The American Society of Hematology has committed a portion of its website to providing continually updated information addressing specific hematologic disorders in relation to COVID-19.

“As the world grapples with the novel coronavirus, ASH believes that we can help each other be as knowledgeable and prepared as possible,” wrote the society’s president, Stephanie J. Lee, MD, MPH.

On its website, ASH provides relevant COVID-19 information in a series of FAQ divided into malignant and nonmalignant hematologic diseases and disorders. In the malignant category, the various lymphomas and leukemias are individually addressed, as well as other conditions such as myelodysplastic syndromes, myeloproliferative neoplasms, and multiple myeloma. In the nonmalignant category, ASH has provided FAQ on aplastic anemia, thalassemia, sickle cell disease, pulmonary embolism, venous thromboembolism/anticoagulation, coagulopathy, and immune as well as thrombotic thrombocytopenic purpura.

In addition to the continually updated series of relevant FAQ, as part of its response to the pandemic ASH is promoting two unique COVID-19 registries for physicians: the ASH Research Collaborative’s (ASH RC) Data Hub COVID-19 Registry and the Surveillance Epidemiology of Coronavirus (COVID-19) Under Research Exclusion Sickle Cell Disease (SECURE-SCD) Registry.

“The ASH Research Collaborative’s (ASH RC) Data Hub launched the COVID-19 Registry and is currently capturing data on people who test positive for COVID-19 and have been or are currently being treated for hematologic malignancy,” according to the website. The intention is to provide “near real-time observational data summaries,” which will hopefully provide useful information to clinicians treating hematologic malignancies in patients in the midst of the COVID-19 pandemic.

The registry allows clinicians to enter their own cases in a specified format to allow data analysis on clinical practice and patient outcomes that will be aggregated to provide rapid insights for clinicians to help them care for their patients, according to ASH.

The second registry specifically deals with COVID-19 cases in patients with sickle cell disease. It also allows clinicians to add cases with a similar intention of aggregating data to provide near real-time insights into patient care. “We are asking providers caring for these patients to report all of their cases of COVID-19 to this registry,” according to the registry website. The registry is for reporting COVID-19 cases in sickle cell disease patients “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”

ASH also provides more generalized information for hematology practitioners dealing with COVID-19 on the topics of conducting their practice and using telemedicine, among others.

Correction, April 15, 2020: This story originally said incorrectly that ASH developed the 2 new registries. The registries are merely being promoted on the ASH website.

mlesney@mdedge.com

The American Society of Hematology has committed a portion of its website to providing continually updated information addressing specific hematologic disorders in relation to COVID-19.

“As the world grapples with the novel coronavirus, ASH believes that we can help each other be as knowledgeable and prepared as possible,” wrote the society’s president, Stephanie J. Lee, MD, MPH.

On its website, ASH provides relevant COVID-19 information in a series of FAQ divided into malignant and nonmalignant hematologic diseases and disorders. In the malignant category, the various lymphomas and leukemias are individually addressed, as well as other conditions such as myelodysplastic syndromes, myeloproliferative neoplasms, and multiple myeloma. In the nonmalignant category, ASH has provided FAQ on aplastic anemia, thalassemia, sickle cell disease, pulmonary embolism, venous thromboembolism/anticoagulation, coagulopathy, and immune as well as thrombotic thrombocytopenic purpura.

In addition to the continually updated series of relevant FAQ, as part of its response to the pandemic ASH is promoting two unique COVID-19 registries for physicians: the ASH Research Collaborative’s (ASH RC) Data Hub COVID-19 Registry and the Surveillance Epidemiology of Coronavirus (COVID-19) Under Research Exclusion Sickle Cell Disease (SECURE-SCD) Registry.

“The ASH Research Collaborative’s (ASH RC) Data Hub launched the COVID-19 Registry and is currently capturing data on people who test positive for COVID-19 and have been or are currently being treated for hematologic malignancy,” according to the website. The intention is to provide “near real-time observational data summaries,” which will hopefully provide useful information to clinicians treating hematologic malignancies in patients in the midst of the COVID-19 pandemic.

The registry allows clinicians to enter their own cases in a specified format to allow data analysis on clinical practice and patient outcomes that will be aggregated to provide rapid insights for clinicians to help them care for their patients, according to ASH.

The second registry specifically deals with COVID-19 cases in patients with sickle cell disease. It also allows clinicians to add cases with a similar intention of aggregating data to provide near real-time insights into patient care. “We are asking providers caring for these patients to report all of their cases of COVID-19 to this registry,” according to the registry website. The registry is for reporting COVID-19 cases in sickle cell disease patients “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”

ASH also provides more generalized information for hematology practitioners dealing with COVID-19 on the topics of conducting their practice and using telemedicine, among others.

Correction, April 15, 2020: This story originally said incorrectly that ASH developed the 2 new registries. The registries are merely being promoted on the ASH website.

mlesney@mdedge.com

The American Society of Hematology has committed a portion of its website to providing continually updated information addressing specific hematologic disorders in relation to COVID-19.

“As the world grapples with the novel coronavirus, ASH believes that we can help each other be as knowledgeable and prepared as possible,” wrote the society’s president, Stephanie J. Lee, MD, MPH.

On its website, ASH provides relevant COVID-19 information in a series of FAQ divided into malignant and nonmalignant hematologic diseases and disorders. In the malignant category, the various lymphomas and leukemias are individually addressed, as well as other conditions such as myelodysplastic syndromes, myeloproliferative neoplasms, and multiple myeloma. In the nonmalignant category, ASH has provided FAQ on aplastic anemia, thalassemia, sickle cell disease, pulmonary embolism, venous thromboembolism/anticoagulation, coagulopathy, and immune as well as thrombotic thrombocytopenic purpura.

In addition to the continually updated series of relevant FAQ, as part of its response to the pandemic ASH is promoting two unique COVID-19 registries for physicians: the ASH Research Collaborative’s (ASH RC) Data Hub COVID-19 Registry and the Surveillance Epidemiology of Coronavirus (COVID-19) Under Research Exclusion Sickle Cell Disease (SECURE-SCD) Registry.

“The ASH Research Collaborative’s (ASH RC) Data Hub launched the COVID-19 Registry and is currently capturing data on people who test positive for COVID-19 and have been or are currently being treated for hematologic malignancy,” according to the website. The intention is to provide “near real-time observational data summaries,” which will hopefully provide useful information to clinicians treating hematologic malignancies in patients in the midst of the COVID-19 pandemic.

The registry allows clinicians to enter their own cases in a specified format to allow data analysis on clinical practice and patient outcomes that will be aggregated to provide rapid insights for clinicians to help them care for their patients, according to ASH.

The second registry specifically deals with COVID-19 cases in patients with sickle cell disease. It also allows clinicians to add cases with a similar intention of aggregating data to provide near real-time insights into patient care. “We are asking providers caring for these patients to report all of their cases of COVID-19 to this registry,” according to the registry website. The registry is for reporting COVID-19 cases in sickle cell disease patients “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”

ASH also provides more generalized information for hematology practitioners dealing with COVID-19 on the topics of conducting their practice and using telemedicine, among others.

Correction, April 15, 2020: This story originally said incorrectly that ASH developed the 2 new registries. The registries are merely being promoted on the ASH website.

mlesney@mdedge.com

Establish a Command Team

We benefit from having an existing divisional leadership structure comprising the director, medical directors of our clinical service lines, directors of education and community integration, and associate directors of clinical operations, research, and quality. This established team provides us broad representation of team member expertise and ideas. We maintain our weekly leadership team meeting through video chat and have added daily 30-minute virtual huddles to provide updates from our respective areas and discuss logistical challenges and planning. We use ad hoc phone meetings with relevant team members to address issues of immediate concern.

In the absence of a formal leadership team structure, establish a command team comprising representative leaders of your varied groups (eg, clinical operations, quality improvement, education, research, and business).

Collaborate With Institutional Response

Align divisional command team actions with the institutional response. Our clinical operations leader serves as our primary representative on the institutional emergency preparedness team. This participation allows bidirectional communication, both for institutional updates to be shared with division members and division-specific initiatives to be shared with institutional leadership to facilitate learning across the system.

In conjunction with hospital leadership, our division created a special isolation unit (SIU) to isolate patients positive for COVID-19 and persons under investigation. The institutional emergency preparedness team highlighted the need for such a unit, and our divisional leadership team developed the physician staffing model and medical care delivery system. We collaborated with key stakeholders, including nurses, respiratory therapists, other patient care services members, and subspecialists. The SIU leadership, which includes representatives from hospital medicine, nursing, respiratory therapy, and hospital operations, holds regular phone huddles to provide support and enlist resources based on identified gaps, which allows the frontline SIU physicians to focus on patient care. The calls initially occurred twice daily, but we transitioned to a once-daily schedule after routines were established and resources were procured.

Communicate With Everyone

Frequent communication with the clinical staff is paramount given the rapidly evolving operational changes and medical management recommendations. The divisional leadership team provides frequent email updates to the attending physicians on clinical shifts to communicate clinical updates, send reminders to conserve personal protective equipment (PPE), and share links to COVID-19 resources.

We use our weekly divisional meetings, now held virtually, to provide updates and to allow staff to ask questions and provide input. These meetings routinely include our nonclinical staff, such as administrative assistants and research coordinators, to ensure all team members’ voices are heard and skill sets are utilized. Our divisional infrastructure promotes dialogue and transparency, which is key to our division’s culture. Applying a learning health network approach has allowed us to generate new ideas, accelerate improvement, and encourage everyone to be a part of our community focused on improving outcomes.⁶ We continue to leverage this approach in our pandemic response.

One idea generated from this approach prompted us to create a centralized communication forum, using Microsoft Teams, to serve as a repository for the most up-to-date information related to COVID-19, the SIU, and general information, including links to divisional and institutional resources.

Maintain Nonclinical Operations

Nonclinical staff are working remotely. The business director and research director hold daily calls with the administrative staff and research coordinators, respectively, to discuss workload and to reallocate responsibilities as needed. This approach allows the business, administrative, and research support teams to function efficiently and redistribute work as the nonclinical priorities shift to meet divisional needs.

Establish a Backup Pool

We anticipate needing a larger pool of backup providers in the event of ill or quarantined staff or in case of increased patient volumes. The latter may be less likely for pediatric patients based on early studies^3-5 but could occur if our free-standing children’s hospital expands to include the care of adult patients. We asked physicians to volunteer for backup shifts to augment our existing “jeopardy” backup system with a greater request to those with a lower clinical full-time equivalence. Each day, two backup shift positions are filled by volunteers, with additional positions added on days when medicine-­pediatrics providers are scheduled for shifts in case they are needed at the university (adult) hospital.

Minimize Staffing to Reserve Pool

We monitor census closely on all service lines, including our consult service lines and secondary inpatient site, with plans to dissolve unnecessary consult services and combine medical teams, when feasible, to reduce the risk of staff exposure and maintain reserves. For example, after elective procedures were canceled, we reduced physician staffing of our surgical comanagement service to the minimal necessary coverage. We assign nonpatient-facing clinical duties to physicians who are called off their shift, in quarantine, or mildly ill to help off-load the clinical burden. Such duties include accepting direct admission phone calls, triaging patient care calls, entering orders remotely, and assisting with care coordination needs.

Anticipate Adult Care Needs

Our pediatric institution admits select groups of adult patients with congenital or complex healthcare needs who require specialized care. Hospitalists board certified in both pediatrics and internal medicine provide consultative services to many of these patients. Anticipating that these physicians may be needed in adult facilities, we plan to dissolve this consult service and utilize our reserve pool of providers to cover their pediatric shifts if needed. Additionally, if our hospital expands coverage for adult patients, these medicine-pediatrics providers will be instrumental in coordinating that expanded effort and will serve as leaders for teams of physicians and advanced practice providers with limited or no adult medicine training.

Special Isolation Unit

Logistic planning for our SIU evolved over the first few patients with rapid-cycle feedback and learning with each admission. This feedback was facilitated with our twice-daily huddle calls, which involved all key stakeholders, including nursing and respiratory therapy representatives. For division physician staffing, higher-risk team members are excluded from working on this unit. Because the SIU was developed to care for all patients positive for COVID-19 and persons under investigation, subspecialty patients not typically cared for by Hospital Medicine at our institution are being admitted to this unit. Therefore, subspecialty divisions assign attending physicians to provide consultative services to the SIU. These consultants use the unit’s telemedicine capabilities, when feasible, to limit staff exposure and conserve PPE. Our hospital medicine leaders in the SIU proactively worked with subspecialty divisions that are anticipated to have more admissions given their at-risk patient populations, such as pulmonary medicine, cardiology, and oncology. They specifically developed staffing plans for these patients if the SIU census becomes unsustainable under Hospital Medicine alone.

Healthcare workers are experiencing numerous stressors at work and home during this tumultuous time. Our workforce is at risk of developing emotional distress and mental health concerns. A cross-sectional survey of more than 1,200 healthcare workers in China who cared for COVID-19 patients found that many experienced symptoms of psychological distress (71%), as well as depression (51%), anxiety (44%), and insomnia (34%).⁷ Hospital medicine groups should consider methods to support their staff to mitigate stressors and promote self-care.

Anticipate Childcare Issues

When we were faced with impending school and daycare closures, we surveyed our division to assess childcare needs (Table) and share resources. We created a system of emergency childcare coverage options by connecting parents with similarly aged children and who lived in geographic proximity. This approach to childcare contingency planning was shared with and adopted by other divisions within the institution.

Build Support Measures

To support each other during this particularly stressful time, we divided division members into groups or “support pods,” each facilitated by a leadership team member. Group text messages and weekly phone or video chats have promoted connectivity and peer support.

Promote Self-care

The divisional leadership team provides food and drink for staff on clinical shifts. We also collated self-care resources to share via a central repository. These resources include ideas for meditation, home education for children, parenting, exercise, faith communities, entertainment, methods to support our local community through volunteerism and donations, and mental health resources, as well as online links to these resources.

Adult health systems will be disproportionately affected as this pandemic evolves. Pediatric hospitalists have the unique opportunity to support the response efforts by maintaining teams that are flexible and adaptable to evolving community needs. To do this, team leaders need to promote transparency, share learnings, and leverage the diverse skills of team members to ensure we are ready to meet the challenges of the moment.

