The rise in prevalence of the community spread of coronavirus disease 2019 (COVID-19) in the US in early March 2020 led to hospital systems across the country preparing for an increase in critically ill patients.¹ The US Department of Veterans Affairs (VA) Ann Arbor Healthcare System (VAAAHS) anticipated an increased census of veterans who would need hospital admission for severe COVID-19 as well as the potential need to receive patients from community hospitals in Southeast Michigan, the location of one of the worst outbreaks in the US at that time.²

Through the facility’s incident command center, a hospital operations group identified the postanesthesia care unit (PACU) as a space to convert to an intensive care unit (ICU) for patients with COVID-19 needing mechanical ventilation. Other hospitals throughout the world have created similar makeshift ICUs to help care for the surge of patients with COVID-19, recognizing the high level of monitoring and resources available in the perioperative setting.^3-5 These ICUs have been successfully created in operating rooms,³ recovery rooms,⁵ and procedural settings.⁴

Between March 27, 2020 and April 25, 2020, a great multidisciplinary effort enabled the VAAAHS PACU-ICU to care for critically ill veterans with COVID-19 from Southeast Michigan as well as civilian transfers from overwhelmed neighboring community hospitals. This article will discuss planning considerations, including facility preparation, equipment, and staffing models. The unique challenges faced in managing an open-plan surge-capacity ICU also will be discussed as well as the solutions that were enacted.

Methods

Hospital Preparation

Maintaining a 2-zone model in which patients with COVID-19 and without COVID-19 could be cared for separately was of major importance. The VAAAHS traditional ICU was converted into a 16-bed COVID-19 ICU and staffed by the Pulmonary Critical Care Service. A separate wing of the hospital was converted into a 19-bed non-COVID-19 ICU, which also was staffed by the Pulmonary Critical Care Service that increased its staffing of residents, fellows, and attending physicians to meet the increasing clinical demands. Elective major surgery cases were postponed, and surgeons managed the care of postoperative surgical ICU patients. This arrangement allowed the existing 4 anesthesiologist intensivists to staff the PACU COVID-19 ICU.

Considerations, including space requirements, staffing, equipment, infection control requirements, and ability for facilities to engineer a negative pressure space were factored into the decision to convert the PACU to an additional 12-bed ICU. This effectively tripled the VAAAHS ICU capacity, enabling patient transfers from the John D. Dingell VA Medical Center in Detroit, Michigan, which was being impacted by a surge of cases in Detroit. In addition, this allowed for the opening of the hospital for both COVID-19 and non-COVID-19 ICU transfers from hospitals in Southeast Michigan in order to fulfill the fourth VA mission to provide care and support to state and local communities for emergency management, public health, and safety.

PACU Preparation

PACU was selected as an overflow ICU due to its open floor plan, allowing patients on ventilators to be seen from a central nursing station. This would allow for the safe use of ventilators without central alarm capabilities (especially anesthesia machines). Given the risk of a circuit disconnect, all ventilators without central alarm capabilities needed to be seen and heard within the space to ensure patient safety.

Facilities Management was able to construct temporary barriers with vinyl covered sheetrock and plexiglass to partition the central nursing workstation from the patient area in a U-shape (Figure 1). The patient area was turned into a negative pressure space where strict airborne precautions could be observed. Although the air handling unit serving this space is equipped with high efficiency particulate air (HEPA) filters, it was mechanically manipulated to ensure that all air coming from the space was discharged through exhaust and not recirculated into another occupied space within the hospital. Total air exchange rates were measured and calculated for both the positive and negative spaces to ensure they met or exceeded at least 6 air changes per hour, as recommended by Occupational Safety and Health Administration guidance.^6,7 A differential pressure indicator was installed to provide staff with the ability to monitor the pressure relationship between the 2 spaces in real time.

Twelve patient care beds were created. A traditionally engineered airborne infection isolation room in PACU served as a procedure room for aerosol-generating procedures, especially intubation, extubation, use of high-flow nasal cannula, and tracheostomy placement. Strict airborne precautions were taken within the patient area. The area inside the nursing station was positively pressurized to allow for surgical masks only to be required for the comfort of health care workers (Figure 2). A clear donning and doffing workflow was created for movement between the nursing area and the patient care area.

Personal Protective Equipment

Personal protective equipment (PPE) was of paramount importance in this open care unit. Airborne precautions were used in the entire patient care area. Powered air-purifying respirators (PAPRs) were used when possible to conserve the supply of N95 masks. Each health care worker was issued a reusable PAPR hood, which was cleaned by the user after each use by wiping the exterior of the entire hood with virucidal wipes. The brand and active ingredient of the virucidal wipes varied by availability of supplies, but the “virus kill time” was clearly labeled on each container. Each health care worker had a paper bag for storing his or her PAPR hood between usage to allow drying and ventilation. PAPR units were charged in between uses and shared by all clinical staff. Two layers of nonsterile gloves were worn.

Because of the open care area, attention had to be given to adhere to infection control policies if health care workers wanted to care for multiple patients while in the area. A new gown was placed over the existing gown, and the outer layer of gloves was removed. The under layer of gloves was then sanitized with hand sanitizer, and a new pair of outer gloves was then worn.

Equipment

Much of the ICU-level equipment needed was already present within the operating room (OR) area. Existing patient monitors were used and connected to a central monitoring station present in the nurses station. Relevant contents of the ICU storage room were duplicated and placed on shelves in the patient care area. Out-of-use anesthesia carts were used for a dedicated COVID-19 invasive line cart. A designated ultrasound with cardiac and vascular access probes was assigned to the PACU-ICU. Anesthesia machines were brought into the PACU-ICU and prepared with viral filters in line to prevent contamination of the machines, in keeping with national guidance from the American Society of Anesthesiologists and Anesthesia Patient Safety Foundation.⁸

Multidisciplinary Staffing Model

With the reduced surgical and procedural case load due to halting nonemergent operations, the Anesthesiology and Perioperative Care Service was able to staff the PACU-ICU with critical care anesthesiologists, nurse anesthetists, residents, and PACU and procedural nurses without hindering access to emergent surgeries. A separate preoperative area was maintained with an 8-bed capacity for both preoperative and postoperative management of non-COVID-19 surgical patients.

The staffing model was designed using guidance on the expansion of ICU staffing with non-ICU resources from the Society of Critical Care Medicine as well as local guidance on appropriate nursing ratios (Figure 3).⁹ Given the high acuity and dynamic nature of COVID-19 coupled with the unique considerations that exist using anesthesia machines as long-term ICU ventilators, 24-hour inhospital attending intensivist coverage was provided in the ICU by 4 critical care anesthesiologists who rotated between 12-hour day and night shifts. The critical care anesthesiologists led a team of anesthesiology and surgery residents and ICU advanced practice providers dedicated solely to the PACU-ICU. Non-ICU anesthesiologists helped with procedures such as intubation and invasive line placement and provided coverage of the ICU patients during sign-out and rounding. Certified registered nurse anesthetists (CRNAs) performed intubations and helped offload respiratory therapists (one of the resources most in shortage) by managing and weaning ventilators and were instrumental in prone positioning of patients. Dedicated ICU nurses were deployed every shift to oversee the unit and act as a resource to the PACU nurses. Fortunately, many PACU nurses had prior ICU training and experience, and nurses from outpatient areas also were recruited to help with patient care. Together, they provided direct patient care. OR nurses assisted with delivering supplies, medications and transporting specimens to the laboratory, as no formal hospital tube station was present in the PACU.

Because of the open-unit setting, nurses practiced bundled care and staggered their turns in the patient care area. For example, a nurse who entered to administer medication to patient A, could then receive communication to check the urine output for patient B and do so without completely doffing and redonning. This allowed preservation of PPE and reduced time in PPE for the health care providers (HCPs).

A scheduled daily meeting included staff from PACU-ICU; Medical ICU (MICU), which also treated patients with COVID-19; and the Palliative Care Service (Figure 4). Patients with single-organ failure were preferentially sent to PACU-ICU, as the ability to do renal replacement therapy (RRT) in an open unit proved difficult. The palliative care team and VAAAHS social workers assisted both MICU and PACU-ICU with communicating with patients’ families, which provided a great help during a clinically demanding time. Physical therapists increased their staffing of the ICU to specifically help with mobilization of patients with COVID-19 and acute respiratory distress syndrome, given the prolonged mechanical ventilation courses that were seen. Other consulting services frequently involved included infectious disease and nephrology.

Challenges and Solutions

Communication between staff located within the patient area and staff located in the nursing station was difficult given the loud noise generated by a PAPR and the plexiglass walls that separated the areas. Multiple techniques were attempted to overcome this. Dry erase boards were placed within the space to facilitate requests, but these were found to be time consuming. Two-way radios worked well if the users were wearing N95s but were harder to communicate when users were wearing PAPRs. Baby monitors were purchased to facilitate 2-way communication and were useful at times although quieter than desired. Vocera B3000N Communication Badges, which were already utilized in the perioperative period at the facility, could be utilized underneath PPE and were ultimately the best form of clear communication between staff within the patient care area and outside the negative pressure zone. In accordance with company guidance, these mobile devices were cleaned with virucidal wipes after use.¹⁰

Communication with patients’ families was critically important. The ICU team, palliative care team, or social workers made daily telephone calls to family members. The facility telehealth coordinator provided a designated tablet device to enable the intensivists to video conference with the patients’ families at bedside, utilizing virtual care manager appointments. This allowed families to see and interact with their loved ones despite the prohibition of family visitors. Every effort was made to utilize video calling daily; however, clinical demands as well as Internet and technological constraints from individual family members intermittently precluded video calls.

Clinical Challenges

Patients with severe COVID-19 infections requiring mechanical ventilation have proven to be exceptionally high-acuity patients with myriad organ-based complications reported.¹¹ Specific to our PACU-ICU, we determined that it was impractical to arrange for continuous RRT given the amount of training PACU nursing staff would have required and the limited ICU nursing staff in the PACU-ICU. Intermittent hemodialysis required replumbing for water supply and drainage but was ultimately not required as our facility expanded the number of continuous RRT machines available, allowing all patients in the COVID-19 ICU who required RRT to stay in the 16-bed ICU. Daily communication with the MICU allowed for safe transfer of patients with imminent needs for RRT to the MICU, providing a coordinated strategy for the deployment of scarce resources across our expanded ICU footprint.

Using anesthesia machines as ICU ventilators proved challenging, despite following best practice guidance.⁸ Notably, anesthesia machines are not actively humidified and require very high fresh gas flows, necessitating the addition of heat moisture exchangers (HME) to the circuit. Also, viral filters were placed in the circuit to prevent machine contamination. The addition of the HME and viral filters to each circuit increased the present dead space and led todifficulty in providing adequate ventilation to patients who already may have had a high proportion of physiologic dead space. The high fresh gas flows used still seemed inadequate in preventing moisture buildup in the machine parts, necessitating frequent exchanges of viral filters, HMEs, and circuits to prevent high peak airway pressures. In addition, anesthesia machines directly sample gas from the patient's breathing circuit, creating the risk for contamination of the space. This required a reconfiguration to allow for a suction scavenging system by VAAAHS biomedical engineers. Also, anesthesia machines are not designed for long-term ventilation and have different ventilation modes compared with modern ICU ventilators. Although they were used for several patients when the PACU-ICU opened, the hospital was able to acquire additional ICU ventilators, and extensive or prolonged use of anesthesia machine ventilators was avoided.

