces mortality and ICU length of stay and lowers the total cost of care. However, isolation of patients and protection of staff, visitor restrictions, and potentially stressed staffing will likely alter how most institutions approach bundle compliance,” he said. “Gathering input from infection control clinicians and bedside providers from multiple disciplines that consider these factors to critically examine current bundle procedures and workflow will be essential to the creation and/or revision of bundle processes of care that maintain the integrity of the ABCDEF bundle yet preserve staff, patient, and family safety,” he said.

“We did not have strong evidence to suggest an optimal approach to treating delirium before the advent of the COVID-19 pandemic, so I do not believe we know what the best approach is in the current environment,” Dr. Bowton added. “Further, vigilance will be necessary to ensure that altered consciousness or cognition is ICU delirium and not attributable to another cause such as drug withdrawal, drug adverse effect, or primary central nervous system infection or immune response that mandates specific therapy,” he emphasized.

For clinicians, “this study reminds us of the importance of the ABCDEF bundle to improve outcomes of critical illness,” said Dr. Bowton. “It highlights the difficulties of providing frequent reassessment of pain, comfort, reassurance, and reorientation to critically ill patients. To me, it underscores the importance of each institution critically examining staffing needs and staffing roles to mitigate these difficulties and to explore novel methods of maintaining staff-patient and family-patient interactions to enhance compliance with all elements of the ABCDEF bundle while maintaining the safety of staff and families.”

Dr. Bowton added, “When necessary, explicit modifications to existing ABCDEF bundles should be developed and disseminated to provide realistic, readily understood guidance to achieve the best possible compliance with each bundle element. One potentially underrecognized issue will be the large, hopefully temporary, number of people requiring post–critical illness rehabilitation and mental health services,” he said. “In many regions these services are already underfunded and ill-equipped to handle an increased demand for these services,” he noted.

Additional research is needed in many areas, said Dr. Bowton. “While compliance with the ABCDEF bundle decreases the incidence and duration of delirium, decreases ICU length of stay, decreases duration of mechanical ventilation, and improves mortality, many questions remain. Individual elements of the bundle have been inconsistently associated with improved outcomes,” he said. “What is the relative importance of specific elements and what are the mechanisms by which they improve outcomes?” he asked. “We still do not know how to best achieve physical/functional recovery following critical illness, which, in light of these authors’ studies relating persisting physical debility to depression (Lancet Respir Med. 2014; 2[5]:369-79), may be a key component to improving long-term outcomes,” he said.

The study received no specific funding, although several coauthors disclosed grants from agencies including the National Center for Advancing Translational Sciences, National Institute of General Medical Sciences, National Heart, Lung, and Blood Institute, and National Institute on Aging. Dr. Narasimhan and Dr. Bowton had no financial conflicts to disclose.

SOURCE: Kotfis K et al. Critical Care. 2020 Apr 28. doi: 10.1186/s13054-020-02882-x.

Manufacturers will begin producing COVID-19 vaccine doses in anticipation of approval so that if a product gets the okay for usage, distribution can begin quickly, according to Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

Steve Mann/Thinkstock

“We will be producing vaccine at risk, which means we’ll be [investing] considerable resources in developing doses even before we know any given candidate or candidates work,” he testified during a May 12, 2020, hearing of the Senate Health, Education, Labor, and Pensions Committee.

During the hearing, Dr. Fauci did not elaborate on how the production at risk would be undertaken, what criteria would be in place for selecting which candidates would be in the pipeline, or how much would be spent on the advanced production of these vaccines.

And while Dr. Fauci, a member of the White House coronavirus task force, remained optimistic that one or more vaccine candidates would ultimately be viable, he cautioned that there remain many unknowns that could slow the development of a vaccine for COVID-19.

“I must warn that there’s also the possibility of negative consequences that certain vaccines can actually enhance the negative effect of the infection,” he said. “The big unknown is efficacy. Will it be present or absent and how durable will it be?”