Establish a Command Team

We benefit from having an existing divisional leadership structure comprising the director, medical directors of our clinical service lines, directors of education and community integration, and associate directors of clinical operations, research, and quality. This established team provides us broad representation of team member expertise and ideas. We maintain our weekly leadership team meeting through video chat and have added daily 30-minute virtual huddles to provide updates from our respective areas and discuss logistical challenges and planning. We use ad hoc phone meetings with relevant team members to address issues of immediate concern.

In the absence of a formal leadership team structure, establish a command team comprising representative leaders of your varied groups (eg, clinical operations, quality improvement, education, research, and business).

Collaborate With Institutional Response

Align divisional command team actions with the institutional response. Our clinical operations leader serves as our primary representative on the institutional emergency preparedness team. This participation allows bidirectional communication, both for institutional updates to be shared with division members and division-specific initiatives to be shared with institutional leadership to facilitate learning across the system.

In conjunction with hospital leadership, our division created a special isolation unit (SIU) to isolate patients positive for COVID-19 and persons under investigation. The institutional emergency preparedness team highlighted the need for such a unit, and our divisional leadership team developed the physician staffing model and medical care delivery system. We collaborated with key stakeholders, including nurses, respiratory therapists, other patient care services members, and subspecialists. The SIU leadership, which includes representatives from hospital medicine, nursing, respiratory therapy, and hospital operations, holds regular phone huddles to provide support and enlist resources based on identified gaps, which allows the frontline SIU physicians to focus on patient care. The calls initially occurred twice daily, but we transitioned to a once-daily schedule after routines were established and resources were procured.

Communicate With Everyone

Frequent communication with the clinical staff is paramount given the rapidly evolving operational changes and medical management recommendations. The divisional leadership team provides frequent email updates to the attending physicians on clinical shifts to communicate clinical updates, send reminders to conserve personal protective equipment (PPE), and share links to COVID-19 resources.

We use our weekly divisional meetings, now held virtually, to provide updates and to allow staff to ask questions and provide input. These meetings routinely include our nonclinical staff, such as administrative assistants and research coordinators, to ensure all team members’ voices are heard and skill sets are utilized. Our divisional infrastructure promotes dialogue and transparency, which is key to our division’s culture. Applying a learning health network approach has allowed us to generate new ideas, accelerate improvement, and encourage everyone to be a part of our community focused on improving outcomes.⁶ We continue to leverage this approach in our pandemic response.

One idea generated from this approach prompted us to create a centralized communication forum, using Microsoft Teams, to serve as a repository for the most up-to-date information related to COVID-19, the SIU, and general information, including links to divisional and institutional resources.

Maintain Nonclinical Operations

Nonclinical staff are working remotely. The business director and research director hold daily calls with the administrative staff and research coordinators, respectively, to discuss workload and to reallocate responsibilities as needed. This approach allows the business, administrative, and research support teams to function efficiently and redistribute work as the nonclinical priorities shift to meet divisional needs.

Establish a Backup Pool

We anticipate needing a larger pool of backup providers in the event of ill or quarantined staff or in case of increased patient volumes. The latter may be less likely for pediatric patients based on early studies^3-5 but could occur if our free-standing children’s hospital expands to include the care of adult patients. We asked physicians to volunteer for backup shifts to augment our existing “jeopardy” backup system with a greater request to those with a lower clinical full-time equivalence. Each day, two backup shift positions are filled by volunteers, with additional positions added on days when medicine-­pediatrics providers are scheduled for shifts in case they are needed at the university (adult) hospital.

Minimize Staffing to Reserve Pool

We monitor census closely on all service lines, including our consult service lines and secondary inpatient site, with plans to dissolve unnecessary consult services and combine medical teams, when feasible, to reduce the risk of staff exposure and maintain reserves. For example, after elective procedures were canceled, we reduced physician staffing of our surgical comanagement service to the minimal necessary coverage. We assign nonpatient-facing clinical duties to physicians who are called off their shift, in quarantine, or mildly ill to help off-load the clinical burden. Such duties include accepting direct admission phone calls, triaging patient care calls, entering orders remotely, and assisting with care coordination needs.

Anticipate Adult Care Needs

Our pediatric institution admits select groups of adult patients with congenital or complex healthcare needs who require specialized care. Hospitalists board certified in both pediatrics and internal medicine provide consultative services to many of these patients. Anticipating that these physicians may be needed in adult facilities, we plan to dissolve this consult service and utilize our reserve pool of providers to cover their pediatric shifts if needed. Additionally, if our hospital expands coverage for adult patients, these medicine-pediatrics providers will be instrumental in coordinating that expanded effort and will serve as leaders for teams of physicians and advanced practice providers with limited or no adult medicine training.

Special Isolation Unit

Logistic planning for our SIU evolved over the first few patients with rapid-cycle feedback and learning with each admission. This feedback was facilitated with our twice-daily huddle calls, which involved all key stakeholders, including nursing and respiratory therapy representatives. For division physician staffing, higher-risk team members are excluded from working on this unit. Because the SIU was developed to care for all patients positive for COVID-19 and persons under investigation, subspecialty patients not typically cared for by Hospital Medicine at our institution are being admitted to this unit. Therefore, subspecialty divisions assign attending physicians to provide consultative services to the SIU. These consultants use the unit’s telemedicine capabilities, when feasible, to limit staff exposure and conserve PPE. Our hospital medicine leaders in the SIU proactively worked with subspecialty divisions that are anticipated to have more admissions given their at-risk patient populations, such as pulmonary medicine, cardiology, and oncology. They specifically developed staffing plans for these patients if the SIU census becomes unsustainable under Hospital Medicine alone.

Healthcare workers are experiencing numerous stressors at work and home during this tumultuous time. Our workforce is at risk of developing emotional distress and mental health concerns. A cross-sectional survey of more than 1,200 healthcare workers in China who cared for COVID-19 patients found that many experienced symptoms of psychological distress (71%), as well as depression (51%), anxiety (44%), and insomnia (34%).⁷ Hospital medicine groups should consider methods to support their staff to mitigate stressors and promote self-care.

Anticipate Childcare Issues

When we were faced with impending school and daycare closures, we surveyed our division to assess childcare needs (Table) and share resources. We created a system of emergency childcare coverage options by connecting parents with similarly aged children and who lived in geographic proximity. This approach to childcare contingency planning was shared with and adopted by other divisions within the institution.

Build Support Measures

To support each other during this particularly stressful time, we divided division members into groups or “support pods,” each facilitated by a leadership team member. Group text messages and weekly phone or video chats have promoted connectivity and peer support.

Promote Self-care

The divisional leadership team provides food and drink for staff on clinical shifts. We also collated self-care resources to share via a central repository. These resources include ideas for meditation, home education for children, parenting, exercise, faith communities, entertainment, methods to support our local community through volunteerism and donations, and mental health resources, as well as online links to these resources.

Adult health systems will be disproportionately affected as this pandemic evolves. Pediatric hospitalists have the unique opportunity to support the response efforts by maintaining teams that are flexible and adaptable to evolving community needs. To do this, team leaders need to promote transparency, share learnings, and leverage the diverse skills of team members to ensure we are ready to meet the challenges of the moment.

Establish a Command Team

We benefit from having an existing divisional leadership structure comprising the director, medical directors of our clinical service lines, directors of education and community integration, and associate directors of clinical operations, research, and quality. This established team provides us broad representation of team member expertise and ideas. We maintain our weekly leadership team meeting through video chat and have added daily 30-minute virtual huddles to provide updates from our respective areas and discuss logistical challenges and planning. We use ad hoc phone meetings with relevant team members to address issues of immediate concern.

In the absence of a formal leadership team structure, establish a command team comprising representative leaders of your varied groups (eg, clinical operations, quality improvement, education, research, and business).

Collaborate With Institutional Response

Align divisional command team actions with the institutional response. Our clinical operations leader serves as our primary representative on the institutional emergency preparedness team. This participation allows bidirectional communication, both for institutional updates to be shared with division members and division-specific initiatives to be shared with institutional leadership to facilitate learning across the system.

In conjunction with hospital leadership, our division created a special isolation unit (SIU) to isolate patients positive for COVID-19 and persons under investigation. The institutional emergency preparedness team highlighted the need for such a unit, and our divisional leadership team developed the physician staffing model and medical care delivery system. We collaborated with key stakeholders, including nurses, respiratory therapists, other patient care services members, and subspecialists. The SIU leadership, which includes representatives from hospital medicine, nursing, respiratory therapy, and hospital operations, holds regular phone huddles to provide support and enlist resources based on identified gaps, which allows the frontline SIU physicians to focus on patient care. The calls initially occurred twice daily, but we transitioned to a once-daily schedule after routines were established and resources were procured.

Communicate With Everyone

Frequent communication with the clinical staff is paramount given the rapidly evolving operational changes and medical management recommendations. The divisional leadership team provides frequent email updates to the attending physicians on clinical shifts to communicate clinical updates, send reminders to conserve personal protective equipment (PPE), and share links to COVID-19 resources.

We use our weekly divisional meetings, now held virtually, to provide updates and to allow staff to ask questions and provide input. These meetings routinely include our nonclinical staff, such as administrative assistants and research coordinators, to ensure all team members’ voices are heard and skill sets are utilized. Our divisional infrastructure promotes dialogue and transparency, which is key to our division’s culture. Applying a learning health network approach has allowed us to generate new ideas, accelerate improvement, and encourage everyone to be a part of our community focused on improving outcomes.⁶ We continue to leverage this approach in our pandemic response.

One idea generated from this approach prompted us to create a centralized communication forum, using Microsoft Teams, to serve as a repository for the most up-to-date information related to COVID-19, the SIU, and general information, including links to divisional and institutional resources.

Maintain Nonclinical Operations

Nonclinical staff are working remotely. The business director and research director hold daily calls with the administrative staff and research coordinators, respectively, to discuss workload and to reallocate responsibilities as needed. This approach allows the business, administrative, and research support teams to function efficiently and redistribute work as the nonclinical priorities shift to meet divisional needs.

Establish a Backup Pool

We anticipate needing a larger pool of backup providers in the event of ill or quarantined staff or in case of increased patient volumes. The latter may be less likely for pediatric patients based on early studies^3-5 but could occur if our free-standing children’s hospital expands to include the care of adult patients. We asked physicians to volunteer for backup shifts to augment our existing “jeopardy” backup system with a greater request to those with a lower clinical full-time equivalence. Each day, two backup shift positions are filled by volunteers, with additional positions added on days when medicine-­pediatrics providers are scheduled for shifts in case they are needed at the university (adult) hospital.

Minimize Staffing to Reserve Pool

We monitor census closely on all service lines, including our consult service lines and secondary inpatient site, with plans to dissolve unnecessary consult services and combine medical teams, when feasible, to reduce the risk of staff exposure and maintain reserves. For example, after elective procedures were canceled, we reduced physician staffing of our surgical comanagement service to the minimal necessary coverage. We assign nonpatient-facing clinical duties to physicians who are called off their shift, in quarantine, or mildly ill to help off-load the clinical burden. Such duties include accepting direct admission phone calls, triaging patient care calls, entering orders remotely, and assisting with care coordination needs.

Anticipate Adult Care Needs

Our pediatric institution admits select groups of adult patients with congenital or complex healthcare needs who require specialized care. Hospitalists board certified in both pediatrics and internal medicine provide consultative services to many of these patients. Anticipating that these physicians may be needed in adult facilities, we plan to dissolve this consult service and utilize our reserve pool of providers to cover their pediatric shifts if needed. Additionally, if our hospital expands coverage for adult patients, these medicine-pediatrics providers will be instrumental in coordinating that expanded effort and will serve as leaders for teams of physicians and advanced practice providers with limited or no adult medicine training.

Special Isolation Unit

Logistic planning for our SIU evolved over the first few patients with rapid-cycle feedback and learning with each admission. This feedback was facilitated with our twice-daily huddle calls, which involved all key stakeholders, including nursing and respiratory therapy representatives. For division physician staffing, higher-risk team members are excluded from working on this unit. Because the SIU was developed to care for all patients positive for COVID-19 and persons under investigation, subspecialty patients not typically cared for by Hospital Medicine at our institution are being admitted to this unit. Therefore, subspecialty divisions assign attending physicians to provide consultative services to the SIU. These consultants use the unit’s telemedicine capabilities, when feasible, to limit staff exposure and conserve PPE. Our hospital medicine leaders in the SIU proactively worked with subspecialty divisions that are anticipated to have more admissions given their at-risk patient populations, such as pulmonary medicine, cardiology, and oncology. They specifically developed staffing plans for these patients if the SIU census becomes unsustainable under Hospital Medicine alone.

Healthcare workers are experiencing numerous stressors at work and home during this tumultuous time. Our workforce is at risk of developing emotional distress and mental health concerns. A cross-sectional survey of more than 1,200 healthcare workers in China who cared for COVID-19 patients found that many experienced symptoms of psychological distress (71%), as well as depression (51%), anxiety (44%), and insomnia (34%).⁷ Hospital medicine groups should consider methods to support their staff to mitigate stressors and promote self-care.

Anticipate Childcare Issues

When we were faced with impending school and daycare closures, we surveyed our division to assess childcare needs (Table) and share resources. We created a system of emergency childcare coverage options by connecting parents with similarly aged children and who lived in geographic proximity. This approach to childcare contingency planning was shared with and adopted by other divisions within the institution.

Build Support Measures

To support each other during this particularly stressful time, we divided division members into groups or “support pods,” each facilitated by a leadership team member. Group text messages and weekly phone or video chats have promoted connectivity and peer support.

Promote Self-care

The divisional leadership team provides food and drink for staff on clinical shifts. We also collated self-care resources to share via a central repository. These resources include ideas for meditation, home education for children, parenting, exercise, faith communities, entertainment, methods to support our local community through volunteerism and donations, and mental health resources, as well as online links to these resources.

Adult health systems will be disproportionately affected as this pandemic evolves. Pediatric hospitalists have the unique opportunity to support the response efforts by maintaining teams that are flexible and adaptable to evolving community needs. To do this, team leaders need to promote transparency, share learnings, and leverage the diverse skills of team members to ensure we are ready to meet the challenges of the moment.

On a typical clinic day, Will Bulsiewicz, MD, a Charleston, S.C.–based gastroenterologist, used to see 22 patients, while other days were filled with up to 16 procedures.