Infection Control

The open care setting provided unique infection control issues that had to be addressed.¹² The open setting allowed preservation of PPE and the ability for bundled care to be delivered easily. The VAAAHS infection control team worked closely with the ICU team to develop practices to ensure both patient and health care worker protection. Notable challenges included donning new gowns between patients when a PAPR was already being worn, leading to draping of new gowns over existing gowns when going between patients. True hand hygiene was also difficult, as health care workers did not want to completely remove gloves while in the patient care area. Layering of 2 pairs of gloves allowed the outer gloves to be removed after care of each patient, at which time alcohol gel was applied to the inner gloves, a new gown was placed over the existing gown, and a new pair of gloves was layered on top.

Although patients were intubated for long periods in the PACU-ICU, there was concern for increased risk of exposure of health care workers after extubation given the inability to contain the coughing patients within a private room. If a patient did well, they were transferred to a private room on the general medical floors within 24 hours of extubation to minimize this risk.

Privacy

The open care design meant less privacy for patients than would be provided in a private room. Curtains were drawn around patient beds as much as possible, especially for nursing care, but priority was given to visualization of the ventilator when a HCP was not present to ensure safety at all times. The majority of patients cared for in the PACU-ICU were intubated and sedated on arrival, but thankfully many were extubated. After extubation privacy in the open care area became more of an issue and may have led to more nighttime disturbances and substandard delirium prevention measures. Priority was given to expediting the transfer of these patients to private rooms on the general medical floor once their respiratory status was deemed stable.

Conclusions

The COVID-19 pandemic is truly an unprecedented event in our nation’s history, which has led to the first nationwide authorization of the fourth mission of VA to provide support for national, state, and local public health. The PACU-ICU was designed, engineered, built, and staffed by perioperative HCPs through an exceptional multidisciplinary effort in a matter of days. Through this dedication of health care workers and staff, the VAAAHS was able to care for critically ill veterans from Southeast Michigan and serve the community during a time of overwhelming demand on the national health care system.

Acknowledgments

The authors thank the outstanding team of administrators, engineers, physical therapists, pharmacists, nurses, advanced practice providers, CRNAs, respiratory therapists, and physicians who made it possible to respond to our veterans’ and our community’s needs in a time of unprecedented demand on our health care system. A special thank you to Eric Deters, Chief Strategy Officer; Brittany McClure, ICU Nurse Manager; and Mark Dotson, Chief Supply Chain Officer. It was a privilege to serve on this mission together.

The rise in prevalence of the community spread of coronavirus disease 2019 (COVID-19) in the US in early March 2020 led to hospital systems across the country preparing for an increase in critically ill patients.¹ The US Department of Veterans Affairs (VA) Ann Arbor Healthcare System (VAAAHS) anticipated an increased census of veterans who would need hospital admission for severe COVID-19 as well as the potential need to receive patients from community hospitals in Southeast Michigan, the location of one of the worst outbreaks in the US at that time.²

Through the facility’s incident command center, a hospital operations group identified the postanesthesia care unit (PACU) as a space to convert to an intensive care unit (ICU) for patients with COVID-19 needing mechanical ventilation. Other hospitals throughout the world have created similar makeshift ICUs to help care for the surge of patients with COVID-19, recognizing the high level of monitoring and resources available in the perioperative setting.^3-5 These ICUs have been successfully created in operating rooms,³ recovery rooms,⁵ and procedural settings.⁴

Between March 27, 2020 and April 25, 2020, a great multidisciplinary effort enabled the VAAAHS PACU-ICU to care for critically ill veterans with COVID-19 from Southeast Michigan as well as civilian transfers from overwhelmed neighboring community hospitals. This article will discuss planning considerations, including facility preparation, equipment, and staffing models. The unique challenges faced in managing an open-plan surge-capacity ICU also will be discussed as well as the solutions that were enacted.

Methods

Hospital Preparation

Maintaining a 2-zone model in which patients with COVID-19 and without COVID-19 could be cared for separately was of major importance. The VAAAHS traditional ICU was converted into a 16-bed COVID-19 ICU and staffed by the Pulmonary Critical Care Service. A separate wing of the hospital was converted into a 19-bed non-COVID-19 ICU, which also was staffed by the Pulmonary Critical Care Service that increased its staffing of residents, fellows, and attending physicians to meet the increasing clinical demands. Elective major surgery cases were postponed, and surgeons managed the care of postoperative surgical ICU patients. This arrangement allowed the existing 4 anesthesiologist intensivists to staff the PACU COVID-19 ICU.

Considerations, including space requirements, staffing, equipment, infection control requirements, and ability for facilities to engineer a negative pressure space were factored into the decision to convert the PACU to an additional 12-bed ICU. This effectively tripled the VAAAHS ICU capacity, enabling patient transfers from the John D. Dingell VA Medical Center in Detroit, Michigan, which was being impacted by a surge of cases in Detroit. In addition, this allowed for the opening of the hospital for both COVID-19 and non-COVID-19 ICU transfers from hospitals in Southeast Michigan in order to fulfill the fourth VA mission to provide care and support to state and local communities for emergency management, public health, and safety.

PACU Preparation

PACU was selected as an overflow ICU due to its open floor plan, allowing patients on ventilators to be seen from a central nursing station. This would allow for the safe use of ventilators without central alarm capabilities (especially anesthesia machines). Given the risk of a circuit disconnect, all ventilators without central alarm capabilities needed to be seen and heard within the space to ensure patient safety.

Facilities Management was able to construct temporary barriers with vinyl covered sheetrock and plexiglass to partition the central nursing workstation from the patient area in a U-shape (Figure 1). The patient area was turned into a negative pressure space where strict airborne precautions could be observed. Although the air handling unit serving this space is equipped with high efficiency particulate air (HEPA) filters, it was mechanically manipulated to ensure that all air coming from the space was discharged through exhaust and not recirculated into another occupied space within the hospital. Total air exchange rates were measured and calculated for both the positive and negative spaces to ensure they met or exceeded at least 6 air changes per hour, as recommended by Occupational Safety and Health Administration guidance.^6,7 A differential pressure indicator was installed to provide staff with the ability to monitor the pressure relationship between the 2 spaces in real time.

Twelve patient care beds were created. A traditionally engineered airborne infection isolation room in PACU served as a procedure room for aerosol-generating procedures, especially intubation, extubation, use of high-flow nasal cannula, and tracheostomy placement. Strict airborne precautions were taken within the patient area. The area inside the nursing station was positively pressurized to allow for surgical masks only to be required for the comfort of health care workers (Figure 2). A clear donning and doffing workflow was created for movement between the nursing area and the patient care area.

Personal Protective Equipment

Personal protective equipment (PPE) was of paramount importance in this open care unit. Airborne precautions were used in the entire patient care area. Powered air-purifying respirators (PAPRs) were used when possible to conserve the supply of N95 masks. Each health care worker was issued a reusable PAPR hood, which was cleaned by the user after each use by wiping the exterior of the entire hood with virucidal wipes. The brand and active ingredient of the virucidal wipes varied by availability of supplies, but the “virus kill time” was clearly labeled on each container. Each health care worker had a paper bag for storing his or her PAPR hood between usage to allow drying and ventilation. PAPR units were charged in between uses and shared by all clinical staff. Two layers of nonsterile gloves were worn.

Because of the open care area, attention had to be given to adhere to infection control policies if health care workers wanted to care for multiple patients while in the area. A new gown was placed over the existing gown, and the outer layer of gloves was removed. The under layer of gloves was then sanitized with hand sanitizer, and a new pair of outer gloves was then worn.

Equipment

Much of the ICU-level equipment needed was already present within the operating room (OR) area. Existing patient monitors were used and connected to a central monitoring station present in the nurses station. Relevant contents of the ICU storage room were duplicated and placed on shelves in the patient care area. Out-of-use anesthesia carts were used for a dedicated COVID-19 invasive line cart. A designated ultrasound with cardiac and vascular access probes was assigned to the PACU-ICU. Anesthesia machines were brought into the PACU-ICU and prepared with viral filters in line to prevent contamination of the machines, in keeping with national guidance from the American Society of Anesthesiologists and Anesthesia Patient Safety Foundation.⁸

Multidisciplinary Staffing Model

With the reduced surgical and procedural case load due to halting nonemergent operations, the Anesthesiology and Perioperative Care Service was able to staff the PACU-ICU with critical care anesthesiologists, nurse anesthetists, residents, and PACU and procedural nurses without hindering access to emergent surgeries. A separate preoperative area was maintained with an 8-bed capacity for both preoperative and postoperative management of non-COVID-19 surgical patients.

The staffing model was designed using guidance on the expansion of ICU staffing with non-ICU resources from the Society of Critical Care Medicine as well as local guidance on appropriate nursing ratios (Figure 3).⁹ Given the high acuity and dynamic nature of COVID-19 coupled with the unique considerations that exist using anesthesia machines as long-term ICU ventilators, 24-hour inhospital attending intensivist coverage was provided in the ICU by 4 critical care anesthesiologists who rotated between 12-hour day and night shifts. The critical care anesthesiologists led a team of anesthesiology and surgery residents and ICU advanced practice providers dedicated solely to the PACU-ICU. Non-ICU anesthesiologists helped with procedures such as intubation and invasive line placement and provided coverage of the ICU patients during sign-out and rounding. Certified registered nurse anesthetists (CRNAs) performed intubations and helped offload respiratory therapists (one of the resources most in shortage) by managing and weaning ventilators and were instrumental in prone positioning of patients. Dedicated ICU nurses were deployed every shift to oversee the unit and act as a resource to the PACU nurses. Fortunately, many PACU nurses had prior ICU training and experience, and nurses from outpatient areas also were recruited to help with patient care. Together, they provided direct patient care. OR nurses assisted with delivering supplies, medications and transporting specimens to the laboratory, as no formal hospital tube station was present in the PACU.

Because of the open-unit setting, nurses practiced bundled care and staggered their turns in the patient care area. For example, a nurse who entered to administer medication to patient A, could then receive communication to check the urine output for patient B and do so without completely doffing and redonning. This allowed preservation of PPE and reduced time in PPE for the health care providers (HCPs).

A scheduled daily meeting included staff from PACU-ICU; Medical ICU (MICU), which also treated patients with COVID-19; and the Palliative Care Service (Figure 4). Patients with single-organ failure were preferentially sent to PACU-ICU, as the ability to do renal replacement therapy (RRT) in an open unit proved difficult. The palliative care team and VAAAHS social workers assisted both MICU and PACU-ICU with communicating with patients’ families, which provided a great help during a clinically demanding time. Physical therapists increased their staffing of the ICU to specifically help with mobilization of patients with COVID-19 and acute respiratory distress syndrome, given the prolonged mechanical ventilation courses that were seen. Other consulting services frequently involved included infectious disease and nephrology.