It’s unlikely that either a vaccine or an effective treatment will be available in the next 3 months, Dr. Fauci told the committee.

Sen. Lamar Alexander (R-Tenn.), the committee chairman, asked Dr. Fauci what he would say to college, primary, and secondary school administrators about how the availability of treatments and vaccines could influence the ability to reopen campuses to students. Dr. Fauci replied that the idea of having treatments or a vaccine available to facilitate the reentry of students in the fall term would be “a bit of a bridge too far.”

The emphasis in the coming months should be on testing, contact tracing, and isolation of those infected with the virus, Dr. Fauci said.

[email protected]

Manufacturers will begin producing COVID-19 vaccine doses in anticipation of approval so that if a product gets the okay for usage, distribution can begin quickly, according to Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

Steve Mann/Thinkstock

“We will be producing vaccine at risk, which means we’ll be [investing] considerable resources in developing doses even before we know any given candidate or candidates work,” he testified during a May 12, 2020, hearing of the Senate Health, Education, Labor, and Pensions Committee.

During the hearing, Dr. Fauci did not elaborate on how the production at risk would be undertaken, what criteria would be in place for selecting which candidates would be in the pipeline, or how much would be spent on the advanced production of these vaccines.

And while Dr. Fauci, a member of the White House coronavirus task force, remained optimistic that one or more vaccine candidates would ultimately be viable, he cautioned that there remain many unknowns that could slow the development of a vaccine for COVID-19.

“I must warn that there’s also the possibility of negative consequences that certain vaccines can actually enhance the negative effect of the infection,” he said. “The big unknown is efficacy. Will it be present or absent and how durable will it be?”

It’s unlikely that either a vaccine or an effective treatment will be available in the next 3 months, Dr. Fauci told the committee.

Sen. Lamar Alexander (R-Tenn.), the committee chairman, asked Dr. Fauci what he would say to college, primary, and secondary school administrators about how the availability of treatments and vaccines could influence the ability to reopen campuses to students. Dr. Fauci replied that the idea of having treatments or a vaccine available to facilitate the reentry of students in the fall term would be “a bit of a bridge too far.”

The emphasis in the coming months should be on testing, contact tracing, and isolation of those infected with the virus, Dr. Fauci said.

[email protected]

Manufacturers will begin producing COVID-19 vaccine doses in anticipation of approval so that if a product gets the okay for usage, distribution can begin quickly, according to Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

Steve Mann/Thinkstock

“We will be producing vaccine at risk, which means we’ll be [investing] considerable resources in developing doses even before we know any given candidate or candidates work,” he testified during a May 12, 2020, hearing of the Senate Health, Education, Labor, and Pensions Committee.

During the hearing, Dr. Fauci did not elaborate on how the production at risk would be undertaken, what criteria would be in place for selecting which candidates would be in the pipeline, or how much would be spent on the advanced production of these vaccines.

And while Dr. Fauci, a member of the White House coronavirus task force, remained optimistic that one or more vaccine candidates would ultimately be viable, he cautioned that there remain many unknowns that could slow the development of a vaccine for COVID-19.

“I must warn that there’s also the possibility of negative consequences that certain vaccines can actually enhance the negative effect of the infection,” he said. “The big unknown is efficacy. Will it be present or absent and how durable will it be?”

It’s unlikely that either a vaccine or an effective treatment will be available in the next 3 months, Dr. Fauci told the committee.

Sen. Lamar Alexander (R-Tenn.), the committee chairman, asked Dr. Fauci what he would say to college, primary, and secondary school administrators about how the availability of treatments and vaccines could influence the ability to reopen campuses to students. Dr. Fauci replied that the idea of having treatments or a vaccine available to facilitate the reentry of students in the fall term would be “a bit of a bridge too far.”

The emphasis in the coming months should be on testing, contact tracing, and isolation of those infected with the virus, Dr. Fauci said.

[email protected]