Since COVID-19 however, things have vastly changed. Dr. Bulsiewicz now visits with all clinic patients through telehealth, and the volume has dipped to between zero and six patients per day. His three-doctor practice has also experienced a more than 90% reduction in endoscopy volume.

“Naturally, this has been devastating,” Dr. Bulsiewicz said in an interview. “Our practice was started in 1984, and we had a business model that we used for the history of our practice. That practice model was upended in a matter of 2 weeks.”

Dr. Bulsiewicz is far from alone. Community GI practices across the country are experiencing similar financial distress in the face of COVID-19. In addition to a decrease in patient referrals, the Centers for Medicare & Medicaid Services has requested that all elective esophagogastroduodenoscopies, colonoscopies, endoscopies, surgeries, and procedures be delayed during the coronavirus outbreak to conserve critical equipment and limit virus exposure. The guidance aligns with recent recommendations issued by American Gastroenterological Association, American Association for the Study of Liver Diseases, American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy. The lack of patients has led to plummeting revenue for many GI practices and resulted in layoffs, reduced hours, and limited salaries in order to keep practices afloat.

“We’ve had to make drastic changes in the way we work,” said Rajeev Jain, MD, AGAF, a Dallas-based gastroenterologist. “The way private practices are economically set up, they don’t have large reserves of capital or liquidity. We’re not like Apple or these big companies that have these massive cushions. It’s one thing when you have a downturn in the economy and less people come to get care, but when you have a complete shutdown, your revenue stream to pay your bills is literally dried up.”

Dr. Jain’s practice is part of Texas Digestive Disease Consultants (TDDC), which provides GI care for patients in Texas and Louisiana. TDDC is part of GI Alliance, a private equity–based consolidation of practices that includes several states and more than 350 GIs. The management services organization is a collaboration between the PE firm and the partner physicians. Since the COVID-19 outbreak, Dr. Jain said his practice has seen a dramatic drop in patients. Normally, Dr. Jain would perform between 25 and 30 outpatient scopes over the course of 2 days, he said. On a recent Monday, he performed two procedures. To preserve cash flow, Dr. Jain said he and his senior partners are not taking an income right now. Some employees were recently furloughed and laid off.

“I never in my life thought that I would have to lay off people because of an economic issue,” Dr. Jain said. “That’s psychological strain that as a physician owner you feel because these are people that you work with on a day-to-day basis and you don’t want them suffering either. That’s been a tough thing.

James S. Leavitt, MD, said his 17-physician center in Miami, Fla., has furloughed about half its staff. The center is part of Gastro Health, a private equity firm–based medical group with more than 250 providers in four states. Dr. Leavitt, president and chief clinical officer for Gastro Health, said his center has gone from about 150 patients per day to 5 or fewer, while procedures have dropped from more than 100 a day to maybe 5.

Having partnered with a private equity firm, however, Dr. Leavitt believes his practice is bettered situated to manage the health crisis and address financial challenges.

“It’s made us better prepared to weather the storm. We have a very high-powered, sophisticated administration and much broader base and access to capital. [For example,] we had a lot of depth in management so that we could roll out a robust televisit program in a week in four states with over 250 doctors.”

From a business standpoint, however, certain goals for the company are on hold, he said, such as closing on potential acquisitions.

Telemedicine works well for many patients, particularly for follow-up patients and for patients who have an established relationship with Dr. Leavitt, he said. There are limitations of course, he noted.

“If I were a dermatologist, maybe I could see the skin rash, but you can’t examine the patient,” he said. “There are certain things you can’t do. If a patient has significant abdominal pain, a televisit isn’t the greatest.”

That’s why Dr. Leavitt’s care center remains open for the handful of patients who must be seen in-person, he said. Those patients are screened beforehand and their temperatures taken before treatment.

Dr. Bulsiewicz’s practice made the transition to telehealth after never having used the modality before COVID-19.

“This was a scramble,” said Dr. Bulsiewicz, who posts about COVID-19 on social media. “We started from zero knowledge to implementation in less than a week.”

Overall, the switch went smoothly, but Dr. Bulsiewicz said reimbursement challenges come with telehealth.

“The billing is not the same,” he said. “You’re doing the same work or more, and you’re taking a reduced fee because of the antiquated fee structure that is forcing you to apply the typical rules of an office encounter.”

He hopes CMS will alter the reimbursement schedule to temporarily pay on par with traditional evaluation and management codes based on medical complexity as opposed to documentation of physical exam. CMS has already expanded Medicare telehealth coverage to cover a wider range of health care services in light of the COVID-19 crisis and also broadened the range of communication tools that can be used, according to a March announcement.

In the meantime, many practices have applied for financial assistance programs. The AGA recently pushed the government for additional assistance to help struggling practices.

Dr. Jain hopes these assistance programs roll out quickly.

“If these don’t get out there quick enough and big enough, we are going to see a massive wave of loss of independent practices and/or consolidation,” he said. “I fear a death to small, independent practices because they’re not going to have the financial wherewithal to tolerate this for too long.”
 

agallegos@mdedge.com

On a typical clinic day, Will Bulsiewicz, MD, a Charleston, S.C.–based gastroenterologist, used to see 22 patients, while other days were filled with up to 16 procedures.

Since COVID-19 however, things have vastly changed. Dr. Bulsiewicz now visits with all clinic patients through telehealth, and the volume has dipped to between zero and six patients per day. His three-doctor practice has also experienced a more than 90% reduction in endoscopy volume.

“Naturally, this has been devastating,” Dr. Bulsiewicz said in an interview. “Our practice was started in 1984, and we had a business model that we used for the history of our practice. That practice model was upended in a matter of 2 weeks.”

Dr. Bulsiewicz is far from alone. Community GI practices across the country are experiencing similar financial distress in the face of COVID-19. In addition to a decrease in patient referrals, the Centers for Medicare & Medicaid Services has requested that all elective esophagogastroduodenoscopies, colonoscopies, endoscopies, surgeries, and procedures be delayed during the coronavirus outbreak to conserve critical equipment and limit virus exposure. The guidance aligns with recent recommendations issued by American Gastroenterological Association, American Association for the Study of Liver Diseases, American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy. The lack of patients has led to plummeting revenue for many GI practices and resulted in layoffs, reduced hours, and limited salaries in order to keep practices afloat.

“We’ve had to make drastic changes in the way we work,” said Rajeev Jain, MD, AGAF, a Dallas-based gastroenterologist. “The way private practices are economically set up, they don’t have large reserves of capital or liquidity. We’re not like Apple or these big companies that have these massive cushions. It’s one thing when you have a downturn in the economy and less people come to get care, but when you have a complete shutdown, your revenue stream to pay your bills is literally dried up.”

Dr. Jain’s practice is part of Texas Digestive Disease Consultants (TDDC), which provides GI care for patients in Texas and Louisiana. TDDC is part of GI Alliance, a private equity–based consolidation of practices that includes several states and more than 350 GIs. The management services organization is a collaboration between the PE firm and the partner physicians. Since the COVID-19 outbreak, Dr. Jain said his practice has seen a dramatic drop in patients. Normally, Dr. Jain would perform between 25 and 30 outpatient scopes over the course of 2 days, he said. On a recent Monday, he performed two procedures. To preserve cash flow, Dr. Jain said he and his senior partners are not taking an income right now. Some employees were recently furloughed and laid off.

“I never in my life thought that I would have to lay off people because of an economic issue,” Dr. Jain said. “That’s psychological strain that as a physician owner you feel because these are people that you work with on a day-to-day basis and you don’t want them suffering either. That’s been a tough thing.

James S. Leavitt, MD, said his 17-physician center in Miami, Fla., has furloughed about half its staff. The center is part of Gastro Health, a private equity firm–based medical group with more than 250 providers in four states. Dr. Leavitt, president and chief clinical officer for Gastro Health, said his center has gone from about 150 patients per day to 5 or fewer, while procedures have dropped from more than 100 a day to maybe 5.

Having partnered with a private equity firm, however, Dr. Leavitt believes his practice is bettered situated to manage the health crisis and address financial challenges.

“It’s made us better prepared to weather the storm. We have a very high-powered, sophisticated administration and much broader base and access to capital. [For example,] we had a lot of depth in management so that we could roll out a robust televisit program in a week in four states with over 250 doctors.”

From a business standpoint, however, certain goals for the company are on hold, he said, such as closing on potential acquisitions.

Telemedicine works well for many patients, particularly for follow-up patients and for patients who have an established relationship with Dr. Leavitt, he said. There are limitations of course, he noted.

“If I were a dermatologist, maybe I could see the skin rash, but you can’t examine the patient,” he said. “There are certain things you can’t do. If a patient has significant abdominal pain, a televisit isn’t the greatest.”

That’s why Dr. Leavitt’s care center remains open for the handful of patients who must be seen in-person, he said. Those patients are screened beforehand and their temperatures taken before treatment.

Dr. Bulsiewicz’s practice made the transition to telehealth after never having used the modality before COVID-19.

“This was a scramble,” said Dr. Bulsiewicz, who posts about COVID-19 on social media. “We started from zero knowledge to implementation in less than a week.”

Overall, the switch went smoothly, but Dr. Bulsiewicz said reimbursement challenges come with telehealth.

“The billing is not the same,” he said. “You’re doing the same work or more, and you’re taking a reduced fee because of the antiquated fee structure that is forcing you to apply the typical rules of an office encounter.”

He hopes CMS will alter the reimbursement schedule to temporarily pay on par with traditional evaluation and management codes based on medical complexity as opposed to documentation of physical exam. CMS has already expanded Medicare telehealth coverage to cover a wider range of health care services in light of the COVID-19 crisis and also broadened the range of communication tools that can be used, according to a March announcement.

In the meantime, many practices have applied for financial assistance programs. The AGA recently pushed the government for additional assistance to help struggling practices.

Dr. Jain hopes these assistance programs roll out quickly.

“If these don’t get out there quick enough and big enough, we are going to see a massive wave of loss of independent practices and/or consolidation,” he said. “I fear a death to small, independent practices because they’re not going to have the financial wherewithal to tolerate this for too long.”
 

agallegos@mdedge.com

On a typical clinic day, Will Bulsiewicz, MD, a Charleston, S.C.–based gastroenterologist, used to see 22 patients, while other days were filled with up to 16 procedures.

Since COVID-19 however, things have vastly changed. Dr. Bulsiewicz now visits with all clinic patients through telehealth, and the volume has dipped to between zero and six patients per day. His three-doctor practice has also experienced a more than 90% reduction in endoscopy volume.

“Naturally, this has been devastating,” Dr. Bulsiewicz said in an interview. “Our practice was started in 1984, and we had a business model that we used for the history of our practice. That practice model was upended in a matter of 2 weeks.”

Dr. Bulsiewicz is far from alone. Community GI practices across the country are experiencing similar financial distress in the face of COVID-19. In addition to a decrease in patient referrals, the Centers for Medicare & Medicaid Services has requested that all elective esophagogastroduodenoscopies, colonoscopies, endoscopies, surgeries, and procedures be delayed during the coronavirus outbreak to conserve critical equipment and limit virus exposure. The guidance aligns with recent recommendations issued by American Gastroenterological Association, American Association for the Study of Liver Diseases, American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy. The lack of patients has led to plummeting revenue for many GI practices and resulted in layoffs, reduced hours, and limited salaries in order to keep practices afloat.

“We’ve had to make drastic changes in the way we work,” said Rajeev Jain, MD, AGAF, a Dallas-based gastroenterologist. “The way private practices are economically set up, they don’t have large reserves of capital or liquidity. We’re not like Apple or these big companies that have these massive cushions. It’s one thing when you have a downturn in the economy and less people come to get care, but when you have a complete shutdown, your revenue stream to pay your bills is literally dried up.”

Dr. Jain’s practice is part of Texas Digestive Disease Consultants (TDDC), which provides GI care for patients in Texas and Louisiana. TDDC is part of GI Alliance, a private equity–based consolidation of practices that includes several states and more than 350 GIs. The management services organization is a collaboration between the PE firm and the partner physicians. Since the COVID-19 outbreak, Dr. Jain said his practice has seen a dramatic drop in patients. Normally, Dr. Jain would perform between 25 and 30 outpatient scopes over the course of 2 days, he said. On a recent Monday, he performed two procedures. To preserve cash flow, Dr. Jain said he and his senior partners are not taking an income right now. Some employees were recently furloughed and laid off.

“I never in my life thought that I would have to lay off people because of an economic issue,” Dr. Jain said. “That’s psychological strain that as a physician owner you feel because these are people that you work with on a day-to-day basis and you don’t want them suffering either. That’s been a tough thing.

James S. Leavitt, MD, said his 17-physician center in Miami, Fla., has furloughed about half its staff. The center is part of Gastro Health, a private equity firm–based medical group with more than 250 providers in four states. Dr. Leavitt, president and chief clinical officer for Gastro Health, said his center has gone from about 150 patients per day to 5 or fewer, while procedures have dropped from more than 100 a day to maybe 5.

Having partnered with a private equity firm, however, Dr. Leavitt believes his practice is bettered situated to manage the health crisis and address financial challenges.

“It’s made us better prepared to weather the storm. We have a very high-powered, sophisticated administration and much broader base and access to capital. [For example,] we had a lot of depth in management so that we could roll out a robust televisit program in a week in four states with over 250 doctors.”

From a business standpoint, however, certain goals for the company are on hold, he said, such as closing on potential acquisitions.

Telemedicine works well for many patients, particularly for follow-up patients and for patients who have an established relationship with Dr. Leavitt, he said. There are limitations of course, he noted.

“If I were a dermatologist, maybe I could see the skin rash, but you can’t examine the patient,” he said. “There are certain things you can’t do. If a patient has significant abdominal pain, a televisit isn’t the greatest.”

That’s why Dr. Leavitt’s care center remains open for the handful of patients who must be seen in-person, he said. Those patients are screened beforehand and their temperatures taken before treatment.

Dr. Bulsiewicz’s practice made the transition to telehealth after never having used the modality before COVID-19.

“This was a scramble,” said Dr. Bulsiewicz, who posts about COVID-19 on social media. “We started from zero knowledge to implementation in less than a week.”

Overall, the switch went smoothly, but Dr. Bulsiewicz said reimbursement challenges come with telehealth.