Challenges and Solutions

Communication between staff located within the patient area and staff located in the nursing station was difficult given the loud noise generated by a PAPR and the plexiglass walls that separated the areas. Multiple techniques were attempted to overcome this. Dry erase boards were placed within the space to facilitate requests, but these were found to be time consuming. Two-way radios worked well if the users were wearing N95s but were harder to communicate when users were wearing PAPRs. Baby monitors were purchased to facilitate 2-way communication and were useful at times although quieter than desired. Vocera B3000N Communication Badges, which were already utilized in the perioperative period at the facility, could be utilized underneath PPE and were ultimately the best form of clear communication between staff within the patient care area and outside the negative pressure zone. In accordance with company guidance, these mobile devices were cleaned with virucidal wipes after use.¹⁰

Communication with patients’ families was critically important. The ICU team, palliative care team, or social workers made daily telephone calls to family members. The facility telehealth coordinator provided a designated tablet device to enable the intensivists to video conference with the patients’ families at bedside, utilizing virtual care manager appointments. This allowed families to see and interact with their loved ones despite the prohibition of family visitors. Every effort was made to utilize video calling daily; however, clinical demands as well as Internet and technological constraints from individual family members intermittently precluded video calls.

Clinical Challenges

Patients with severe COVID-19 infections requiring mechanical ventilation have proven to be exceptionally high-acuity patients with myriad organ-based complications reported.¹¹ Specific to our PACU-ICU, we determined that it was impractical to arrange for continuous RRT given the amount of training PACU nursing staff would have required and the limited ICU nursing staff in the PACU-ICU. Intermittent hemodialysis required replumbing for water supply and drainage but was ultimately not required as our facility expanded the number of continuous RRT machines available, allowing all patients in the COVID-19 ICU who required RRT to stay in the 16-bed ICU. Daily communication with the MICU allowed for safe transfer of patients with imminent needs for RRT to the MICU, providing a coordinated strategy for the deployment of scarce resources across our expanded ICU footprint.

Using anesthesia machines as ICU ventilators proved challenging, despite following best practice guidance.⁸ Notably, anesthesia machines are not actively humidified and require very high fresh gas flows, necessitating the addition of heat moisture exchangers (HME) to the circuit. Also, viral filters were placed in the circuit to prevent machine contamination. The addition of the HME and viral filters to each circuit increased the present dead space and led todifficulty in providing adequate ventilation to patients who already may have had a high proportion of physiologic dead space. The high fresh gas flows used still seemed inadequate in preventing moisture buildup in the machine parts, necessitating frequent exchanges of viral filters, HMEs, and circuits to prevent high peak airway pressures. In addition, anesthesia machines directly sample gas from the patient's breathing circuit, creating the risk for contamination of the space. This required a reconfiguration to allow for a suction scavenging system by VAAAHS biomedical engineers. Also, anesthesia machines are not designed for long-term ventilation and have different ventilation modes compared with modern ICU ventilators. Although they were used for several patients when the PACU-ICU opened, the hospital was able to acquire additional ICU ventilators, and extensive or prolonged use of anesthesia machine ventilators was avoided.

Infection Control

The open care setting provided unique infection control issues that had to be addressed.¹² The open setting allowed preservation of PPE and the ability for bundled care to be delivered easily. The VAAAHS infection control team worked closely with the ICU team to develop practices to ensure both patient and health care worker protection. Notable challenges included donning new gowns between patients when a PAPR was already being worn, leading to draping of new gowns over existing gowns when going between patients. True hand hygiene was also difficult, as health care workers did not want to completely remove gloves while in the patient care area. Layering of 2 pairs of gloves allowed the outer gloves to be removed after care of each patient, at which time alcohol gel was applied to the inner gloves, a new gown was placed over the existing gown, and a new pair of gloves was layered on top.

Although patients were intubated for long periods in the PACU-ICU, there was concern for increased risk of exposure of health care workers after extubation given the inability to contain the coughing patients within a private room. If a patient did well, they were transferred to a private room on the general medical floors within 24 hours of extubation to minimize this risk.

Privacy

The open care design meant less privacy for patients than would be provided in a private room. Curtains were drawn around patient beds as much as possible, especially for nursing care, but priority was given to visualization of the ventilator when a HCP was not present to ensure safety at all times. The majority of patients cared for in the PACU-ICU were intubated and sedated on arrival, but thankfully many were extubated. After extubation privacy in the open care area became more of an issue and may have led to more nighttime disturbances and substandard delirium prevention measures. Priority was given to expediting the transfer of these patients to private rooms on the general medical floor once their respiratory status was deemed stable.

Conclusions

The COVID-19 pandemic is truly an unprecedented event in our nation’s history, which has led to the first nationwide authorization of the fourth mission of VA to provide support for national, state, and local public health. The PACU-ICU was designed, engineered, built, and staffed by perioperative HCPs through an exceptional multidisciplinary effort in a matter of days. Through this dedication of health care workers and staff, the VAAAHS was able to care for critically ill veterans from Southeast Michigan and serve the community during a time of overwhelming demand on the national health care system.

Acknowledgments

The authors thank the outstanding team of administrators, engineers, physical therapists, pharmacists, nurses, advanced practice providers, CRNAs, respiratory therapists, and physicians who made it possible to respond to our veterans’ and our community’s needs in a time of unprecedented demand on our health care system. A special thank you to Eric Deters, Chief Strategy Officer; Brittany McClure, ICU Nurse Manager; and Mark Dotson, Chief Supply Chain Officer. It was a privilege to serve on this mission together.

The rise in prevalence of the community spread of coronavirus disease 2019 (COVID-19) in the US in early March 2020 led to hospital systems across the country preparing for an increase in critically ill patients.¹ The US Department of Veterans Affairs (VA) Ann Arbor Healthcare System (VAAAHS) anticipated an increased census of veterans who would need hospital admission for severe COVID-19 as well as the potential need to receive patients from community hospitals in Southeast Michigan, the location of one of the worst outbreaks in the US at that time.²

Through the facility’s incident command center, a hospital operations group identified the postanesthesia care unit (PACU) as a space to convert to an intensive care unit (ICU) for patients with COVID-19 needing mechanical ventilation. Other hospitals throughout the world have created similar makeshift ICUs to help care for the surge of patients with COVID-19, recognizing the high level of monitoring and resources available in the perioperative setting.^3-5 These ICUs have been successfully created in operating rooms,³ recovery rooms,⁵ and procedural settings.⁴

Between March 27, 2020 and April 25, 2020, a great multidisciplinary effort enabled the VAAAHS PACU-ICU to care for critically ill veterans with COVID-19 from Southeast Michigan as well as civilian transfers from overwhelmed neighboring community hospitals. This article will discuss planning considerations, including facility preparation, equipment, and staffing models. The unique challenges faced in managing an open-plan surge-capacity ICU also will be discussed as well as the solutions that were enacted.

Methods

Hospital Preparation

Maintaining a 2-zone model in which patients with COVID-19 and without COVID-19 could be cared for separately was of major importance. The VAAAHS traditional ICU was converted into a 16-bed COVID-19 ICU and staffed by the Pulmonary Critical Care Service. A separate wing of the hospital was converted into a 19-bed non-COVID-19 ICU, which also was staffed by the Pulmonary Critical Care Service that increased its staffing of residents, fellows, and attending physicians to meet the increasing clinical demands. Elective major surgery cases were postponed, and surgeons managed the care of postoperative surgical ICU patients. This arrangement allowed the existing 4 anesthesiologist intensivists to staff the PACU COVID-19 ICU.

Considerations, including space requirements, staffing, equipment, infection control requirements, and ability for facilities to engineer a negative pressure space were factored into the decision to convert the PACU to an additional 12-bed ICU. This effectively tripled the VAAAHS ICU capacity, enabling patient transfers from the John D. Dingell VA Medical Center in Detroit, Michigan, which was being impacted by a surge of cases in Detroit. In addition, this allowed for the opening of the hospital for both COVID-19 and non-COVID-19 ICU transfers from hospitals in Southeast Michigan in order to fulfill the fourth VA mission to provide care and support to state and local communities for emergency management, public health, and safety.

PACU Preparation

PACU was selected as an overflow ICU due to its open floor plan, allowing patients on ventilators to be seen from a central nursing station. This would allow for the safe use of ventilators without central alarm capabilities (especially anesthesia machines). Given the risk of a circuit disconnect, all ventilators without central alarm capabilities needed to be seen and heard within the space to ensure patient safety.

Facilities Management was able to construct temporary barriers with vinyl covered sheetrock and plexiglass to partition the central nursing workstation from the patient area in a U-shape (Figure 1). The patient area was turned into a negative pressure space where strict airborne precautions could be observed. Although the air handling unit serving this space is equipped with high efficiency particulate air (HEPA) filters, it was mechanically manipulated to ensure that all air coming from the space was discharged through exhaust and not recirculated into another occupied space within the hospital. Total air exchange rates were measured and calculated for both the positive and negative spaces to ensure they met or exceeded at least 6 air changes per hour, as recommended by Occupational Safety and Health Administration guidance.^6,7 A differential pressure indicator was installed to provide staff with the ability to monitor the pressure relationship between the 2 spaces in real time.

Twelve patient care beds were created. A traditionally engineered airborne infection isolation room in PACU served as a procedure room for aerosol-generating procedures, especially intubation, extubation, use of high-flow nasal cannula, and tracheostomy placement. Strict airborne precautions were taken within the patient area. The area inside the nursing station was positively pressurized to allow for surgical masks only to be required for the comfort of health care workers (Figure 2). A clear donning and doffing workflow was created for movement between the nursing area and the patient care area.

Personal Protective Equipment

Personal protective equipment (PPE) was of paramount importance in this open care unit. Airborne precautions were used in the entire patient care area. Powered air-purifying respirators (PAPRs) were used when possible to conserve the supply of N95 masks. Each health care worker was issued a reusable PAPR hood, which was cleaned by the user after each use by wiping the exterior of the entire hood with virucidal wipes. The brand and active ingredient of the virucidal wipes varied by availability of supplies, but the “virus kill time” was clearly labeled on each container. Each health care worker had a paper bag for storing his or her PAPR hood between usage to allow drying and ventilation. PAPR units were charged in between uses and shared by all clinical staff. Two layers of nonsterile gloves were worn.

Because of the open care area, attention had to be given to adhere to infection control policies if health care workers wanted to care for multiple patients while in the area. A new gown was placed over the existing gown, and the outer layer of gloves was removed. The under layer of gloves was then sanitized with hand sanitizer, and a new pair of outer gloves was then worn.

Equipment

Much of the ICU-level equipment needed was already present within the operating room (OR) area. Existing patient monitors were used and connected to a central monitoring station present in the nurses station. Relevant contents of the ICU storage room were duplicated and placed on shelves in the patient care area. Out-of-use anesthesia carts were used for a dedicated COVID-19 invasive line cart. A designated ultrasound with cardiac and vascular access probes was assigned to the PACU-ICU. Anesthesia machines were brought into the PACU-ICU and prepared with viral filters in line to prevent contamination of the machines, in keeping with national guidance from the American Society of Anesthesiologists and Anesthesia Patient Safety Foundation.⁸

Multidisciplinary Staffing Model

With the reduced surgical and procedural case load due to halting nonemergent operations, the Anesthesiology and Perioperative Care Service was able to staff the PACU-ICU with critical care anesthesiologists, nurse anesthetists, residents, and PACU and procedural nurses without hindering access to emergent surgeries. A separate preoperative area was maintained with an 8-bed capacity for both preoperative and postoperative management of non-COVID-19 surgical patients.

The staffing model was designed using guidance on the expansion of ICU staffing with non-ICU resources from the Society of Critical Care Medicine as well as local guidance on appropriate nursing ratios (Figure 3).⁹ Given the high acuity and dynamic nature of COVID-19 coupled with the unique considerations that exist using anesthesia machines as long-term ICU ventilators, 24-hour inhospital attending intensivist coverage was provided in the ICU by 4 critical care anesthesiologists who rotated between 12-hour day and night shifts. The critical care anesthesiologists led a team of anesthesiology and surgery residents and ICU advanced practice providers dedicated solely to the PACU-ICU. Non-ICU anesthesiologists helped with procedures such as intubation and invasive line placement and provided coverage of the ICU patients during sign-out and rounding. Certified registered nurse anesthetists (CRNAs) performed intubations and helped offload respiratory therapists (one of the resources most in shortage) by managing and weaning ventilators and were instrumental in prone positioning of patients. Dedicated ICU nurses were deployed every shift to oversee the unit and act as a resource to the PACU nurses. Fortunately, many PACU nurses had prior ICU training and experience, and nurses from outpatient areas also were recruited to help with patient care. Together, they provided direct patient care. OR nurses assisted with delivering supplies, medications and transporting specimens to the laboratory, as no formal hospital tube station was present in the PACU.

Because of the open-unit setting, nurses practiced bundled care and staggered their turns in the patient care area. For example, a nurse who entered to administer medication to patient A, could then receive communication to check the urine output for patient B and do so without completely doffing and redonning. This allowed preservation of PPE and reduced time in PPE for the health care providers (HCPs).

A scheduled daily meeting included staff from PACU-ICU; Medical ICU (MICU), which also treated patients with COVID-19; and the Palliative Care Service (Figure 4). Patients with single-organ failure were preferentially sent to PACU-ICU, as the ability to do renal replacement therapy (RRT) in an open unit proved difficult. The palliative care team and VAAAHS social workers assisted both MICU and PACU-ICU with communicating with patients’ families, which provided a great help during a clinically demanding time. Physical therapists increased their staffing of the ICU to specifically help with mobilization of patients with COVID-19 and acute respiratory distress syndrome, given the prolonged mechanical ventilation courses that were seen. Other consulting services frequently involved included infectious disease and nephrology.

Challenges and Solutions

Communication between staff located within the patient area and staff located in the nursing station was difficult given the loud noise generated by a PAPR and the plexiglass walls that separated the areas. Multiple techniques were attempted to overcome this. Dry erase boards were placed within the space to facilitate requests, but these were found to be time consuming. Two-way radios worked well if the users were wearing N95s but were harder to communicate when users were wearing PAPRs. Baby monitors were purchased to facilitate 2-way communication and were useful at times although quieter than desired. Vocera B3000N Communication Badges, which were already utilized in the perioperative period at the facility, could be utilized underneath PPE and were ultimately the best form of clear communication between staff within the patient care area and outside the negative pressure zone. In accordance with company guidance, these mobile devices were cleaned with virucidal wipes after use.¹⁰

Communication with patients’ families was critically important. The ICU team, palliative care team, or social workers made daily telephone calls to family members. The facility telehealth coordinator provided a designated tablet device to enable the intensivists to video conference with the patients’ families at bedside, utilizing virtual care manager appointments. This allowed families to see and interact with their loved ones despite the prohibition of family visitors. Every effort was made to utilize video calling daily; however, clinical demands as well as Internet and technological constraints from individual family members intermittently precluded video calls.

Clinical Challenges

Patients with severe COVID-19 infections requiring mechanical ventilation have proven to be exceptionally high-acuity patients with myriad organ-based complications reported.¹¹ Specific to our PACU-ICU, we determined that it was impractical to arrange for continuous RRT given the amount of training PACU nursing staff would have required and the limited ICU nursing staff in the PACU-ICU. Intermittent hemodialysis required replumbing for water supply and drainage but was ultimately not required as our facility expanded the number of continuous RRT machines available, allowing all patients in the COVID-19 ICU who required RRT to stay in the 16-bed ICU. Daily communication with the MICU allowed for safe transfer of patients with imminent needs for RRT to the MICU, providing a coordinated strategy for the deployment of scarce resources across our expanded ICU footprint.

Using anesthesia machines as ICU ventilators proved challenging, despite following best practice guidance.⁸ Notably, anesthesia machines are not actively humidified and require very high fresh gas flows, necessitating the addition of heat moisture exchangers (HME) to the circuit. Also, viral filters were placed in the circuit to prevent machine contamination. The addition of the HME and viral filters to each circuit increased the present dead space and led todifficulty in providing adequate ventilation to patients who already may have had a high proportion of physiologic dead space. The high fresh gas flows used still seemed inadequate in preventing moisture buildup in the machine parts, necessitating frequent exchanges of viral filters, HMEs, and circuits to prevent high peak airway pressures. In addition, anesthesia machines directly sample gas from the patient's breathing circuit, creating the risk for contamination of the space. This required a reconfiguration to allow for a suction scavenging system by VAAAHS biomedical engineers. Also, anesthesia machines are not designed for long-term ventilation and have different ventilation modes compared with modern ICU ventilators. Although they were used for several patients when the PACU-ICU opened, the hospital was able to acquire additional ICU ventilators, and extensive or prolonged use of anesthesia machine ventilators was avoided.

Infection Control

The open care setting provided unique infection control issues that had to be addressed.¹² The open setting allowed preservation of PPE and the ability for bundled care to be delivered easily. The VAAAHS infection control team worked closely with the ICU team to develop practices to ensure both patient and health care worker protection. Notable challenges included donning new gowns between patients when a PAPR was already being worn, leading to draping of new gowns over existing gowns when going between patients. True hand hygiene was also difficult, as health care workers did not want to completely remove gloves while in the patient care area. Layering of 2 pairs of gloves allowed the outer gloves to be removed after care of each patient, at which time alcohol gel was applied to the inner gloves, a new gown was placed over the existing gown, and a new pair of gloves was layered on top.

Although patients were intubated for long periods in the PACU-ICU, there was concern for increased risk of exposure of health care workers after extubation given the inability to contain the coughing patients within a private room. If a patient did well, they were transferred to a private room on the general medical floors within 24 hours of extubation to minimize this risk.

Privacy

The open care design meant less privacy for patients than would be provided in a private room. Curtains were drawn around patient beds as much as possible, especially for nursing care, but priority was given to visualization of the ventilator when a HCP was not present to ensure safety at all times. The majority of patients cared for in the PACU-ICU were intubated and sedated on arrival, but thankfully many were extubated. After extubation privacy in the open care area became more of an issue and may have led to more nighttime disturbances and substandard delirium prevention measures. Priority was given to expediting the transfer of these patients to private rooms on the general medical floor once their respiratory status was deemed stable.

Conclusions

The COVID-19 pandemic is truly an unprecedented event in our nation’s history, which has led to the first nationwide authorization of the fourth mission of VA to provide support for national, state, and local public health. The PACU-ICU was designed, engineered, built, and staffed by perioperative HCPs through an exceptional multidisciplinary effort in a matter of days. Through this dedication of health care workers and staff, the VAAAHS was able to care for critically ill veterans from Southeast Michigan and serve the community during a time of overwhelming demand on the national health care system.

Acknowledgments

The authors thank the outstanding team of administrators, engineers, physical therapists, pharmacists, nurses, advanced practice providers, CRNAs, respiratory therapists, and physicians who made it possible to respond to our veterans’ and our community’s needs in a time of unprecedented demand on our health care system. A special thank you to Eric Deters, Chief Strategy Officer; Brittany McClure, ICU Nurse Manager; and Mark Dotson, Chief Supply Chain Officer. It was a privilege to serve on this mission together.

A torrent of blame has deluged the administration’s management of the pandemic. There is though one part of the government that deserves the praise of the nation for its response to this public health crisis—the federal health care system. In this column, we discuss the ways in which the Veterans Health Administration (VHA), the Department of Defense (DoD), and the US Public Health Service (PHS) Commissioned Corps especially have bravely and generously responded to the medical emergency of COVID-19 in the US.

Four missions drive the US Department of Veterans Affairs (VA). Though the fourth of these missions usually is in the background, it has risen to the forefront during the pandemic. To put the fourth mission in its proper perspective, we first should review the other 3 charges given to the largest integrated health care system in the country.

The first mission is to provide the highest quality care possible for the more than 9 million veterans enrolled in that system at each of the 1,255 VHA locations. The second mission is to ensure that the Veterans Benefits Administration delivers the full range of benefits that veterans earned through their service. These including funding for education, loans for homes, and many other types of support that assist service men and women to be successful in their transition from military to civilian life. The third mission is to honor the commitment of those who fought for their country unto death. The National Cemeteries Administration oversees 142 national cemeteries where veterans are buried with dignity and remembered with gratitude for their uniformed service. The purpose of these 3 internally focused missions is to provide a safety net for eligible veterans from the day they separate from the military until the hour they pass from this earth.