“The billing is not the same,” he said. “You’re doing the same work or more, and you’re taking a reduced fee because of the antiquated fee structure that is forcing you to apply the typical rules of an office encounter.”

He hopes CMS will alter the reimbursement schedule to temporarily pay on par with traditional evaluation and management codes based on medical complexity as opposed to documentation of physical exam. CMS has already expanded Medicare telehealth coverage to cover a wider range of health care services in light of the COVID-19 crisis and also broadened the range of communication tools that can be used, according to a March announcement.

In the meantime, many practices have applied for financial assistance programs. The AGA recently pushed the government for additional assistance to help struggling practices.

Dr. Jain hopes these assistance programs roll out quickly.

“If these don’t get out there quick enough and big enough, we are going to see a massive wave of loss of independent practices and/or consolidation,” he said. “I fear a death to small, independent practices because they’re not going to have the financial wherewithal to tolerate this for too long.”
 

agallegos@mdedge.com

To manage patients with gynecologic cancers, oncologists in the United States and Europe are recommending reducing outpatient visits, delaying surgeries, prolonging chemotherapy regimens, and generally trying to keep cancer patients away from those who have tested positive for COVID-19.

“We recognize that, in this special situation, we must continue to provide our gynecologic oncology patients with the highest quality of medical services,” Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center in Houston and associates wrote in an editorial published in the International Journal of Gynecological Cancer.

At the same time, the authors added, the safety of patients, their families, and medical staff needs to be assured.

Dr. Ramirez and colleagues’ editorial includes recommendations on how to optimize the care of patients with gynecologic cancers while prioritizing safety and minimizing the burden to the healthcare system. The group’s recommendations outline when surgery, radiotherapy, and other treatments might be safely postponed and when they need to proceed out of urgency.

Some authors of the editorial also described their experiences with COVID-19 during a webinar on managing patients with advanced ovarian cancer, which was hosted by the European Society of Gynaecological Oncology (ESGO).
 

A lack of resources

In Spain, health resources “are collapsed” by the pandemic, editorial author Luis Chiva, MD, said during the webinar.

At his institution, the Clínica Universidad de Navarra in Madrid, 98% of the 1,500 intensive care beds were occupied by COVID-19 patients at the end of March. So the hope was to be able to refer their patients to other communities where there may still be some capacity.

Another problem in Spain is the high percentage of health workers infected with SARS-CoV-2, the virus behind COVID-19. More than 15,000 health workers were recently reported to be sick or self-isolating, which is around 14% of the health care workforce in the country.

Dr. Chiva noted that this puts those treating gynecologic cancers in a difficult position. On the one hand, surgery to remove a high-risk ovarian mass should not be delayed, but the majority of hospitals in Spain simply cannot perform this type of surgery during the pandemic.

“Unfortunately, due to this specific situation, almost, I would say in 80%-90% of hospitals, we are only able to carry out emergency surgical procedures,” Dr. Chiva said. That’s general emergency procedures such as appendectomies, removing blockages, and dealing with hemorrhages, not gynecologic surgeries. “It’s almost impossible to schedule the typical oncological cases,” he said.

Even with the Hospital IFEMA now set up at the Feria de Madrid, which is usually used to host large-scale events, there are “minimal options for performing standard oncological surgery,” Dr. Chiva said. He estimated that just 5% of hospitals in Spain are able to perform oncologic surgeries as normal, with maybe 15% able to offer surgery without the backup of postsurgical intensive care.
 

‘Ring-fencing’

“This is really an unusual time for us,” commented Jonathan Ledermann, MD, vice president of ESGO and a professor of medical oncology at University College London, who moderated the webinar.

“This is affecting the way in which we diagnose our patients and have access to care,” he said. “It compromises the way in which we treat patients. We have to adjust our treatment pathways. We have to look at the risks of coronavirus infection in cancer patients and how we manage patients in a socially distancing environment. We also need to think about managing gynecological oncology departments in the face of disease amongst staff, the risks of transmission, and the reduced clinical service.”

Dr. Ledermann noted that “ring-fencing” a few hospitals to deal only with patients free of COVID-19 might be a way forward. This approach has been used in Northern Italy and was recently started in London.

“We try to divide and have separate access between COVID-positive and -negative patients,” said Anna Fagotti, MD, an assistant professor at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome and another coauthor of the editorial.

“We are trying to divide the work flow of patients and try to ensure treatment to cancer patients as much as we can,” she explained. “This means that it’s a very difficult situation, and, every time, you have to deal with the number of places available as some places have been taken by other patients from the emergency room. We are still trying to have a number of beds and intensive care unit beds available for our patients.”

Setting up dedicated hospitals is a good idea, but it has to be done before the “tsunami” of cases hits and there are no more intensive care beds or ventilators, according to Antonio González-Martín, MD, of Clínica Universidad de Navarra in Madrid, another coauthor of the editorial.
 

Limiting hospital visits

Strategies to limit the number of times patients need to come into hospital for appointments and treatment is key to getting through the pandemic, Sandro Pignata, MD, of Instituto Nazionale Tumori IRCCS Fondazione G. Pascale in Naples, Italy, said during the webinar.

“It will be imperative to explore options that reduce the number of procedures or surgical interventions that may be associated with prolonged operative time, risk of major blood loss, necessitating blood products, risk of infection to the medical personnel, or admission to intensive care units,” Dr. Ramirez and colleagues wrote in their editorial.

“In considering management of disease, we must recognize that, in many centers, access to routine visits and surgery may be either completely restricted or significantly reduced. We must, therefore, consider options that may still offer our patients a treatment plan that addresses their disease while at the same time limiting risk of exposure,” the authors wrote.

The authors declared no competing interests or specific funding in relation to their work, and the webinar participants had no conflicts of interest.

SOURCE: Ramirez PT et al. Int J Gynecol Cancer. 2020 Mar 27. doi: 10.1136/ijgc-2020-001419.
 

To manage patients with gynecologic cancers, oncologists in the United States and Europe are recommending reducing outpatient visits, delaying surgeries, prolonging chemotherapy regimens, and generally trying to keep cancer patients away from those who have tested positive for COVID-19.

“We recognize that, in this special situation, we must continue to provide our gynecologic oncology patients with the highest quality of medical services,” Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center in Houston and associates wrote in an editorial published in the International Journal of Gynecological Cancer.

At the same time, the authors added, the safety of patients, their families, and medical staff needs to be assured.

Dr. Ramirez and colleagues’ editorial includes recommendations on how to optimize the care of patients with gynecologic cancers while prioritizing safety and minimizing the burden to the healthcare system. The group’s recommendations outline when surgery, radiotherapy, and other treatments might be safely postponed and when they need to proceed out of urgency.

Some authors of the editorial also described their experiences with COVID-19 during a webinar on managing patients with advanced ovarian cancer, which was hosted by the European Society of Gynaecological Oncology (ESGO).
 

A lack of resources

In Spain, health resources “are collapsed” by the pandemic, editorial author Luis Chiva, MD, said during the webinar.

At his institution, the Clínica Universidad de Navarra in Madrid, 98% of the 1,500 intensive care beds were occupied by COVID-19 patients at the end of March. So the hope was to be able to refer their patients to other communities where there may still be some capacity.

Another problem in Spain is the high percentage of health workers infected with SARS-CoV-2, the virus behind COVID-19. More than 15,000 health workers were recently reported to be sick or self-isolating, which is around 14% of the health care workforce in the country.

Dr. Chiva noted that this puts those treating gynecologic cancers in a difficult position. On the one hand, surgery to remove a high-risk ovarian mass should not be delayed, but the majority of hospitals in Spain simply cannot perform this type of surgery during the pandemic.

“Unfortunately, due to this specific situation, almost, I would say in 80%-90% of hospitals, we are only able to carry out emergency surgical procedures,” Dr. Chiva said. That’s general emergency procedures such as appendectomies, removing blockages, and dealing with hemorrhages, not gynecologic surgeries. “It’s almost impossible to schedule the typical oncological cases,” he said.

Even with the Hospital IFEMA now set up at the Feria de Madrid, which is usually used to host large-scale events, there are “minimal options for performing standard oncological surgery,” Dr. Chiva said. He estimated that just 5% of hospitals in Spain are able to perform oncologic surgeries as normal, with maybe 15% able to offer surgery without the backup of postsurgical intensive care.
 

‘Ring-fencing’

“This is really an unusual time for us,” commented Jonathan Ledermann, MD, vice president of ESGO and a professor of medical oncology at University College London, who moderated the webinar.

“This is affecting the way in which we diagnose our patients and have access to care,” he said. “It compromises the way in which we treat patients. We have to adjust our treatment pathways. We have to look at the risks of coronavirus infection in cancer patients and how we manage patients in a socially distancing environment. We also need to think about managing gynecological oncology departments in the face of disease amongst staff, the risks of transmission, and the reduced clinical service.”

Dr. Ledermann noted that “ring-fencing” a few hospitals to deal only with patients free of COVID-19 might be a way forward. This approach has been used in Northern Italy and was recently started in London.

“We try to divide and have separate access between COVID-positive and -negative patients,” said Anna Fagotti, MD, an assistant professor at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome and another coauthor of the editorial.

“We are trying to divide the work flow of patients and try to ensure treatment to cancer patients as much as we can,” she explained. “This means that it’s a very difficult situation, and, every time, you have to deal with the number of places available as some places have been taken by other patients from the emergency room. We are still trying to have a number of beds and intensive care unit beds available for our patients.”

Setting up dedicated hospitals is a good idea, but it has to be done before the “tsunami” of cases hits and there are no more intensive care beds or ventilators, according to Antonio González-Martín, MD, of Clínica Universidad de Navarra in Madrid, another coauthor of the editorial.
 

Limiting hospital visits

Strategies to limit the number of times patients need to come into hospital for appointments and treatment is key to getting through the pandemic, Sandro Pignata, MD, of Instituto Nazionale Tumori IRCCS Fondazione G. Pascale in Naples, Italy, said during the webinar.

“It will be imperative to explore options that reduce the number of procedures or surgical interventions that may be associated with prolonged operative time, risk of major blood loss, necessitating blood products, risk of infection to the medical personnel, or admission to intensive care units,” Dr. Ramirez and colleagues wrote in their editorial.

“In considering management of disease, we must recognize that, in many centers, access to routine visits and surgery may be either completely restricted or significantly reduced. We must, therefore, consider options that may still offer our patients a treatment plan that addresses their disease while at the same time limiting risk of exposure,” the authors wrote.

The authors declared no competing interests or specific funding in relation to their work, and the webinar participants had no conflicts of interest.

SOURCE: Ramirez PT et al. Int J Gynecol Cancer. 2020 Mar 27. doi: 10.1136/ijgc-2020-001419.
 

To manage patients with gynecologic cancers, oncologists in the United States and Europe are recommending reducing outpatient visits, delaying surgeries, prolonging chemotherapy regimens, and generally trying to keep cancer patients away from those who have tested positive for COVID-19.

“We recognize that, in this special situation, we must continue to provide our gynecologic oncology patients with the highest quality of medical services,” Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center in Houston and associates wrote in an editorial published in the International Journal of Gynecological Cancer.

At the same time, the authors added, the safety of patients, their families, and medical staff needs to be assured.

Dr. Ramirez and colleagues’ editorial includes recommendations on how to optimize the care of patients with gynecologic cancers while prioritizing safety and minimizing the burden to the healthcare system. The group’s recommendations outline when surgery, radiotherapy, and other treatments might be safely postponed and when they need to proceed out of urgency.

Some authors of the editorial also described their experiences with COVID-19 during a webinar on managing patients with advanced ovarian cancer, which was hosted by the European Society of Gynaecological Oncology (ESGO).
 

A lack of resources

In Spain, health resources “are collapsed” by the pandemic, editorial author Luis Chiva, MD, said during the webinar.

At his institution, the Clínica Universidad de Navarra in Madrid, 98% of the 1,500 intensive care beds were occupied by COVID-19 patients at the end of March. So the hope was to be able to refer their patients to other communities where there may still be some capacity.

Another problem in Spain is the high percentage of health workers infected with SARS-CoV-2, the virus behind COVID-19. More than 15,000 health workers were recently reported to be sick or self-isolating, which is around 14% of the health care workforce in the country.

Dr. Chiva noted that this puts those treating gynecologic cancers in a difficult position. On the one hand, surgery to remove a high-risk ovarian mass should not be delayed, but the majority of hospitals in Spain simply cannot perform this type of surgery during the pandemic.

“Unfortunately, due to this specific situation, almost, I would say in 80%-90% of hospitals, we are only able to carry out emergency surgical procedures,” Dr. Chiva said. That’s general emergency procedures such as appendectomies, removing blockages, and dealing with hemorrhages, not gynecologic surgeries. “It’s almost impossible to schedule the typical oncological cases,” he said.

Even with the Hospital IFEMA now set up at the Feria de Madrid, which is usually used to host large-scale events, there are “minimal options for performing standard oncological surgery,” Dr. Chiva said. He estimated that just 5% of hospitals in Spain are able to perform oncologic surgeries as normal, with maybe 15% able to offer surgery without the backup of postsurgical intensive care.
 

‘Ring-fencing’

“This is really an unusual time for us,” commented Jonathan Ledermann, MD, vice president of ESGO and a professor of medical oncology at University College London, who moderated the webinar.

“This is affecting the way in which we diagnose our patients and have access to care,” he said. “It compromises the way in which we treat patients. We have to adjust our treatment pathways. We have to look at the risks of coronavirus infection in cancer patients and how we manage patients in a socially distancing environment. We also need to think about managing gynecological oncology departments in the face of disease amongst staff, the risks of transmission, and the reduced clinical service.”

Dr. Ledermann noted that “ring-fencing” a few hospitals to deal only with patients free of COVID-19 might be a way forward. This approach has been used in Northern Italy and was recently started in London.

“We try to divide and have separate access between COVID-positive and -negative patients,” said Anna Fagotti, MD, an assistant professor at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome and another coauthor of the editorial.

“We are trying to divide the work flow of patients and try to ensure treatment to cancer patients as much as we can,” she explained. “This means that it’s a very difficult situation, and, every time, you have to deal with the number of places available as some places have been taken by other patients from the emergency room. We are still trying to have a number of beds and intensive care unit beds available for our patients.”