The fourth mission is different. This mission looks outside the military family to the civilian world. Its goal is to bolster the ability of the nation as a whole to handle wars, terrorism, national emergencies, and natural disasters. It does this through emergency response plans that preserve the integrity of the 3 other missions to veterans while enhancing the capacity of local and state governments to manage the threat of these public health, safety, or security crises.¹

At the same time the VA was aggressively mounting a defense against the threat COVID-19 posed to the other missions, it also launched the fourth mission. In announcing these actions in April 2020, VA Secretary Robert Wilke succinctly summarized the need to balance the fourth mission with the other 3. “VA is committed to helping the nation in this effort to combat COVID-19. Helping veterans is our first mission, but in many locations across the country we’re helping states and local communities. VA is in this fight not only for the millions of veterans we serve each day; we’re in the fight for the people of the United States.”²

During the 2009 H1N1 pandemic I saw firsthand how VA disaster preparedness and emergency training were far superior to many academic and community health care systems. Given VA’s detailed and drilled crisis response plans, its specialized expertise in public health disasters, and its immense resources, it is no wonder that as the virus stretched civilian health care systems, some states turned to the VA for help. At my Albuquerque, New Mexico, VA medical center, 5 medical surgical beds and 3 intensive care beds were opened to the Indian Health Service overwhelmed with cases of COVID-19 in the hard-hit Navajo Nation. In New Jersey where Federal Practitioner is published, the fourth mission reached out to the state-run veterans homes as 90 VA nurses and gerontologists were deployed to 2 of its veterans facilities where close to 150 veterans have died.³ State veterans homes in Massachusetts, Pennsylvania, Alabama, and many other states have received supplies, including direly needed testing and personal protective equipment, staff, technology, and training.⁴

In July, VA published an impressive summary of fourth mission activities, which I encourage you to read. When you are look at this site, remember with a moment of silent appreciation all the altruistic and courageous VA clinical and administrative staff who volunteered for these assignments many of which put them directly in harm’s way.⁵

The VA is not alone in answering the call of COVID-19. In March, despite the grave risk to their health, their life, and their families, the USNS Comfort was deployed to New York City to help with its COVID-19 response while the USNS Mercy assisted in the efforts in Los Angeles. More recently, the military deployed > 700 Military Health System medical and support professionals to support COVID-19 operations in both Texas and California. Brooke Army Medical Center in San Antonio has taken on a handful of civilian patients with COVID-19 and increase its level I trauma cases as local hospitals have strained under the caseload.⁶

For the PHS Commissioned Corps its first mission is to serve as “America’s health responders.”⁷ This pandemic has intensified the extant health inequities in our country and compounded them with racial injustice and economic disparity. Thus, it is important to recognize that the very purpose of the PHS is to “fight disease, conduct research, and care for patients in underserved communities across the nation.”⁸ More than 3,900 PHS officers have been deployed nationally and internationally in COVID-19 clinical strike teams. Early in the pandemic the clinical response teams were deployed to a long-term care facility in Kirkland, Washington; convention center-based hospitals in New York City, Detroit, Michigan, and Washington DC, and Navajo Nation facilities. PHS officers also are providing clinical guidance at Bureau of Prison facilities for infection control and personal protective equipment training.

We know that there are many more examples of heroic service by federal health care professionals and staff than we could locate or celebrate in this brief column. Readers of this journal are well aware of the near constant criticism of the VA and calls for privatization,⁹ the inadequate funding of the PHS,¹⁰ and the recent downsizing of DoD health care¹¹ that threatens to undermine its core functions. The pandemic has powerfully demonstrated that degrading the ability of federal health care to agilely and masterfully mobilize in the event of a public health disaster endangers not just veterans and the military but the health and well-being of a nation, particularly its most vulnerable citizens.

A torrent of blame has deluged the administration’s management of the pandemic. There is though one part of the government that deserves the praise of the nation for its response to this public health crisis—the federal health care system. In this column, we discuss the ways in which the Veterans Health Administration (VHA), the Department of Defense (DoD), and the US Public Health Service (PHS) Commissioned Corps especially have bravely and generously responded to the medical emergency of COVID-19 in the US.

Four missions drive the US Department of Veterans Affairs (VA). Though the fourth of these missions usually is in the background, it has risen to the forefront during the pandemic. To put the fourth mission in its proper perspective, we first should review the other 3 charges given to the largest integrated health care system in the country.

The first mission is to provide the highest quality care possible for the more than 9 million veterans enrolled in that system at each of the 1,255 VHA locations. The second mission is to ensure that the Veterans Benefits Administration delivers the full range of benefits that veterans earned through their service. These including funding for education, loans for homes, and many other types of support that assist service men and women to be successful in their transition from military to civilian life. The third mission is to honor the commitment of those who fought for their country unto death. The National Cemeteries Administration oversees 142 national cemeteries where veterans are buried with dignity and remembered with gratitude for their uniformed service. The purpose of these 3 internally focused missions is to provide a safety net for eligible veterans from the day they separate from the military until the hour they pass from this earth.

The fourth mission is different. This mission looks outside the military family to the civilian world. Its goal is to bolster the ability of the nation as a whole to handle wars, terrorism, national emergencies, and natural disasters. It does this through emergency response plans that preserve the integrity of the 3 other missions to veterans while enhancing the capacity of local and state governments to manage the threat of these public health, safety, or security crises.¹

At the same time the VA was aggressively mounting a defense against the threat COVID-19 posed to the other missions, it also launched the fourth mission. In announcing these actions in April 2020, VA Secretary Robert Wilke succinctly summarized the need to balance the fourth mission with the other 3. “VA is committed to helping the nation in this effort to combat COVID-19. Helping veterans is our first mission, but in many locations across the country we’re helping states and local communities. VA is in this fight not only for the millions of veterans we serve each day; we’re in the fight for the people of the United States.”²

During the 2009 H1N1 pandemic I saw firsthand how VA disaster preparedness and emergency training were far superior to many academic and community health care systems. Given VA’s detailed and drilled crisis response plans, its specialized expertise in public health disasters, and its immense resources, it is no wonder that as the virus stretched civilian health care systems, some states turned to the VA for help. At my Albuquerque, New Mexico, VA medical center, 5 medical surgical beds and 3 intensive care beds were opened to the Indian Health Service overwhelmed with cases of COVID-19 in the hard-hit Navajo Nation. In New Jersey where Federal Practitioner is published, the fourth mission reached out to the state-run veterans homes as 90 VA nurses and gerontologists were deployed to 2 of its veterans facilities where close to 150 veterans have died.³ State veterans homes in Massachusetts, Pennsylvania, Alabama, and many other states have received supplies, including direly needed testing and personal protective equipment, staff, technology, and training.⁴

In July, VA published an impressive summary of fourth mission activities, which I encourage you to read. When you are look at this site, remember with a moment of silent appreciation all the altruistic and courageous VA clinical and administrative staff who volunteered for these assignments many of which put them directly in harm’s way.⁵

The VA is not alone in answering the call of COVID-19. In March, despite the grave risk to their health, their life, and their families, the USNS Comfort was deployed to New York City to help with its COVID-19 response while the USNS Mercy assisted in the efforts in Los Angeles. More recently, the military deployed > 700 Military Health System medical and support professionals to support COVID-19 operations in both Texas and California. Brooke Army Medical Center in San Antonio has taken on a handful of civilian patients with COVID-19 and increase its level I trauma cases as local hospitals have strained under the caseload.⁶

For the PHS Commissioned Corps its first mission is to serve as “America’s health responders.”⁷ This pandemic has intensified the extant health inequities in our country and compounded them with racial injustice and economic disparity. Thus, it is important to recognize that the very purpose of the PHS is to “fight disease, conduct research, and care for patients in underserved communities across the nation.”⁸ More than 3,900 PHS officers have been deployed nationally and internationally in COVID-19 clinical strike teams. Early in the pandemic the clinical response teams were deployed to a long-term care facility in Kirkland, Washington; convention center-based hospitals in New York City, Detroit, Michigan, and Washington DC, and Navajo Nation facilities. PHS officers also are providing clinical guidance at Bureau of Prison facilities for infection control and personal protective equipment training.

We know that there are many more examples of heroic service by federal health care professionals and staff than we could locate or celebrate in this brief column. Readers of this journal are well aware of the near constant criticism of the VA and calls for privatization,⁹ the inadequate funding of the PHS,¹⁰ and the recent downsizing of DoD health care¹¹ that threatens to undermine its core functions. The pandemic has powerfully demonstrated that degrading the ability of federal health care to agilely and masterfully mobilize in the event of a public health disaster endangers not just veterans and the military but the health and well-being of a nation, particularly its most vulnerable citizens.

A torrent of blame has deluged the administration’s management of the pandemic. There is though one part of the government that deserves the praise of the nation for its response to this public health crisis—the federal health care system. In this column, we discuss the ways in which the Veterans Health Administration (VHA), the Department of Defense (DoD), and the US Public Health Service (PHS) Commissioned Corps especially have bravely and generously responded to the medical emergency of COVID-19 in the US.

Four missions drive the US Department of Veterans Affairs (VA). Though the fourth of these missions usually is in the background, it has risen to the forefront during the pandemic. To put the fourth mission in its proper perspective, we first should review the other 3 charges given to the largest integrated health care system in the country.

The first mission is to provide the highest quality care possible for the more than 9 million veterans enrolled in that system at each of the 1,255 VHA locations. The second mission is to ensure that the Veterans Benefits Administration delivers the full range of benefits that veterans earned through their service. These including funding for education, loans for homes, and many other types of support that assist service men and women to be successful in their transition from military to civilian life. The third mission is to honor the commitment of those who fought for their country unto death. The National Cemeteries Administration oversees 142 national cemeteries where veterans are buried with dignity and remembered with gratitude for their uniformed service. The purpose of these 3 internally focused missions is to provide a safety net for eligible veterans from the day they separate from the military until the hour they pass from this earth.

The fourth mission is different. This mission looks outside the military family to the civilian world. Its goal is to bolster the ability of the nation as a whole to handle wars, terrorism, national emergencies, and natural disasters. It does this through emergency response plans that preserve the integrity of the 3 other missions to veterans while enhancing the capacity of local and state governments to manage the threat of these public health, safety, or security crises.¹

At the same time the VA was aggressively mounting a defense against the threat COVID-19 posed to the other missions, it also launched the fourth mission. In announcing these actions in April 2020, VA Secretary Robert Wilke succinctly summarized the need to balance the fourth mission with the other 3. “VA is committed to helping the nation in this effort to combat COVID-19. Helping veterans is our first mission, but in many locations across the country we’re helping states and local communities. VA is in this fight not only for the millions of veterans we serve each day; we’re in the fight for the people of the United States.”²

During the 2009 H1N1 pandemic I saw firsthand how VA disaster preparedness and emergency training were far superior to many academic and community health care systems. Given VA’s detailed and drilled crisis response plans, its specialized expertise in public health disasters, and its immense resources, it is no wonder that as the virus stretched civilian health care systems, some states turned to the VA for help. At my Albuquerque, New Mexico, VA medical center, 5 medical surgical beds and 3 intensive care beds were opened to the Indian Health Service overwhelmed with cases of COVID-19 in the hard-hit Navajo Nation. In New Jersey where Federal Practitioner is published, the fourth mission reached out to the state-run veterans homes as 90 VA nurses and gerontologists were deployed to 2 of its veterans facilities where close to 150 veterans have died.³ State veterans homes in Massachusetts, Pennsylvania, Alabama, and many other states have received supplies, including direly needed testing and personal protective equipment, staff, technology, and training.⁴

In July, VA published an impressive summary of fourth mission activities, which I encourage you to read. When you are look at this site, remember with a moment of silent appreciation all the altruistic and courageous VA clinical and administrative staff who volunteered for these assignments many of which put them directly in harm’s way.⁵

The VA is not alone in answering the call of COVID-19. In March, despite the grave risk to their health, their life, and their families, the USNS Comfort was deployed to New York City to help with its COVID-19 response while the USNS Mercy assisted in the efforts in Los Angeles. More recently, the military deployed > 700 Military Health System medical and support professionals to support COVID-19 operations in both Texas and California. Brooke Army Medical Center in San Antonio has taken on a handful of civilian patients with COVID-19 and increase its level I trauma cases as local hospitals have strained under the caseload.⁶

For the PHS Commissioned Corps its first mission is to serve as “America’s health responders.”⁷ This pandemic has intensified the extant health inequities in our country and compounded them with racial injustice and economic disparity. Thus, it is important to recognize that the very purpose of the PHS is to “fight disease, conduct research, and care for patients in underserved communities across the nation.”⁸ More than 3,900 PHS officers have been deployed nationally and internationally in COVID-19 clinical strike teams. Early in the pandemic the clinical response teams were deployed to a long-term care facility in Kirkland, Washington; convention center-based hospitals in New York City, Detroit, Michigan, and Washington DC, and Navajo Nation facilities. PHS officers also are providing clinical guidance at Bureau of Prison facilities for infection control and personal protective equipment training.