Setting up dedicated hospitals is a good idea, but it has to be done before the “tsunami” of cases hits and there are no more intensive care beds or ventilators, according to Antonio González-Martín, MD, of Clínica Universidad de Navarra in Madrid, another coauthor of the editorial.
 

Limiting hospital visits

Strategies to limit the number of times patients need to come into hospital for appointments and treatment is key to getting through the pandemic, Sandro Pignata, MD, of Instituto Nazionale Tumori IRCCS Fondazione G. Pascale in Naples, Italy, said during the webinar.

“It will be imperative to explore options that reduce the number of procedures or surgical interventions that may be associated with prolonged operative time, risk of major blood loss, necessitating blood products, risk of infection to the medical personnel, or admission to intensive care units,” Dr. Ramirez and colleagues wrote in their editorial.

“In considering management of disease, we must recognize that, in many centers, access to routine visits and surgery may be either completely restricted or significantly reduced. We must, therefore, consider options that may still offer our patients a treatment plan that addresses their disease while at the same time limiting risk of exposure,” the authors wrote.

The authors declared no competing interests or specific funding in relation to their work, and the webinar participants had no conflicts of interest.

SOURCE: Ramirez PT et al. Int J Gynecol Cancer. 2020 Mar 27. doi: 10.1136/ijgc-2020-001419.
 

The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” the CMS stated in a fact sheet highlighting the regulatory changes.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

For Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

In addition, CMS is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet. Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements and allowing greater use of verbal orders so that clinicians can spend more time on direct patient care.

Another change announced deals with the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program. Clinicians affected by the pandemic can request reweighting of the MIPS performance categories for the 2019 performance year, which will allow clinicians who are unable to submit MIPS data in the current submission period to request reweighting and receive a neutral payment adjustment in the 2021 payment year.

CMS also added an option for calendar year 2020 in the improvement activity category. Clinicians will receive credit if they are participating in a clinical trial that uses a drug or biological product to treat a COVID-19 patient and they report the findings to a clinical trial repository or registry.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including ED visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

CMS noted that providers can report telehealth for new and established patients, even if the billing code is specific for established patients only. CMS also has removed requirements regarding documentation of medical history and/or physical examination in the medical records during the COVID-19 crisis to help facilitate the use of telehealth for evaluation and management visits.

To help practices financially, providers who participate in Medicare fee-for-service will be able to request up to a 100% advance on their Medicare payments for a 3-month period. Repayment begins 120 days after the advance payment is received and must be paid within 210 days of the payment. Repayment will be automatically deducted from claims processed.

The agency also included new exceptions to the Stark Law. Some examples include the ability for hospitals to pay above or below fair market value to rent equipment or receive services from physicians and the allowance of health care providers to provide financial assistance to each other to ensure continuity of operations.

*This story was updated on 4/17/2020.

gtwachtman@mdedge.com

The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” the CMS stated in a fact sheet highlighting the regulatory changes.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

For Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

In addition, CMS is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet. Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements and allowing greater use of verbal orders so that clinicians can spend more time on direct patient care.

Another change announced deals with the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program. Clinicians affected by the pandemic can request reweighting of the MIPS performance categories for the 2019 performance year, which will allow clinicians who are unable to submit MIPS data in the current submission period to request reweighting and receive a neutral payment adjustment in the 2021 payment year.

CMS also added an option for calendar year 2020 in the improvement activity category. Clinicians will receive credit if they are participating in a clinical trial that uses a drug or biological product to treat a COVID-19 patient and they report the findings to a clinical trial repository or registry.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including ED visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

CMS noted that providers can report telehealth for new and established patients, even if the billing code is specific for established patients only. CMS also has removed requirements regarding documentation of medical history and/or physical examination in the medical records during the COVID-19 crisis to help facilitate the use of telehealth for evaluation and management visits.

To help practices financially, providers who participate in Medicare fee-for-service will be able to request up to a 100% advance on their Medicare payments for a 3-month period. Repayment begins 120 days after the advance payment is received and must be paid within 210 days of the payment. Repayment will be automatically deducted from claims processed.

The agency also included new exceptions to the Stark Law. Some examples include the ability for hospitals to pay above or below fair market value to rent equipment or receive services from physicians and the allowance of health care providers to provide financial assistance to each other to ensure continuity of operations.

*This story was updated on 4/17/2020.

gtwachtman@mdedge.com

The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” the CMS stated in a fact sheet highlighting the regulatory changes.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

For Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

In addition, CMS is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet. Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements and allowing greater use of verbal orders so that clinicians can spend more time on direct patient care.

Another change announced deals with the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program. Clinicians affected by the pandemic can request reweighting of the MIPS performance categories for the 2019 performance year, which will allow clinicians who are unable to submit MIPS data in the current submission period to request reweighting and receive a neutral payment adjustment in the 2021 payment year.

CMS also added an option for calendar year 2020 in the improvement activity category. Clinicians will receive credit if they are participating in a clinical trial that uses a drug or biological product to treat a COVID-19 patient and they report the findings to a clinical trial repository or registry.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including ED visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

CMS noted that providers can report telehealth for new and established patients, even if the billing code is specific for established patients only. CMS also has removed requirements regarding documentation of medical history and/or physical examination in the medical records during the COVID-19 crisis to help facilitate the use of telehealth for evaluation and management visits.

To help practices financially, providers who participate in Medicare fee-for-service will be able to request up to a 100% advance on their Medicare payments for a 3-month period. Repayment begins 120 days after the advance payment is received and must be paid within 210 days of the payment. Repayment will be automatically deducted from claims processed.

The agency also included new exceptions to the Stark Law. Some examples include the ability for hospitals to pay above or below fair market value to rent equipment or receive services from physicians and the allowance of health care providers to provide financial assistance to each other to ensure continuity of operations.

*This story was updated on 4/17/2020.

gtwachtman@mdedge.com

Pediatric patients with allergic rhinoconjunctivitis (AR/C) who received ragweed sublingual immunotherapy (SLIT) tablets had improvements in their comorbid asthma during ragweed pollen season, compared with placebo, according to recent research that was to be presented as an abstract for the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled its annual meeting and provided abstracts and access to presenters for press coverage.

Photo courtesy Oak Ridge National Laboratory

David I. Bernstein, MD, professor emeritus in the division of immunology, allergy and rheumatology at the University of Cincinnati and principal investigator at the Bernstein Clinical Research Center, examined exploratory endpoints of an international, double-blind, placebo-controlled trial evaluating ragweed SLIT tablets (Ragwitek; Merck) in 1,022 children with AR/C. The children enrolled were aged 5-17 years with ragweed AR/C, with 42.7% of the group having a history of asthma and the rest without asthma. Participants were included if they had a predicted first expiratory volume in 1 second (FEV₁) of ≥ 80% and if they required high-dose inhaled corticosteroids (ICS) to control their asthma or had severe, unstable, or uncontrolled asthma. The children were randomized to receive a 12 Amb a 1-unit dose of the ragweed SLIT tablet or placebo each day for 28 weeks.

The primary outcome was the total combined score (TCS), which was the sum of the daily symptom score and medication scores during ragweed season, but researchers also examined three exploratory endpoints. All patients were evaluated for their average asthma daily symptom score at the peak of ragweed pollen season and during the entire season, which was measured on a 0-3 scale based on symptoms of cough, wheeze, and chest tightness or shortness of breath. Within a subgroup of 406 participants with asthma, Dr. Bernstein and colleagues examined use of average daily short-acting beta agonists (SABA), and the number of times per week a participant would use a SABA at night at the peak of ragweed season as well as across the whole season.

Researchers found the TCS improved by 38% during ragweed pollen season in the group receiving ragweed SLIT tablets (least-square [LS] mean TCS, 7.12), compared with placebo (LS mean TCS, 4.39; P < .001). Among the asthma exploratory outcomes, asthma daily symptom scores improved by 30.7% during the peak of the season (–46.9% vs. –9.6%; LS mean difference, –0.13) and by 23.1% during the whole season (­–38.7% vs. –2.3%; LS mean difference, –0.09), compared with the placebo group. The mean number of daily puffs of rescue medication also decreased by 68.1% in the peak of ragweed season (–87.6% vs. –39.0%; LS mean difference, −0.14) and by 61.4% during the whole season (–80.9% vs. −32.9%; LS mean difference, –0.12) among participants taking ragweed SLIT tablets, compared with placebo. Participants in the group receiving ragweed SLIT tablets also had fewer nights awake using rescue medication, with a relative improvement of 75.1% during peak season (−99.3% vs. −35.2%; LS mean difference, −0.08) and 52.2% during the whole season (−80.4% vs. −3.7%; LS mean difference, −0.03), compared with the placebo group.

This magnitude of difference in the number of nocturnal awakenings in the treated group, compared with the placebo group, is similar to what researchers have seen in trials evaluating ICS or mometasone/formoterol, Dr. Bernstein said in an interview.

“Even though the magnitude in terms of difference in asthma symptoms and requirements for short-acting beta agonists was less than that of other studies of other drugs, it may reflect the fact these participants have less severe asthma,” said Dr. Bernstein. “But, there was an effect, and we did see some interesting differences between the placebo group and the treated group. This, I think, does generate at least a hypothesis that this could be an effective treatment for seasonal asthma, which would require future studies to determine that.”

Dr. Bernstein said that there were no adverse events from ragweed SLIT tablets unique to children with or without asthma, and although the data from this study cannot be compared directly to an adult population, there appeared to be a greater effect size for children than in trials evaluating adults. Compared with treatment options like subcutaneous immunotherapy, ragweed SLIT tablets may offer a relatively safer and more effective option for children and their parents, he said.

“The problem with kids is that they don’t particularly like the idea of getting injections. There’s a lot of needle-type injection phobia,” Dr. Bernstein said. “For a child who has maybe one or two major problem pollen seasons like during the ragweed and grass, they could do this.”

Ragwitek was approved by the Food and Drug Administration in 2014 for the treatment of adults with allergic rhinitis. Dr. Bernstein noted that Merck submitted this trial to the Food and Drug Administration as evidence of its effectiveness in children to secure a pediatric indication for the treatment.

This trial was funded by Merck, the developers of Ragwitek. The authors received medical writing and editing assistance from Scott Medical Communications, which was funded by ALK. Dr. Bernstein reports being on the advisory board for ALK America and GlaxoSmithKline; a consultant for Gerson-Lehman and Guidepoint Global; and received grant support from Aimmune, ALK, Amgen, AstraZeneca, Avillion, Biocryst, Boehringer Ingelheim, Cipla, Genentech, GlaxoSmithKline, Gossamer, Leo, Lupin, Menlo, Merck, Mylan, Novartis, Novum, Pearl, Regeneron, Shire, and TEVA. The other authors reported no relevant conflicts of interest.

SOURCE: Bernstein D et al. AAAAI 2020, Abstract 270.

Pediatric patients with allergic rhinoconjunctivitis (AR/C) who received ragweed sublingual immunotherapy (SLIT) tablets had improvements in their comorbid asthma during ragweed pollen season, compared with placebo, according to recent research that was to be presented as an abstract for the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled its annual meeting and provided abstracts and access to presenters for press coverage.

Photo courtesy Oak Ridge National Laboratory

David I. Bernstein, MD, professor emeritus in the division of immunology, allergy and rheumatology at the University of Cincinnati and principal investigator at the Bernstein Clinical Research Center, examined exploratory endpoints of an international, double-blind, placebo-controlled trial evaluating ragweed SLIT tablets (Ragwitek; Merck) in 1,022 children with AR/C. The children enrolled were aged 5-17 years with ragweed AR/C, with 42.7% of the group having a history of asthma and the rest without asthma. Participants were included if they had a predicted first expiratory volume in 1 second (FEV₁) of ≥ 80% and if they required high-dose inhaled corticosteroids (ICS) to control their asthma or had severe, unstable, or uncontrolled asthma. The children were randomized to receive a 12 Amb a 1-unit dose of the ragweed SLIT tablet or placebo each day for 28 weeks.

The primary outcome was the total combined score (TCS), which was the sum of the daily symptom score and medication scores during ragweed season, but researchers also examined three exploratory endpoints. All patients were evaluated for their average asthma daily symptom score at the peak of ragweed pollen season and during the entire season, which was measured on a 0-3 scale based on symptoms of cough, wheeze, and chest tightness or shortness of breath. Within a subgroup of 406 participants with asthma, Dr. Bernstein and colleagues examined use of average daily short-acting beta agonists (SABA), and the number of times per week a participant would use a SABA at night at the peak of ragweed season as well as across the whole season.

Researchers found the TCS improved by 38% during ragweed pollen season in the group receiving ragweed SLIT tablets (least-square [LS] mean TCS, 7.12), compared with placebo (LS mean TCS, 4.39; P < .001). Among the asthma exploratory outcomes, asthma daily symptom scores improved by 30.7% during the peak of the season (–46.9% vs. –9.6%; LS mean difference, –0.13) and by 23.1% during the whole season (­–38.7% vs. –2.3%; LS mean difference, –0.09), compared with the placebo group. The mean number of daily puffs of rescue medication also decreased by 68.1% in the peak of ragweed season (–87.6% vs. –39.0%; LS mean difference, −0.14) and by 61.4% during the whole season (–80.9% vs. −32.9%; LS mean difference, –0.12) among participants taking ragweed SLIT tablets, compared with placebo. Participants in the group receiving ragweed SLIT tablets also had fewer nights awake using rescue medication, with a relative improvement of 75.1% during peak season (−99.3% vs. −35.2%; LS mean difference, −0.08) and 52.2% during the whole season (−80.4% vs. −3.7%; LS mean difference, −0.03), compared with the placebo group.

This magnitude of difference in the number of nocturnal awakenings in the treated group, compared with the placebo group, is similar to what researchers have seen in trials evaluating ICS or mometasone/formoterol, Dr. Bernstein said in an interview.

“Even though the magnitude in terms of difference in asthma symptoms and requirements for short-acting beta agonists was less than that of other studies of other drugs, it may reflect the fact these participants have less severe asthma,” said Dr. Bernstein. “But, there was an effect, and we did see some interesting differences between the placebo group and the treated group. This, I think, does generate at least a hypothesis that this could be an effective treatment for seasonal asthma, which would require future studies to determine that.”

Dr. Bernstein said that there were no adverse events from ragweed SLIT tablets unique to children with or without asthma, and although the data from this study cannot be compared directly to an adult population, there appeared to be a greater effect size for children than in trials evaluating adults. Compared with treatment options like subcutaneous immunotherapy, ragweed SLIT tablets may offer a relatively safer and more effective option for children and their parents, he said.

“The problem with kids is that they don’t particularly like the idea of getting injections. There’s a lot of needle-type injection phobia,” Dr. Bernstein said. “For a child who has maybe one or two major problem pollen seasons like during the ragweed and grass, they could do this.”

Ragwitek was approved by the Food and Drug Administration in 2014 for the treatment of adults with allergic rhinitis. Dr. Bernstein noted that Merck submitted this trial to the Food and Drug Administration as evidence of its effectiveness in children to secure a pediatric indication for the treatment.

This trial was funded by Merck, the developers of Ragwitek. The authors received medical writing and editing assistance from Scott Medical Communications, which was funded by ALK. Dr. Bernstein reports being on the advisory board for ALK America and GlaxoSmithKline; a consultant for Gerson-Lehman and Guidepoint Global; and received grant support from Aimmune, ALK, Amgen, AstraZeneca, Avillion, Biocryst, Boehringer Ingelheim, Cipla, Genentech, GlaxoSmithKline, Gossamer, Leo, Lupin, Menlo, Merck, Mylan, Novartis, Novum, Pearl, Regeneron, Shire, and TEVA. The other authors reported no relevant conflicts of interest.

SOURCE: Bernstein D et al. AAAAI 2020, Abstract 270.

Pediatric patients with allergic rhinoconjunctivitis (AR/C) who received ragweed sublingual immunotherapy (SLIT) tablets had improvements in their comorbid asthma during ragweed pollen season, compared with placebo, according to recent research that was to be presented as an abstract for the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled its annual meeting and provided abstracts and access to presenters for press coverage.

Photo courtesy Oak Ridge National Laboratory

David I. Bernstein, MD, professor emeritus in the division of immunology, allergy and rheumatology at the University of Cincinnati and principal investigator at the Bernstein Clinical Research Center, examined exploratory endpoints of an international, double-blind, placebo-controlled trial evaluating ragweed SLIT tablets (Ragwitek; Merck) in 1,022 children with AR/C. The children enrolled were aged 5-17 years with ragweed AR/C, with 42.7% of the group having a history of asthma and the rest without asthma. Participants were included if they had a predicted first expiratory volume in 1 second (FEV₁) of ≥ 80% and if they required high-dose inhaled corticosteroids (ICS) to control their asthma or had severe, unstable, or uncontrolled asthma. The children were randomized to receive a 12 Amb a 1-unit dose of the ragweed SLIT tablet or placebo each day for 28 weeks.

The primary outcome was the total combined score (TCS), which was the sum of the daily symptom score and medication scores during ragweed season, but researchers also examined three exploratory endpoints. All patients were evaluated for their average asthma daily symptom score at the peak of ragweed pollen season and during the entire season, which was measured on a 0-3 scale based on symptoms of cough, wheeze, and chest tightness or shortness of breath. Within a subgroup of 406 participants with asthma, Dr. Bernstein and colleagues examined use of average daily short-acting beta agonists (SABA), and the number of times per week a participant would use a SABA at night at the peak of ragweed season as well as across the whole season.

Researchers found the TCS improved by 38% during ragweed pollen season in the group receiving ragweed SLIT tablets (least-square [LS] mean TCS, 7.12), compared with placebo (LS mean TCS, 4.39; P < .001). Among the asthma exploratory outcomes, asthma daily symptom scores improved by 30.7% during the peak of the season (–46.9% vs. –9.6%; LS mean difference, –0.13) and by 23.1% during the whole season (­–38.7% vs. –2.3%; LS mean difference, –0.09), compared with the placebo group. The mean number of daily puffs of rescue medication also decreased by 68.1% in the peak of ragweed season (–87.6% vs. –39.0%; LS mean difference, −0.14) and by 61.4% during the whole season (–80.9% vs. −32.9%; LS mean difference, –0.12) among participants taking ragweed SLIT tablets, compared with placebo. Participants in the group receiving ragweed SLIT tablets also had fewer nights awake using rescue medication, with a relative improvement of 75.1% during peak season (−99.3% vs. −35.2%; LS mean difference, −0.08) and 52.2% during the whole season (−80.4% vs. −3.7%; LS mean difference, −0.03), compared with the placebo group.

This magnitude of difference in the number of nocturnal awakenings in the treated group, compared with the placebo group, is similar to what researchers have seen in trials evaluating ICS or mometasone/formoterol, Dr. Bernstein said in an interview.

“Even though the magnitude in terms of difference in asthma symptoms and requirements for short-acting beta agonists was less than that of other studies of other drugs, it may reflect the fact these participants have less severe asthma,” said Dr. Bernstein. “But, there was an effect, and we did see some interesting differences between the placebo group and the treated group. This, I think, does generate at least a hypothesis that this could be an effective treatment for seasonal asthma, which would require future studies to determine that.”

Dr. Bernstein said that there were no adverse events from ragweed SLIT tablets unique to children with or without asthma, and although the data from this study cannot be compared directly to an adult population, there appeared to be a greater effect size for children than in trials evaluating adults. Compared with treatment options like subcutaneous immunotherapy, ragweed SLIT tablets may offer a relatively safer and more effective option for children and their parents, he said.

“The problem with kids is that they don’t particularly like the idea of getting injections. There’s a lot of needle-type injection phobia,” Dr. Bernstein said. “For a child who has maybe one or two major problem pollen seasons like during the ragweed and grass, they could do this.”

Ragwitek was approved by the Food and Drug Administration in 2014 for the treatment of adults with allergic rhinitis. Dr. Bernstein noted that Merck submitted this trial to the Food and Drug Administration as evidence of its effectiveness in children to secure a pediatric indication for the treatment.

This trial was funded by Merck, the developers of Ragwitek. The authors received medical writing and editing assistance from Scott Medical Communications, which was funded by ALK. Dr. Bernstein reports being on the advisory board for ALK America and GlaxoSmithKline; a consultant for Gerson-Lehman and Guidepoint Global; and received grant support from Aimmune, ALK, Amgen, AstraZeneca, Avillion, Biocryst, Boehringer Ingelheim, Cipla, Genentech, GlaxoSmithKline, Gossamer, Leo, Lupin, Menlo, Merck, Mylan, Novartis, Novum, Pearl, Regeneron, Shire, and TEVA. The other authors reported no relevant conflicts of interest.

SOURCE: Bernstein D et al. AAAAI 2020, Abstract 270.

Although a low blood sodium level has been shown to be a prognostic factor for a number of disorders, it has not been reported on for sickle cell disease, according to French researchers Jean-Simon Rech, MD, and colleagues.

Courtesy Wikimedia Commons/Osaro Erhabor/Creative Commons License

They found that hyponatremia at hospital admission was predictive of complications in initially uncomplicated episodes of painful episodes of sickle cell disease (SCD), according to their study published online in the American Journal of Medicine. Dr. Rech is with the department of internal medicine, Sickle Cell Disease Reference Center, Tenon Hospital, Assistance Publique-Hôpitaux de Paris.

The study assessed 1,218 stays (406 patients) admitted to a single center and the analyses were adjusted for age, sex, hemoglobin genotype and concentration, LDH concentration, and white blood cell count.

The researchers found that hyponatremia (defined as plasma sodium ≤ 135 mmol/L) was significantly associated with the primary endpoint of a composite criterion including acute chest syndrome, intensive care unit transfer, red blood cell transfusion, or inpatient death (P = .001).

With regard to the components of the primary endpoint, hyponatremia was significantly associated with acute chest syndrome (P = .008), as well as with receiving a red blood cell transfusion (P < .001) However, hyponatremia at admission was not significantly associated with intensive care unit transfer (P = .074) and there were no patient deaths.

In addition, hyponatremia was significantly associated with longer stays: 1.1 days adjusted mean length of stay (P < .001).

“Hyponatremia may lead to direct clinical consequences in the management of sickle cell disease patients. Indeed, a plasma sodium concentration ≤ 135mmol/L at admission or a decreasing natremia over the first days of an acute painful episode could be regarded as early signs of incipient acute chest syndrome, prompting clinicians to closely monitor the clinical status of their patients,” the researchers concluded.

The authors declared that they had no conflicts and that there was no funding source.

mlesney@mededge.com

SOURCE: Rech JS et al. Am J Med. 2020 Mar 18. doi.org/10.1016/j.amjmed.2020.02.017.

Although a low blood sodium level has been shown to be a prognostic factor for a number of disorders, it has not been reported on for sickle cell disease, according to French researchers Jean-Simon Rech, MD, and colleagues.

Courtesy Wikimedia Commons/Osaro Erhabor/Creative Commons License

They found that hyponatremia at hospital admission was predictive of complications in initially uncomplicated episodes of painful episodes of sickle cell disease (SCD), according to their study published online in the American Journal of Medicine. Dr. Rech is with the department of internal medicine, Sickle Cell Disease Reference Center, Tenon Hospital, Assistance Publique-Hôpitaux de Paris.

The study assessed 1,218 stays (406 patients) admitted to a single center and the analyses were adjusted for age, sex, hemoglobin genotype and concentration, LDH concentration, and white blood cell count.

The researchers found that hyponatremia (defined as plasma sodium ≤ 135 mmol/L) was significantly associated with the primary endpoint of a composite criterion including acute chest syndrome, intensive care unit transfer, red blood cell transfusion, or inpatient death (P = .001).

With regard to the components of the primary endpoint, hyponatremia was significantly associated with acute chest syndrome (P = .008), as well as with receiving a red blood cell transfusion (P < .001) However, hyponatremia at admission was not significantly associated with intensive care unit transfer (P = .074) and there were no patient deaths.

In addition, hyponatremia was significantly associated with longer stays: 1.1 days adjusted mean length of stay (P < .001).

“Hyponatremia may lead to direct clinical consequences in the management of sickle cell disease patients. Indeed, a plasma sodium concentration ≤ 135mmol/L at admission or a decreasing natremia over the first days of an acute painful episode could be regarded as early signs of incipient acute chest syndrome, prompting clinicians to closely monitor the clinical status of their patients,” the researchers concluded.

The authors declared that they had no conflicts and that there was no funding source.

mlesney@mededge.com

SOURCE: Rech JS et al. Am J Med. 2020 Mar 18. doi.org/10.1016/j.amjmed.2020.02.017.

Although a low blood sodium level has been shown to be a prognostic factor for a number of disorders, it has not been reported on for sickle cell disease, according to French researchers Jean-Simon Rech, MD, and colleagues.

Courtesy Wikimedia Commons/Osaro Erhabor/Creative Commons License

They found that hyponatremia at hospital admission was predictive of complications in initially uncomplicated episodes of painful episodes of sickle cell disease (SCD), according to their study published online in the American Journal of Medicine. Dr. Rech is with the department of internal medicine, Sickle Cell Disease Reference Center, Tenon Hospital, Assistance Publique-Hôpitaux de Paris.

The study assessed 1,218 stays (406 patients) admitted to a single center and the analyses were adjusted for age, sex, hemoglobin genotype and concentration, LDH concentration, and white blood cell count.

The researchers found that hyponatremia (defined as plasma sodium ≤ 135 mmol/L) was significantly associated with the primary endpoint of a composite criterion including acute chest syndrome, intensive care unit transfer, red blood cell transfusion, or inpatient death (P = .001).

With regard to the components of the primary endpoint, hyponatremia was significantly associated with acute chest syndrome (P = .008), as well as with receiving a red blood cell transfusion (P < .001) However, hyponatremia at admission was not significantly associated with intensive care unit transfer (P = .074) and there were no patient deaths.

In addition, hyponatremia was significantly associated with longer stays: 1.1 days adjusted mean length of stay (P < .001).

“Hyponatremia may lead to direct clinical consequences in the management of sickle cell disease patients. Indeed, a plasma sodium concentration ≤ 135mmol/L at admission or a decreasing natremia over the first days of an acute painful episode could be regarded as early signs of incipient acute chest syndrome, prompting clinicians to closely monitor the clinical status of their patients,” the researchers concluded.

The authors declared that they had no conflicts and that there was no funding source.

mlesney@mededge.com

SOURCE: Rech JS et al. Am J Med. 2020 Mar 18. doi.org/10.1016/j.amjmed.2020.02.017.

Parents of children with cancer and their physicians are willing to opt for less effective treatment to avoid risk of neurocognitive disorders later in life, according to results from a new study.

While some 80% of children with cancer survive to adulthood, most will experience chronic health conditions related to treatment, and many pediatric oncologists will adjust treatment strategies to lessen the likelihood of later effects. For their research published in Pediatrics, Katie A. Greenzang, MD, of the Dana-Farber Cancer Institute in Boston and colleagues aimed to learn how both parents and physicians weighed the risks and benefits.

In a survey of 95 parents and 41 physicians at Dana-Farber, Dr. Greenzang and colleagues proposed hypothetical scenarios involving five common late effects of childhood cancer treatment: neurocognitive impairment, infertility, cardiac toxicity, second malignancies, and impaired development. The parents surveyed, all of whom had children diagnosed with cancer within the previous year, were asked to make decisions as though on behalf of their children, while physicians were asked to do so as on behalf of a newly diagnosed patient.

Avoiding severe cognitive impairment mattered more than an increased chance of a cure to both parents and physicians. Neurocognitive impairment was the risk that most affected treatment choices, with parents more likely to choose a treatment associated with no or mild neurocognitive impairment, compared with one that caused severe impairment (odds ratio, 2.83 for no impairment vs. severe impairment; P less than .001), which was also the case with physicians (OR, 4.01; P less than .001).

Parents would accept an 18% chance of another malignancy for a 10% greater chance of a cure, while physicians accepted a 15% risk. Parents were willing to tolerate a 31% risk of cardiac toxicity in exchange for the better chance of a cure, while physicians accepted a 22% higher risk.

The results, the researchers wrote in their analysis, offered a window into the level and type of later-life risks that parents can accept when making choices about cancer treatment and where those choices appear to differ from those made by physicians.