We know that there are many more examples of heroic service by federal health care professionals and staff than we could locate or celebrate in this brief column. Readers of this journal are well aware of the near constant criticism of the VA and calls for privatization,⁹ the inadequate funding of the PHS,¹⁰ and the recent downsizing of DoD health care¹¹ that threatens to undermine its core functions. The pandemic has powerfully demonstrated that degrading the ability of federal health care to agilely and masterfully mobilize in the event of a public health disaster endangers not just veterans and the military but the health and well-being of a nation, particularly its most vulnerable citizens.

A substantial decrease in hospital admissions for acute MI was accompanied by a rise in mortality, particularly for ST-segment elevation MI (STEMI), following the onset of the COVID-19 pandemic, according to a cross-sectional retrospective study.

Although it can’t be confirmed from these results that the observed increase in in-hospital acute MI (AMI) mortality are related to delays in seeking treatment, this is a reasonable working hypothesis until more is known, commented Harlan Krumholz, MD, who was not involved in the study.

The analysis, derived from data collected at 49 centers in a hospital system spread across six states, supports previous reports that patients with AMI were avoiding hospitalization, according to the investigators, who were led by Tyler J. Gluckman, MD, medical director of the Center for Cardiovascular Analytics, Providence Heart Institute, Portland, Ore.

When compared with a nearly 14-month period that preceded the COVID-19 pandemic, the rate of AMI-associated hospitalization fell by 19 cases per week (95% confidence interval, –29.0 to –9.0 cases) in the early COVID-19 period, which was defined by the investigators as spanning from Feb. 23, 2020 to March 28, 2020.

The case rate per week then increased by 10.5 (95% CI, 4.6-16.5 cases) in a subsequent 8-week period spanning between March 29, 2020, and May 16, 2020. Although a substantial increase from the early COVID-19 period, the case rate remained below the baseline established before COVID-19.

The analysis looked at 15,244 AMI hospitalizations among 14,724 patients treated in the Providence St. Joseph Hospital System, which has facilities in Alaska, California, Montana, Oregon, Texas, and Washington. The 1,915 AMI cases captured from Feb. 23, 2020, represented 13% of the total.
 

Differences in mortality, patients, treatment

In the early period, the ratio of observed-to-expected (O/E) mortality relative to the pre–COVID-19 baseline increased by 27% (odds ratio, 1.27; 95% CI, 1.07-1.48). When STEMI was analyzed separately, the O/E mortality was nearly double that of the baseline period (OR, 1.96; 95% CI, 1.22-2.70). In the latter post–COVID-19 period of observation, the overall increase in AMI-associated mortality on the basis of an O/E ratio was no longer significant relative to the baseline period (OR, 1.23; 95% CI, 0.98-1.47). However, the relative increase in STEMI-associated mortality on an O/E basis was even greater (OR, 2.40; 95% CI, 1.65-3.16) in the second COVID-19 period analyzed. Even after risk adjustment, the OR for STEMI mortality remained significantly elevated relative to baseline (1.52; 95% CI, 1.02-2.26).

The differences in AMI patients treated before the onset of the COVID-19 pandemic and those treated afterwards might be relevant, according to the investigators. Specifically, patients hospitalized after Feb. 23, 2020 were 1-3 years younger (P < .001) depending on type of AMI, and more likely to be Asian (P = .01).

The length of stay was 6 hours shorter in the early COVID-19 period and 7 hours shorter in the latter period relative to baseline, but an analysis of treatment approaches to non-STEMI and STEMI during the COVID-19 pandemic were not found to be significantly different from baseline.

Prior to the COVID-19 pandemic, 79% of STEMI patients and 77% of non-STEMI patients were discharged home, which was significantly lower than in the early COVID-19 period, when 83% (P = .02) of STEMI and 81% (P = .006) of non-STEMI patients were discharged home. In the latter period, discharge to home care was also significantly higher than in the baseline period.
 

More than fear of COVID-19?

One theory to account for the reduction in AMI hospitalizations and the increase in AMI-related mortality is the possibility that patients were slow to seek care at acute care hospitals because of concern about COVID-19 infection, according to Dr. Gluckman and coinvestigators.

“Given the time-sensitive nature of STEMI, any delay by patients, emergency medical services, the emergency department, or cardiac catheterization laboratory may have played a role,” they suggested.

In an interview, Dr. Gluckman said that further effort to identify the reasons for the increased AMI-related mortality is planned. Pulling data from the electronic medical records of the patients included in this retrospective analysis might be a “challenge,” but Dr. Gluckman reported that he and his coinvestigators plan to look at a different set of registry data that might provide information on sources of delay, particularly in the STEMI population.

“This includes looking at a number of time factors, such as symptom onset to first medical contact, first medical contact to device, and door-in-door-out times,” Dr. Gluckman said. The goal is to “better understand if delays [in treatment] occurred during the pandemic and, if so, how they may have contributed to increases in risk adjusted mortality.”

Dr. Krumholz, director of the Yale Center for Outcomes Research and Evaluation, New Haven, Conn., called this study a “useful” confirmation of changes in AMI-related care with the onset of the COVID-19 pandemic. As reported anecdotally, the study “indicates marked decreases in hospitalizations of patients with AMI even in areas that were not experiencing big outbreaks but did have some restrictions to limit spread,” he noted.

More data gathered by other centers might provide information about what it all means.

“There remain so many questions about what happened and what consequences accrued,” Dr. Krumholz observed. “In the meantime, we need to continue to send the message that people with symptoms that suggest a heart attack need to rapidly seek care.”

The investigators reported having no financial conflicts of interest.

SOURCE: Gluckman TJ et al. JAMA Cardiol. 2020 Aug 7. doi: 10.1001/jamacardio.2020.3629.

A substantial decrease in hospital admissions for acute MI was accompanied by a rise in mortality, particularly for ST-segment elevation MI (STEMI), following the onset of the COVID-19 pandemic, according to a cross-sectional retrospective study.

Although it can’t be confirmed from these results that the observed increase in in-hospital acute MI (AMI) mortality are related to delays in seeking treatment, this is a reasonable working hypothesis until more is known, commented Harlan Krumholz, MD, who was not involved in the study.

The analysis, derived from data collected at 49 centers in a hospital system spread across six states, supports previous reports that patients with AMI were avoiding hospitalization, according to the investigators, who were led by Tyler J. Gluckman, MD, medical director of the Center for Cardiovascular Analytics, Providence Heart Institute, Portland, Ore.

When compared with a nearly 14-month period that preceded the COVID-19 pandemic, the rate of AMI-associated hospitalization fell by 19 cases per week (95% confidence interval, –29.0 to –9.0 cases) in the early COVID-19 period, which was defined by the investigators as spanning from Feb. 23, 2020 to March 28, 2020.

The case rate per week then increased by 10.5 (95% CI, 4.6-16.5 cases) in a subsequent 8-week period spanning between March 29, 2020, and May 16, 2020. Although a substantial increase from the early COVID-19 period, the case rate remained below the baseline established before COVID-19.

The analysis looked at 15,244 AMI hospitalizations among 14,724 patients treated in the Providence St. Joseph Hospital System, which has facilities in Alaska, California, Montana, Oregon, Texas, and Washington. The 1,915 AMI cases captured from Feb. 23, 2020, represented 13% of the total.
 

Differences in mortality, patients, treatment

In the early period, the ratio of observed-to-expected (O/E) mortality relative to the pre–COVID-19 baseline increased by 27% (odds ratio, 1.27; 95% CI, 1.07-1.48). When STEMI was analyzed separately, the O/E mortality was nearly double that of the baseline period (OR, 1.96; 95% CI, 1.22-2.70). In the latter post–COVID-19 period of observation, the overall increase in AMI-associated mortality on the basis of an O/E ratio was no longer significant relative to the baseline period (OR, 1.23; 95% CI, 0.98-1.47). However, the relative increase in STEMI-associated mortality on an O/E basis was even greater (OR, 2.40; 95% CI, 1.65-3.16) in the second COVID-19 period analyzed. Even after risk adjustment, the OR for STEMI mortality remained significantly elevated relative to baseline (1.52; 95% CI, 1.02-2.26).

The differences in AMI patients treated before the onset of the COVID-19 pandemic and those treated afterwards might be relevant, according to the investigators. Specifically, patients hospitalized after Feb. 23, 2020 were 1-3 years younger (P < .001) depending on type of AMI, and more likely to be Asian (P = .01).

The length of stay was 6 hours shorter in the early COVID-19 period and 7 hours shorter in the latter period relative to baseline, but an analysis of treatment approaches to non-STEMI and STEMI during the COVID-19 pandemic were not found to be significantly different from baseline.

Prior to the COVID-19 pandemic, 79% of STEMI patients and 77% of non-STEMI patients were discharged home, which was significantly lower than in the early COVID-19 period, when 83% (P = .02) of STEMI and 81% (P = .006) of non-STEMI patients were discharged home. In the latter period, discharge to home care was also significantly higher than in the baseline period.
 

More than fear of COVID-19?

One theory to account for the reduction in AMI hospitalizations and the increase in AMI-related mortality is the possibility that patients were slow to seek care at acute care hospitals because of concern about COVID-19 infection, according to Dr. Gluckman and coinvestigators.

“Given the time-sensitive nature of STEMI, any delay by patients, emergency medical services, the emergency department, or cardiac catheterization laboratory may have played a role,” they suggested.

In an interview, Dr. Gluckman said that further effort to identify the reasons for the increased AMI-related mortality is planned. Pulling data from the electronic medical records of the patients included in this retrospective analysis might be a “challenge,” but Dr. Gluckman reported that he and his coinvestigators plan to look at a different set of registry data that might provide information on sources of delay, particularly in the STEMI population.

“This includes looking at a number of time factors, such as symptom onset to first medical contact, first medical contact to device, and door-in-door-out times,” Dr. Gluckman said. The goal is to “better understand if delays [in treatment] occurred during the pandemic and, if so, how they may have contributed to increases in risk adjusted mortality.”

Dr. Krumholz, director of the Yale Center for Outcomes Research and Evaluation, New Haven, Conn., called this study a “useful” confirmation of changes in AMI-related care with the onset of the COVID-19 pandemic. As reported anecdotally, the study “indicates marked decreases in hospitalizations of patients with AMI even in areas that were not experiencing big outbreaks but did have some restrictions to limit spread,” he noted.

More data gathered by other centers might provide information about what it all means.

“There remain so many questions about what happened and what consequences accrued,” Dr. Krumholz observed. “In the meantime, we need to continue to send the message that people with symptoms that suggest a heart attack need to rapidly seek care.”