“Oncologists increasingly design clinical trials [for children with cancer] with dual goals of optimizing cure while minimizing late effects,” Dr. Greenzang and colleagues wrote. “In doing so, they make judgments about the relative value of short- and long-term outcomes in patients’ lives. Yet oncologists have largely done so in the absence of information about how parents prioritize avoidance of late effects relative to the chance of cure.”

In an editorial comment accompanying the study, Tara A. Brinkman, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and James G. Gurney, PhD, of the University of Memphis noted that the findings “may have narrow clinical application” because many of the late-life effects presented in the survey will not present singly but will co-occur in survivors of childhood cancer. “Hypothetical scenarios that do not depict the full burden of late effects may not reflect a realistic understanding of the complexity of decisions to be made in a real-life diagnostic setting,” they said.

But the editorialists praised the study for revealing that many parents did not accurately perceive the true likelihood of late effects for their children. Parents in the survey tended to underestimate the risk for all the late effects besides infertility, which revealed a need for “better education about late effects early in the diagnostic and treatment process,” Dr. Brinkman and Dr. Gurney said, emphasizing that discussions should begin at diagnosis and continue beyond treatment “and long into the maintenance and surveillance period after the declaration of cure.”

Dr. Greenzang and colleagues’ study was funded by the National Institutes of Health and an Agency for Healthcare Research and Quality grant. The investigators declared no relevant financial disclosures. Dr. Brinkman and Dr. Gurney reported no relevant financial disclosures.

SOURCE: Greenzang et al. Pediatrics. 2020;145(5):e20193552.

Parents of children with cancer and their physicians are willing to opt for less effective treatment to avoid risk of neurocognitive disorders later in life, according to results from a new study.

While some 80% of children with cancer survive to adulthood, most will experience chronic health conditions related to treatment, and many pediatric oncologists will adjust treatment strategies to lessen the likelihood of later effects. For their research published in Pediatrics, Katie A. Greenzang, MD, of the Dana-Farber Cancer Institute in Boston and colleagues aimed to learn how both parents and physicians weighed the risks and benefits.

In a survey of 95 parents and 41 physicians at Dana-Farber, Dr. Greenzang and colleagues proposed hypothetical scenarios involving five common late effects of childhood cancer treatment: neurocognitive impairment, infertility, cardiac toxicity, second malignancies, and impaired development. The parents surveyed, all of whom had children diagnosed with cancer within the previous year, were asked to make decisions as though on behalf of their children, while physicians were asked to do so as on behalf of a newly diagnosed patient.

Avoiding severe cognitive impairment mattered more than an increased chance of a cure to both parents and physicians. Neurocognitive impairment was the risk that most affected treatment choices, with parents more likely to choose a treatment associated with no or mild neurocognitive impairment, compared with one that caused severe impairment (odds ratio, 2.83 for no impairment vs. severe impairment; P less than .001), which was also the case with physicians (OR, 4.01; P less than .001).

Parents would accept an 18% chance of another malignancy for a 10% greater chance of a cure, while physicians accepted a 15% risk. Parents were willing to tolerate a 31% risk of cardiac toxicity in exchange for the better chance of a cure, while physicians accepted a 22% higher risk.

The results, the researchers wrote in their analysis, offered a window into the level and type of later-life risks that parents can accept when making choices about cancer treatment and where those choices appear to differ from those made by physicians.

“Oncologists increasingly design clinical trials [for children with cancer] with dual goals of optimizing cure while minimizing late effects,” Dr. Greenzang and colleagues wrote. “In doing so, they make judgments about the relative value of short- and long-term outcomes in patients’ lives. Yet oncologists have largely done so in the absence of information about how parents prioritize avoidance of late effects relative to the chance of cure.”

In an editorial comment accompanying the study, Tara A. Brinkman, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and James G. Gurney, PhD, of the University of Memphis noted that the findings “may have narrow clinical application” because many of the late-life effects presented in the survey will not present singly but will co-occur in survivors of childhood cancer. “Hypothetical scenarios that do not depict the full burden of late effects may not reflect a realistic understanding of the complexity of decisions to be made in a real-life diagnostic setting,” they said.

But the editorialists praised the study for revealing that many parents did not accurately perceive the true likelihood of late effects for their children. Parents in the survey tended to underestimate the risk for all the late effects besides infertility, which revealed a need for “better education about late effects early in the diagnostic and treatment process,” Dr. Brinkman and Dr. Gurney said, emphasizing that discussions should begin at diagnosis and continue beyond treatment “and long into the maintenance and surveillance period after the declaration of cure.”

Dr. Greenzang and colleagues’ study was funded by the National Institutes of Health and an Agency for Healthcare Research and Quality grant. The investigators declared no relevant financial disclosures. Dr. Brinkman and Dr. Gurney reported no relevant financial disclosures.

SOURCE: Greenzang et al. Pediatrics. 2020;145(5):e20193552.

Parents of children with cancer and their physicians are willing to opt for less effective treatment to avoid risk of neurocognitive disorders later in life, according to results from a new study.

While some 80% of children with cancer survive to adulthood, most will experience chronic health conditions related to treatment, and many pediatric oncologists will adjust treatment strategies to lessen the likelihood of later effects. For their research published in Pediatrics, Katie A. Greenzang, MD, of the Dana-Farber Cancer Institute in Boston and colleagues aimed to learn how both parents and physicians weighed the risks and benefits.

In a survey of 95 parents and 41 physicians at Dana-Farber, Dr. Greenzang and colleagues proposed hypothetical scenarios involving five common late effects of childhood cancer treatment: neurocognitive impairment, infertility, cardiac toxicity, second malignancies, and impaired development. The parents surveyed, all of whom had children diagnosed with cancer within the previous year, were asked to make decisions as though on behalf of their children, while physicians were asked to do so as on behalf of a newly diagnosed patient.

Avoiding severe cognitive impairment mattered more than an increased chance of a cure to both parents and physicians. Neurocognitive impairment was the risk that most affected treatment choices, with parents more likely to choose a treatment associated with no or mild neurocognitive impairment, compared with one that caused severe impairment (odds ratio, 2.83 for no impairment vs. severe impairment; P less than .001), which was also the case with physicians (OR, 4.01; P less than .001).

Parents would accept an 18% chance of another malignancy for a 10% greater chance of a cure, while physicians accepted a 15% risk. Parents were willing to tolerate a 31% risk of cardiac toxicity in exchange for the better chance of a cure, while physicians accepted a 22% higher risk.

The results, the researchers wrote in their analysis, offered a window into the level and type of later-life risks that parents can accept when making choices about cancer treatment and where those choices appear to differ from those made by physicians.

“Oncologists increasingly design clinical trials [for children with cancer] with dual goals of optimizing cure while minimizing late effects,” Dr. Greenzang and colleagues wrote. “In doing so, they make judgments about the relative value of short- and long-term outcomes in patients’ lives. Yet oncologists have largely done so in the absence of information about how parents prioritize avoidance of late effects relative to the chance of cure.”

In an editorial comment accompanying the study, Tara A. Brinkman, PhD, of St. Jude Children’s Research Hospital in Memphis, Tenn., and James G. Gurney, PhD, of the University of Memphis noted that the findings “may have narrow clinical application” because many of the late-life effects presented in the survey will not present singly but will co-occur in survivors of childhood cancer. “Hypothetical scenarios that do not depict the full burden of late effects may not reflect a realistic understanding of the complexity of decisions to be made in a real-life diagnostic setting,” they said.

But the editorialists praised the study for revealing that many parents did not accurately perceive the true likelihood of late effects for their children. Parents in the survey tended to underestimate the risk for all the late effects besides infertility, which revealed a need for “better education about late effects early in the diagnostic and treatment process,” Dr. Brinkman and Dr. Gurney said, emphasizing that discussions should begin at diagnosis and continue beyond treatment “and long into the maintenance and surveillance period after the declaration of cure.”

Dr. Greenzang and colleagues’ study was funded by the National Institutes of Health and an Agency for Healthcare Research and Quality grant. The investigators declared no relevant financial disclosures. Dr. Brinkman and Dr. Gurney reported no relevant financial disclosures.

SOURCE: Greenzang et al. Pediatrics. 2020;145(5):e20193552.

Rates of minimally invasive surgery for early-stage endometrial cancer may be higher than previously reported, results of a registry study suggest.

Of 3,730 women with endometrial cancer in the Society of Gynecologic Oncology Clinical Outcomes Registry (SGO-COR), 88.8% underwent minimally invasive procedures, reported Amanda Nickles Fader, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“When you have surgery with a gyn-oncologist who is specially trained in this type of surgery, we see that women have a very high likelihood of having the appropriate surgery, the minimally invasive surgery, and we thought that this benchmark of an 80% rate of minimally invasive surgery in these patients is very feasible and should be recognized as the standard of care,” Dr. Nickles Fader said in an interview.

Coinvestigator Summer B. Dewdney, MD, of Rush University Medical Center, Chicago, who was instrumental in creating and running the SGO-COR registry, said these findings are encouraging.

“We’re happy to see that rate. It’s the rate that it should be because minimally invasive surgery is the standard of care for endometrial cancer,” Dr. Dewdney said. She added, however, that data supplied to the registry come from gynecologic oncologists who are highly motivated to participate and follow best practice guidelines, which could skew the results slightly toward more favorable outcomes.

Results of the registry-based study are detailed in an abstract that was slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Assessing adherence to guidelines

In 2015, the SGO Clinical Practice Committee and the American College of Obstetricians and Gynecologists issued a practice bulletin, which stated that “minimally invasive surgery should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”

Similarly, National Comprehensive Cancer Network guidelines for uterine cancer state that “minimally invasive surgery is the preferred approach when technically feasible” for treatment of endometrial cancer confined to the uterus.

Despite these recommendations, the overall rate of minimally invasive endometrial cancer surgery in the United States is reported be around to 60%, Dr. Nickles Fader and colleagues wrote.

With this in mind, the investigators set out to determine the rate of minimally invasive surgery in women with apparent stage I, II, or III endometrial cancer who underwent hysterectomy with or without staging from 2012 to 2017 at a center reporting to SGO-COR.

The team identified 3,730 women treated at 25 SGO-COR centers; 12 of which were university-affiliated centers and 13 of which were nonuniversity based. Most patients (83.2%) had stage I disease, 4.7% had stage II cancer, and 12.1% had stage III disease. The median patient age was 57 years. Most patients (88%) were white, and two-thirds (67.1%) were obese. In all, 80.4% of samples had endometrioid histology, and 77.7% were either grade 1 or 2.
 

Factors associated with minimally invasive surgery

The data showed that 88.8% of patients underwent a minimally invasive hysterectomy, composed of robotic-assisted procedures in 73.9% of cases, laparoscopy in 13.4%, and vaginal access in 1.6%.

The proportion of patients who underwent a minimally invasive procedure was significantly higher at nonuniversity centers, compared with academic centers (92.6% vs. 82.7%; P < .0001), but rates of minimally invasive procedures did not differ significantly across U.S. geographic regions.

Dr. Dewdney said that the higher proportion of open surgeries performed at university centers may be attributable to those centers treating patients with more advanced disease or rare aggressive cancers that may not be amenable to a minimally invasive approach.

In a multivariate analysis, factors associated with a failure to perform minimally invasive surgery were black race of the patient (adjusted odds ratio, 0.57), body mass index over 35 kg/m² (aOR, 1.40), stage II disease (aOR, 0.49), stage III disease (aOR, 0.36), carcinosarcoma/leiomyosarcoma (aOR, 0.58), and university hospital (aOR, 3.46).

Looking at perioperative complications, the investigators found that laparotomy was associated with more in-hospital complications than minimally invasive procedures, including more unscheduled ICU stays (P < .001) and prolonged hospital stays (P = .0002).

Dr. Dewdney said that investigators are planning further registry-based studies focusing on ovarian cancer, uterine cancer, and cervical cancer.

Dr. Nickles Fader and Dr. Dewdney reported having no relevant conflicts of interest.

SOURCE: Nickles Fader A et al. SGO 2020, Abstract 63.

Rates of minimally invasive surgery for early-stage endometrial cancer may be higher than previously reported, results of a registry study suggest.

Of 3,730 women with endometrial cancer in the Society of Gynecologic Oncology Clinical Outcomes Registry (SGO-COR), 88.8% underwent minimally invasive procedures, reported Amanda Nickles Fader, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“When you have surgery with a gyn-oncologist who is specially trained in this type of surgery, we see that women have a very high likelihood of having the appropriate surgery, the minimally invasive surgery, and we thought that this benchmark of an 80% rate of minimally invasive surgery in these patients is very feasible and should be recognized as the standard of care,” Dr. Nickles Fader said in an interview.

Coinvestigator Summer B. Dewdney, MD, of Rush University Medical Center, Chicago, who was instrumental in creating and running the SGO-COR registry, said these findings are encouraging.

“We’re happy to see that rate. It’s the rate that it should be because minimally invasive surgery is the standard of care for endometrial cancer,” Dr. Dewdney said. She added, however, that data supplied to the registry come from gynecologic oncologists who are highly motivated to participate and follow best practice guidelines, which could skew the results slightly toward more favorable outcomes.

Results of the registry-based study are detailed in an abstract that was slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Assessing adherence to guidelines

In 2015, the SGO Clinical Practice Committee and the American College of Obstetricians and Gynecologists issued a practice bulletin, which stated that “minimally invasive surgery should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”

Similarly, National Comprehensive Cancer Network guidelines for uterine cancer state that “minimally invasive surgery is the preferred approach when technically feasible” for treatment of endometrial cancer confined to the uterus.

Despite these recommendations, the overall rate of minimally invasive endometrial cancer surgery in the United States is reported be around to 60%, Dr. Nickles Fader and colleagues wrote.

With this in mind, the investigators set out to determine the rate of minimally invasive surgery in women with apparent stage I, II, or III endometrial cancer who underwent hysterectomy with or without staging from 2012 to 2017 at a center reporting to SGO-COR.

The team identified 3,730 women treated at 25 SGO-COR centers; 12 of which were university-affiliated centers and 13 of which were nonuniversity based. Most patients (83.2%) had stage I disease, 4.7% had stage II cancer, and 12.1% had stage III disease. The median patient age was 57 years. Most patients (88%) were white, and two-thirds (67.1%) were obese. In all, 80.4% of samples had endometrioid histology, and 77.7% were either grade 1 or 2.
 

Factors associated with minimally invasive surgery

The data showed that 88.8% of patients underwent a minimally invasive hysterectomy, composed of robotic-assisted procedures in 73.9% of cases, laparoscopy in 13.4%, and vaginal access in 1.6%.

The proportion of patients who underwent a minimally invasive procedure was significantly higher at nonuniversity centers, compared with academic centers (92.6% vs. 82.7%; P < .0001), but rates of minimally invasive procedures did not differ significantly across U.S. geographic regions.

Dr. Dewdney said that the higher proportion of open surgeries performed at university centers may be attributable to those centers treating patients with more advanced disease or rare aggressive cancers that may not be amenable to a minimally invasive approach.

In a multivariate analysis, factors associated with a failure to perform minimally invasive surgery were black race of the patient (adjusted odds ratio, 0.57), body mass index over 35 kg/m² (aOR, 1.40), stage II disease (aOR, 0.49), stage III disease (aOR, 0.36), carcinosarcoma/leiomyosarcoma (aOR, 0.58), and university hospital (aOR, 3.46).

Looking at perioperative complications, the investigators found that laparotomy was associated with more in-hospital complications than minimally invasive procedures, including more unscheduled ICU stays (P < .001) and prolonged hospital stays (P = .0002).

Dr. Dewdney said that investigators are planning further registry-based studies focusing on ovarian cancer, uterine cancer, and cervical cancer.

Dr. Nickles Fader and Dr. Dewdney reported having no relevant conflicts of interest.

SOURCE: Nickles Fader A et al. SGO 2020, Abstract 63.

Rates of minimally invasive surgery for early-stage endometrial cancer may be higher than previously reported, results of a registry study suggest.

Of 3,730 women with endometrial cancer in the Society of Gynecologic Oncology Clinical Outcomes Registry (SGO-COR), 88.8% underwent minimally invasive procedures, reported Amanda Nickles Fader, MD, of Johns Hopkins Hospital, Baltimore, and colleagues.

“When you have surgery with a gyn-oncologist who is specially trained in this type of surgery, we see that women have a very high likelihood of having the appropriate surgery, the minimally invasive surgery, and we thought that this benchmark of an 80% rate of minimally invasive surgery in these patients is very feasible and should be recognized as the standard of care,” Dr. Nickles Fader said in an interview.

Coinvestigator Summer B. Dewdney, MD, of Rush University Medical Center, Chicago, who was instrumental in creating and running the SGO-COR registry, said these findings are encouraging.

“We’re happy to see that rate. It’s the rate that it should be because minimally invasive surgery is the standard of care for endometrial cancer,” Dr. Dewdney said. She added, however, that data supplied to the registry come from gynecologic oncologists who are highly motivated to participate and follow best practice guidelines, which could skew the results slightly toward more favorable outcomes.

Results of the registry-based study are detailed in an abstract that was slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Assessing adherence to guidelines

In 2015, the SGO Clinical Practice Committee and the American College of Obstetricians and Gynecologists issued a practice bulletin, which stated that “minimally invasive surgery should be embraced as the standard surgical approach for comprehensive surgical staging in women with endometrial cancer.”

Similarly, National Comprehensive Cancer Network guidelines for uterine cancer state that “minimally invasive surgery is the preferred approach when technically feasible” for treatment of endometrial cancer confined to the uterus.

Despite these recommendations, the overall rate of minimally invasive endometrial cancer surgery in the United States is reported be around to 60%, Dr. Nickles Fader and colleagues wrote.

With this in mind, the investigators set out to determine the rate of minimally invasive surgery in women with apparent stage I, II, or III endometrial cancer who underwent hysterectomy with or without staging from 2012 to 2017 at a center reporting to SGO-COR.

The team identified 3,730 women treated at 25 SGO-COR centers; 12 of which were university-affiliated centers and 13 of which were nonuniversity based. Most patients (83.2%) had stage I disease, 4.7% had stage II cancer, and 12.1% had stage III disease. The median patient age was 57 years. Most patients (88%) were white, and two-thirds (67.1%) were obese. In all, 80.4% of samples had endometrioid histology, and 77.7% were either grade 1 or 2.
 

Factors associated with minimally invasive surgery

The data showed that 88.8% of patients underwent a minimally invasive hysterectomy, composed of robotic-assisted procedures in 73.9% of cases, laparoscopy in 13.4%, and vaginal access in 1.6%.

The proportion of patients who underwent a minimally invasive procedure was significantly higher at nonuniversity centers, compared with academic centers (92.6% vs. 82.7%; P < .0001), but rates of minimally invasive procedures did not differ significantly across U.S. geographic regions.

Dr. Dewdney said that the higher proportion of open surgeries performed at university centers may be attributable to those centers treating patients with more advanced disease or rare aggressive cancers that may not be amenable to a minimally invasive approach.

In a multivariate analysis, factors associated with a failure to perform minimally invasive surgery were black race of the patient (adjusted odds ratio, 0.57), body mass index over 35 kg/m² (aOR, 1.40), stage II disease (aOR, 0.49), stage III disease (aOR, 0.36), carcinosarcoma/leiomyosarcoma (aOR, 0.58), and university hospital (aOR, 3.46).

Looking at perioperative complications, the investigators found that laparotomy was associated with more in-hospital complications than minimally invasive procedures, including more unscheduled ICU stays (P < .001) and prolonged hospital stays (P = .0002).

Dr. Dewdney said that investigators are planning further registry-based studies focusing on ovarian cancer, uterine cancer, and cervical cancer.

Dr. Nickles Fader and Dr. Dewdney reported having no relevant conflicts of interest.

SOURCE: Nickles Fader A et al. SGO 2020, Abstract 63.

Among patients admitted to a hospital with chronic obstructive pulmonary disease (COPD) exacerbation, obstructive sleep apnea (OSA) is prevalent and increases the likelihood of hospital readmission more than threefold, according to results from a single-center study published in CHEST.

Mario Naranjo, MD, and colleagues retrospectively examined data from Albert Einstein Medical Center in Philadelphia to assess the impact of OSA on hospital readmission within 30 days of discharge after treatment for a COPD exacerbation. Dr. Naranjo is affiliated with Johns Hopkins Medicine, Baltimore.

The researchers analyzed data from 238 patients admitted for COPD exacerbation between May 2017 and July 2018 who were screened for previously unrecognized and untreated OSA and underwent a high-resolution pulse-oximetry or portable sleep monitoring study. In all, 111 (46.6%) had OSA; 28.6% had mild OSA, 9.7% had moderate OSA, and 8.4% had severe OSA.

Most baseline characteristics were similar among patients with and without OSA, but patients with OSA had a greater mean body mass index (33.9 vs. 30.3 kg/m²) and were more likely to have comorbid heart failure (19.8% vs. 7.1%), compared with patients without OSA. In addition, the proportion of male patients was greater in the cohort with OSA (60.4% vs. 49.6%).

For patients with mild OSA (oxygen desaturation index [ODI] ≥ 5 and < 15/hour), the odds of 30-day readmission were 2.05 times higher, compared with patients without OSA (32.4% vs. 18.9%). With moderate OSA (ODI ≥ 15 and < 30/hour), the odds of 30-day readmission were 6.68 times higher (60.9% vs. 18.9%). For severe OSA (ODI ≥ 30/hour), the odds were 10.01 times higher (70.0% vs. 18.9%). “For combined OSA severity categories, the odds of 30-day readmission were 3.5 times higher,” said Dr. Naranjo and colleagues. In addition, 90- and 180-day readmission rates and 6-month mortality rates were higher among patients with OSA.

“These findings have important implications for the evaluation and care of patients admitted to the hospital for COPD exacerbations,” Dr. Naranjo and colleagues said. “Although the combination of COPD and OSA (also known as the “overlap syndrome”) in ambulatory settings has been shown to have worse outcomes in terms of COPD exacerbations and mortality, these findings have not been reported previously for hospitalized COPD patients.”

Greater degrees of nocturnal hypoxemia and hypercapnia, worse functional status, and daytime sleepiness and fatigue may contribute to the relationship between OSA and the likelihood of hospital readmission, according to the authors. A multicenter study is warranted to confirm the results, they said.

Dr. Naranjo had no conflicts of interest. Coauthors have received grants from ResMed, Dayzz, and the National Institutes of Health and consulted for Jazz Pharmaceuticals, Best Doctors, and ResMed. One author is a committee chair for the American Academy of Sleep Medicine.

jremaly@mdedge.com

SOURCE: Naranjo M et al. Chest. 2020 Apr 2. doi: 10.1016/j.chest.2020.03.036.

Among patients admitted to a hospital with chronic obstructive pulmonary disease (COPD) exacerbation, obstructive sleep apnea (OSA) is prevalent and increases the likelihood of hospital readmission more than threefold, according to results from a single-center study published in CHEST.

Mario Naranjo, MD, and colleagues retrospectively examined data from Albert Einstein Medical Center in Philadelphia to assess the impact of OSA on hospital readmission within 30 days of discharge after treatment for a COPD exacerbation. Dr. Naranjo is affiliated with Johns Hopkins Medicine, Baltimore.

The researchers analyzed data from 238 patients admitted for COPD exacerbation between May 2017 and July 2018 who were screened for previously unrecognized and untreated OSA and underwent a high-resolution pulse-oximetry or portable sleep monitoring study. In all, 111 (46.6%) had OSA; 28.6% had mild OSA, 9.7% had moderate OSA, and 8.4% had severe OSA.

Most baseline characteristics were similar among patients with and without OSA, but patients with OSA had a greater mean body mass index (33.9 vs. 30.3 kg/m²) and were more likely to have comorbid heart failure (19.8% vs. 7.1%), compared with patients without OSA. In addition, the proportion of male patients was greater in the cohort with OSA (60.4% vs. 49.6%).

For patients with mild OSA (oxygen desaturation index [ODI] ≥ 5 and < 15/hour), the odds of 30-day readmission were 2.05 times higher, compared with patients without OSA (32.4% vs. 18.9%). With moderate OSA (ODI ≥ 15 and < 30/hour), the odds of 30-day readmission were 6.68 times higher (60.9% vs. 18.9%). For severe OSA (ODI ≥ 30/hour), the odds were 10.01 times higher (70.0% vs. 18.9%). “For combined OSA severity categories, the odds of 30-day readmission were 3.5 times higher,” said Dr. Naranjo and colleagues. In addition, 90- and 180-day readmission rates and 6-month mortality rates were higher among patients with OSA.

“These findings have important implications for the evaluation and care of patients admitted to the hospital for COPD exacerbations,” Dr. Naranjo and colleagues said. “Although the combination of COPD and OSA (also known as the “overlap syndrome”) in ambulatory settings has been shown to have worse outcomes in terms of COPD exacerbations and mortality, these findings have not been reported previously for hospitalized COPD patients.”

Greater degrees of nocturnal hypoxemia and hypercapnia, worse functional status, and daytime sleepiness and fatigue may contribute to the relationship between OSA and the likelihood of hospital readmission, according to the authors. A multicenter study is warranted to confirm the results, they said.

Dr. Naranjo had no conflicts of interest. Coauthors have received grants from ResMed, Dayzz, and the National Institutes of Health and consulted for Jazz Pharmaceuticals, Best Doctors, and ResMed. One author is a committee chair for the American Academy of Sleep Medicine.

jremaly@mdedge.com

SOURCE: Naranjo M et al. Chest. 2020 Apr 2. doi: 10.1016/j.chest.2020.03.036.

Among patients admitted to a hospital with chronic obstructive pulmonary disease (COPD) exacerbation, obstructive sleep apnea (OSA) is prevalent and increases the likelihood of hospital readmission more than threefold, according to results from a single-center study published in CHEST.

Mario Naranjo, MD, and colleagues retrospectively examined data from Albert Einstein Medical Center in Philadelphia to assess the impact of OSA on hospital readmission within 30 days of discharge after treatment for a COPD exacerbation. Dr. Naranjo is affiliated with Johns Hopkins Medicine, Baltimore.

The researchers analyzed data from 238 patients admitted for COPD exacerbation between May 2017 and July 2018 who were screened for previously unrecognized and untreated OSA and underwent a high-resolution pulse-oximetry or portable sleep monitoring study. In all, 111 (46.6%) had OSA; 28.6% had mild OSA, 9.7% had moderate OSA, and 8.4% had severe OSA.

Most baseline characteristics were similar among patients with and without OSA, but patients with OSA had a greater mean body mass index (33.9 vs. 30.3 kg/m²) and were more likely to have comorbid heart failure (19.8% vs. 7.1%), compared with patients without OSA. In addition, the proportion of male patients was greater in the cohort with OSA (60.4% vs. 49.6%).

For patients with mild OSA (oxygen desaturation index [ODI] ≥ 5 and < 15/hour), the odds of 30-day readmission were 2.05 times higher, compared with patients without OSA (32.4% vs. 18.9%). With moderate OSA (ODI ≥ 15 and < 30/hour), the odds of 30-day readmission were 6.68 times higher (60.9% vs. 18.9%). For severe OSA (ODI ≥ 30/hour), the odds were 10.01 times higher (70.0% vs. 18.9%). “For combined OSA severity categories, the odds of 30-day readmission were 3.5 times higher,” said Dr. Naranjo and colleagues. In addition, 90- and 180-day readmission rates and 6-month mortality rates were higher among patients with OSA.

“These findings have important implications for the evaluation and care of patients admitted to the hospital for COPD exacerbations,” Dr. Naranjo and colleagues said. “Although the combination of COPD and OSA (also known as the “overlap syndrome”) in ambulatory settings has been shown to have worse outcomes in terms of COPD exacerbations and mortality, these findings have not been reported previously for hospitalized COPD patients.”

Greater degrees of nocturnal hypoxemia and hypercapnia, worse functional status, and daytime sleepiness and fatigue may contribute to the relationship between OSA and the likelihood of hospital readmission, according to the authors. A multicenter study is warranted to confirm the results, they said.

Dr. Naranjo had no conflicts of interest. Coauthors have received grants from ResMed, Dayzz, and the National Institutes of Health and consulted for Jazz Pharmaceuticals, Best Doctors, and ResMed. One author is a committee chair for the American Academy of Sleep Medicine.

jremaly@mdedge.com

SOURCE: Naranjo M et al. Chest. 2020 Apr 2. doi: 10.1016/j.chest.2020.03.036.