The investigators reported having no financial conflicts of interest.

SOURCE: Gluckman TJ et al. JAMA Cardiol. 2020 Aug 7. doi: 10.1001/jamacardio.2020.3629.

A substantial decrease in hospital admissions for acute MI was accompanied by a rise in mortality, particularly for ST-segment elevation MI (STEMI), following the onset of the COVID-19 pandemic, according to a cross-sectional retrospective study.

Although it can’t be confirmed from these results that the observed increase in in-hospital acute MI (AMI) mortality are related to delays in seeking treatment, this is a reasonable working hypothesis until more is known, commented Harlan Krumholz, MD, who was not involved in the study.

The analysis, derived from data collected at 49 centers in a hospital system spread across six states, supports previous reports that patients with AMI were avoiding hospitalization, according to the investigators, who were led by Tyler J. Gluckman, MD, medical director of the Center for Cardiovascular Analytics, Providence Heart Institute, Portland, Ore.

When compared with a nearly 14-month period that preceded the COVID-19 pandemic, the rate of AMI-associated hospitalization fell by 19 cases per week (95% confidence interval, –29.0 to –9.0 cases) in the early COVID-19 period, which was defined by the investigators as spanning from Feb. 23, 2020 to March 28, 2020.

The case rate per week then increased by 10.5 (95% CI, 4.6-16.5 cases) in a subsequent 8-week period spanning between March 29, 2020, and May 16, 2020. Although a substantial increase from the early COVID-19 period, the case rate remained below the baseline established before COVID-19.

The analysis looked at 15,244 AMI hospitalizations among 14,724 patients treated in the Providence St. Joseph Hospital System, which has facilities in Alaska, California, Montana, Oregon, Texas, and Washington. The 1,915 AMI cases captured from Feb. 23, 2020, represented 13% of the total.
 

Differences in mortality, patients, treatment

In the early period, the ratio of observed-to-expected (O/E) mortality relative to the pre–COVID-19 baseline increased by 27% (odds ratio, 1.27; 95% CI, 1.07-1.48). When STEMI was analyzed separately, the O/E mortality was nearly double that of the baseline period (OR, 1.96; 95% CI, 1.22-2.70). In the latter post–COVID-19 period of observation, the overall increase in AMI-associated mortality on the basis of an O/E ratio was no longer significant relative to the baseline period (OR, 1.23; 95% CI, 0.98-1.47). However, the relative increase in STEMI-associated mortality on an O/E basis was even greater (OR, 2.40; 95% CI, 1.65-3.16) in the second COVID-19 period analyzed. Even after risk adjustment, the OR for STEMI mortality remained significantly elevated relative to baseline (1.52; 95% CI, 1.02-2.26).

The differences in AMI patients treated before the onset of the COVID-19 pandemic and those treated afterwards might be relevant, according to the investigators. Specifically, patients hospitalized after Feb. 23, 2020 were 1-3 years younger (P < .001) depending on type of AMI, and more likely to be Asian (P = .01).

The length of stay was 6 hours shorter in the early COVID-19 period and 7 hours shorter in the latter period relative to baseline, but an analysis of treatment approaches to non-STEMI and STEMI during the COVID-19 pandemic were not found to be significantly different from baseline.

Prior to the COVID-19 pandemic, 79% of STEMI patients and 77% of non-STEMI patients were discharged home, which was significantly lower than in the early COVID-19 period, when 83% (P = .02) of STEMI and 81% (P = .006) of non-STEMI patients were discharged home. In the latter period, discharge to home care was also significantly higher than in the baseline period.
 

More than fear of COVID-19?

One theory to account for the reduction in AMI hospitalizations and the increase in AMI-related mortality is the possibility that patients were slow to seek care at acute care hospitals because of concern about COVID-19 infection, according to Dr. Gluckman and coinvestigators.

“Given the time-sensitive nature of STEMI, any delay by patients, emergency medical services, the emergency department, or cardiac catheterization laboratory may have played a role,” they suggested.

In an interview, Dr. Gluckman said that further effort to identify the reasons for the increased AMI-related mortality is planned. Pulling data from the electronic medical records of the patients included in this retrospective analysis might be a “challenge,” but Dr. Gluckman reported that he and his coinvestigators plan to look at a different set of registry data that might provide information on sources of delay, particularly in the STEMI population.

“This includes looking at a number of time factors, such as symptom onset to first medical contact, first medical contact to device, and door-in-door-out times,” Dr. Gluckman said. The goal is to “better understand if delays [in treatment] occurred during the pandemic and, if so, how they may have contributed to increases in risk adjusted mortality.”

Dr. Krumholz, director of the Yale Center for Outcomes Research and Evaluation, New Haven, Conn., called this study a “useful” confirmation of changes in AMI-related care with the onset of the COVID-19 pandemic. As reported anecdotally, the study “indicates marked decreases in hospitalizations of patients with AMI even in areas that were not experiencing big outbreaks but did have some restrictions to limit spread,” he noted.

More data gathered by other centers might provide information about what it all means.

“There remain so many questions about what happened and what consequences accrued,” Dr. Krumholz observed. “In the meantime, we need to continue to send the message that people with symptoms that suggest a heart attack need to rapidly seek care.”

The investigators reported having no financial conflicts of interest.

SOURCE: Gluckman TJ et al. JAMA Cardiol. 2020 Aug 7. doi: 10.1001/jamacardio.2020.3629.

An experimental cell-collection device that can be administered without anesthesia in a primary care practice was shown to be better at detecting Barrett esophagus than the standard of care in a community-based clinical trial.

Use of this patient-swallowed device, called Cytosponge-TFF3, could allow clinicians to diagnose esophageal conditions such as dysplasia or cancer at an earlier and potentially curable stage, said the investigators. However, it would also increase the likelihood of unnecessary endoscopies, owing to false-positive results.

“In this multicenter, pragmatic, randomized controlled trial we found that an invitation to have a Cytosponge-TFF3 test led to increased diagnosis of Barrett’s esophagus when compared with usual care by general practitioners,” write Rebecca C. Fitzgerald, MD, from the Hutchison/MRC Research Center in Cambridge, England, and colleagues.

The study was published online on Aug. 1 in The Lancet.

“This is a very important study, a landmark study,” said Stephen J. Meltzer, MD, professor of medicine and oncology at Johns Hopkins University, Baltimore, who was approached for comment.

“What it shows is that if you opt to have this procedure, you’re much more likely to have your Barrett’s diagnosed than if you don’t opt to have it,” he said.

He congratulated Dr. Fitzgerald and colleagues for successful completion of a large, primary practice–based clinical utility study.

“Those studies are very difficult to do. This is looking at the actual impact of an intervention, which is the sponge,” he said in an interview.

Soaking up cells

Dr. Meltzer was senior author of a case-control study published in 2019 in Clinical Cancer Research that described use of a similar device. As previously reported, that device, called EsophaCap, uses a “methylation on bead” technique to collect DNA on a swallowed sponge. The DNA is then extracted from the sponge and analyzed with a methylation biomarker panel.

Like the EsophaCap device, the Cytosponge-TFF3 device consists of a compressed, gelatin-coated collection sponge attached to a thread. The patient swallows the device. After the gelatin dissolves and the sponge expands, it is gently withdrawn through the esophagus, picking up cells as it passes through.

The collected cells are then analyzed with an in vitro test for biomarker trefoil factor 3 (TFF3), a sign of intestinal metaplasia that is a histopathologic hallmark of Barrett esophagus, the authors explained.

Cytosponge-TFF3 study

The study by Dr. Fitzgerald and colleagues was conducted in patients taking medications for gastroesophageal reflux. The patients were undergoing treatment at 109 general practice clinics in England.

Eligible patients included adults aged 50 years and older who had been taking acid-suppressing medication for gastroesophageal reflux for more than 6 months and had not undergone endoscopy within the previous 5 years.

The study was randomized at both the clinic level (cluster randomization) and the individual patient level. Patients were assigned to either standard management of gastroesophageal reflux, with endoscopies performed only if recommended by the practitioner, or to the intervention group, where individuals received usual care and were offered the Cytosponge-TFF3 procedure. Those patients whose samples yielded TFF3-positive cells subsequently underwent endoscopy.

Among 6,834 patients assigned to the intervention group, 2,679 (39%) expressed willingness to undergo the Cytosponge-TFF3 procedure. Of this group, 1,750 patients met all of the eligibility criteria on telephone screening and underwent the procedure.

The large majority of patients (95%) who agreed to undergo the procedure were able to swallow the capsule and the attached thread.

Patients in the intervention group who declined the Cytosponge-TFF3 and all patients assigned to the usual-care arm underwent endoscopy only at the recommendation of their primary practitioner.

During a mean follow-up of 12 months, 140 of the 6,834 patients in the intervention group (2%) were diagnosed with Barrett esophagus, compared with 13 of 6,388 patients in the usual-care group (0.2%). The absolute difference per 1000 person-years, the trial’s primary endpoint, was 18.3. The rate ratio adjusted for cluster randomization was 10.6 (P < .001).

A total of four patients in the intervention group were diagnosed with dysplastic Barrett esophagus, and five were diagnosed with stage I esophagogastric cancer. No patients in the usual-care group were diagnosed with either condition.

Of the 1,654 patients in the intervention group who opted for the Cytosponge device and swallowed it successfully, 221 underwent endoscopy after testing positive for TFF3. Of these patients, 131 (59%) were diagnosed with either Barrett esophagus or cancer.

The most common adverse event with the Cytosponge procedure was sore throat, reported by 4% of those who opted for it. In one patient, the thread became detach from the Cytopsonge, necessitating endoscopy to remove the device.

Promising, but refinements needed

In an editorial accompanying the study, Yuri Hanada, MD, and Kenneth K. Wang, MD, from the department of gastroenterology at the Mayo Clinic in Rochester, Minn., said that the Cytosponge-TFF3 procedure “is a promising nonendoscopic screening tool and will represent a component in the screening for Barrett’s esophagus and esophagogastric cancer.”

They noted, however, that it is unlikely to be the sole screening tool for Barrett esophagus and that its use in primary practice may be problematic during the COVID-19 pandemic, because of the release of aerosolized particles as the sponge is withdrawn from the esophagus.

“It might also be necessary to enrich disease prevalence in the screened population by limiting this population to males and people with other risk factors, in order to make this test more cost-effective than previously shown,” they wrote.

Acceptance rate low?

Dr. Meltzer noted that, despite being less invasive than endoscopy, only 39% of the group who could try it agreed to do so.

“It was kind of surprising, because in my experience, when I offer it to my patients, the acceptance is much higher, but that’s not in a controlled clinical trial situation, so I don’t really know what the true percentage is,” he said.

He pointed out that the patients he sees in his clinic are more likely to be symptomatic and highly motivated to accept a test, in contrast to the general patient population in the study.

He also noted that the endoscopy-confirmed prevalence rate of Barrett esophagus or cancer in 221 patients in the intervention group was 59%, suggesting that 41% underwent an unnecessary endoscopy after the Cytosponge screening.

Dr. Fitzgerald and colleagues acknowledged the potential for overdiagnosis with screening. They noted a debate as to whether 1 cm or short segments of Barrett esophagus are a cause for clinical concern.

They also note that the TFF3 test (used in the CytoSponge device) is sensitive and detects some short segments of Barrett esophagus and that, “since this was a pragmatic trial that relied on a coded diagnosis of Barrett’s esophagus, we also identified patients in the usual care group who had short segments of Barrett’s esophagus (1 cm or less in length) and were diagnosed as having the condition, reflecting the variable practice in U.K. hospitals.

“We expect that these patients can be reassured and probably do not require surveillance,” they continued. “This expectation is consistent with the clinical guidelines, which suggest that patients with over 1 cm of salmon-colored epithelium containing intestinal metaplasia should be monitored.”

The study was funded by Cancer Research UK, the U.K. National Institute for Health Research, the U.K. National Health Service, Medtronic, and the Medical Research Council. Dr. Fitzgerald is named on patents related to the Cytosponge-TFF3 test. Dr. Meltzer has cofounded a company, Capsulomics, to commercialize the methylation biomarker panel used in EsophaCap studies. Dr. Wang has received research funding from eNose for research on a device used in a screening study of Barrett esophagus.

This article first appeared on Medscape.com.

An experimental cell-collection device that can be administered without anesthesia in a primary care practice was shown to be better at detecting Barrett esophagus than the standard of care in a community-based clinical trial.

Use of this patient-swallowed device, called Cytosponge-TFF3, could allow clinicians to diagnose esophageal conditions such as dysplasia or cancer at an earlier and potentially curable stage, said the investigators. However, it would also increase the likelihood of unnecessary endoscopies, owing to false-positive results.

“In this multicenter, pragmatic, randomized controlled trial we found that an invitation to have a Cytosponge-TFF3 test led to increased diagnosis of Barrett’s esophagus when compared with usual care by general practitioners,” write Rebecca C. Fitzgerald, MD, from the Hutchison/MRC Research Center in Cambridge, England, and colleagues.

The study was published online on Aug. 1 in The Lancet.

“This is a very important study, a landmark study,” said Stephen J. Meltzer, MD, professor of medicine and oncology at Johns Hopkins University, Baltimore, who was approached for comment.

“What it shows is that if you opt to have this procedure, you’re much more likely to have your Barrett’s diagnosed than if you don’t opt to have it,” he said.

He congratulated Dr. Fitzgerald and colleagues for successful completion of a large, primary practice–based clinical utility study.

“Those studies are very difficult to do. This is looking at the actual impact of an intervention, which is the sponge,” he said in an interview.

Soaking up cells

Dr. Meltzer was senior author of a case-control study published in 2019 in Clinical Cancer Research that described use of a similar device. As previously reported, that device, called EsophaCap, uses a “methylation on bead” technique to collect DNA on a swallowed sponge. The DNA is then extracted from the sponge and analyzed with a methylation biomarker panel.

Like the EsophaCap device, the Cytosponge-TFF3 device consists of a compressed, gelatin-coated collection sponge attached to a thread. The patient swallows the device. After the gelatin dissolves and the sponge expands, it is gently withdrawn through the esophagus, picking up cells as it passes through.

The collected cells are then analyzed with an in vitro test for biomarker trefoil factor 3 (TFF3), a sign of intestinal metaplasia that is a histopathologic hallmark of Barrett esophagus, the authors explained.

Cytosponge-TFF3 study

The study by Dr. Fitzgerald and colleagues was conducted in patients taking medications for gastroesophageal reflux. The patients were undergoing treatment at 109 general practice clinics in England.

Eligible patients included adults aged 50 years and older who had been taking acid-suppressing medication for gastroesophageal reflux for more than 6 months and had not undergone endoscopy within the previous 5 years.

The study was randomized at both the clinic level (cluster randomization) and the individual patient level. Patients were assigned to either standard management of gastroesophageal reflux, with endoscopies performed only if recommended by the practitioner, or to the intervention group, where individuals received usual care and were offered the Cytosponge-TFF3 procedure. Those patients whose samples yielded TFF3-positive cells subsequently underwent endoscopy.

Among 6,834 patients assigned to the intervention group, 2,679 (39%) expressed willingness to undergo the Cytosponge-TFF3 procedure. Of this group, 1,750 patients met all of the eligibility criteria on telephone screening and underwent the procedure.

The large majority of patients (95%) who agreed to undergo the procedure were able to swallow the capsule and the attached thread.

Patients in the intervention group who declined the Cytosponge-TFF3 and all patients assigned to the usual-care arm underwent endoscopy only at the recommendation of their primary practitioner.

During a mean follow-up of 12 months, 140 of the 6,834 patients in the intervention group (2%) were diagnosed with Barrett esophagus, compared with 13 of 6,388 patients in the usual-care group (0.2%). The absolute difference per 1000 person-years, the trial’s primary endpoint, was 18.3. The rate ratio adjusted for cluster randomization was 10.6 (P < .001).

A total of four patients in the intervention group were diagnosed with dysplastic Barrett esophagus, and five were diagnosed with stage I esophagogastric cancer. No patients in the usual-care group were diagnosed with either condition.

Of the 1,654 patients in the intervention group who opted for the Cytosponge device and swallowed it successfully, 221 underwent endoscopy after testing positive for TFF3. Of these patients, 131 (59%) were diagnosed with either Barrett esophagus or cancer.

The most common adverse event with the Cytosponge procedure was sore throat, reported by 4% of those who opted for it. In one patient, the thread became detach from the Cytopsonge, necessitating endoscopy to remove the device.

Promising, but refinements needed

In an editorial accompanying the study, Yuri Hanada, MD, and Kenneth K. Wang, MD, from the department of gastroenterology at the Mayo Clinic in Rochester, Minn., said that the Cytosponge-TFF3 procedure “is a promising nonendoscopic screening tool and will represent a component in the screening for Barrett’s esophagus and esophagogastric cancer.”

They noted, however, that it is unlikely to be the sole screening tool for Barrett esophagus and that its use in primary practice may be problematic during the COVID-19 pandemic, because of the release of aerosolized particles as the sponge is withdrawn from the esophagus.

“It might also be necessary to enrich disease prevalence in the screened population by limiting this population to males and people with other risk factors, in order to make this test more cost-effective than previously shown,” they wrote.

Acceptance rate low?

Dr. Meltzer noted that, despite being less invasive than endoscopy, only 39% of the group who could try it agreed to do so.

“It was kind of surprising, because in my experience, when I offer it to my patients, the acceptance is much higher, but that’s not in a controlled clinical trial situation, so I don’t really know what the true percentage is,” he said.

He pointed out that the patients he sees in his clinic are more likely to be symptomatic and highly motivated to accept a test, in contrast to the general patient population in the study.

He also noted that the endoscopy-confirmed prevalence rate of Barrett esophagus or cancer in 221 patients in the intervention group was 59%, suggesting that 41% underwent an unnecessary endoscopy after the Cytosponge screening.

Dr. Fitzgerald and colleagues acknowledged the potential for overdiagnosis with screening. They noted a debate as to whether 1 cm or short segments of Barrett esophagus are a cause for clinical concern.

They also note that the TFF3 test (used in the CytoSponge device) is sensitive and detects some short segments of Barrett esophagus and that, “since this was a pragmatic trial that relied on a coded diagnosis of Barrett’s esophagus, we also identified patients in the usual care group who had short segments of Barrett’s esophagus (1 cm or less in length) and were diagnosed as having the condition, reflecting the variable practice in U.K. hospitals.

“We expect that these patients can be reassured and probably do not require surveillance,” they continued. “This expectation is consistent with the clinical guidelines, which suggest that patients with over 1 cm of salmon-colored epithelium containing intestinal metaplasia should be monitored.”

The study was funded by Cancer Research UK, the U.K. National Institute for Health Research, the U.K. National Health Service, Medtronic, and the Medical Research Council. Dr. Fitzgerald is named on patents related to the Cytosponge-TFF3 test. Dr. Meltzer has cofounded a company, Capsulomics, to commercialize the methylation biomarker panel used in EsophaCap studies. Dr. Wang has received research funding from eNose for research on a device used in a screening study of Barrett esophagus.

This article first appeared on Medscape.com.

An experimental cell-collection device that can be administered without anesthesia in a primary care practice was shown to be better at detecting Barrett esophagus than the standard of care in a community-based clinical trial.

Use of this patient-swallowed device, called Cytosponge-TFF3, could allow clinicians to diagnose esophageal conditions such as dysplasia or cancer at an earlier and potentially curable stage, said the investigators. However, it would also increase the likelihood of unnecessary endoscopies, owing to false-positive results.

“In this multicenter, pragmatic, randomized controlled trial we found that an invitation to have a Cytosponge-TFF3 test led to increased diagnosis of Barrett’s esophagus when compared with usual care by general practitioners,” write Rebecca C. Fitzgerald, MD, from the Hutchison/MRC Research Center in Cambridge, England, and colleagues.

The study was published online on Aug. 1 in The Lancet.

“This is a very important study, a landmark study,” said Stephen J. Meltzer, MD, professor of medicine and oncology at Johns Hopkins University, Baltimore, who was approached for comment.

“What it shows is that if you opt to have this procedure, you’re much more likely to have your Barrett’s diagnosed than if you don’t opt to have it,” he said.

He congratulated Dr. Fitzgerald and colleagues for successful completion of a large, primary practice–based clinical utility study.

“Those studies are very difficult to do. This is looking at the actual impact of an intervention, which is the sponge,” he said in an interview.

Soaking up cells

Dr. Meltzer was senior author of a case-control study published in 2019 in Clinical Cancer Research that described use of a similar device. As previously reported, that device, called EsophaCap, uses a “methylation on bead” technique to collect DNA on a swallowed sponge. The DNA is then extracted from the sponge and analyzed with a methylation biomarker panel.

Like the EsophaCap device, the Cytosponge-TFF3 device consists of a compressed, gelatin-coated collection sponge attached to a thread. The patient swallows the device. After the gelatin dissolves and the sponge expands, it is gently withdrawn through the esophagus, picking up cells as it passes through.

The collected cells are then analyzed with an in vitro test for biomarker trefoil factor 3 (TFF3), a sign of intestinal metaplasia that is a histopathologic hallmark of Barrett esophagus, the authors explained.

Cytosponge-TFF3 study

The study by Dr. Fitzgerald and colleagues was conducted in patients taking medications for gastroesophageal reflux. The patients were undergoing treatment at 109 general practice clinics in England.

Eligible patients included adults aged 50 years and older who had been taking acid-suppressing medication for gastroesophageal reflux for more than 6 months and had not undergone endoscopy within the previous 5 years.

The study was randomized at both the clinic level (cluster randomization) and the individual patient level. Patients were assigned to either standard management of gastroesophageal reflux, with endoscopies performed only if recommended by the practitioner, or to the intervention group, where individuals received usual care and were offered the Cytosponge-TFF3 procedure. Those patients whose samples yielded TFF3-positive cells subsequently underwent endoscopy.

Among 6,834 patients assigned to the intervention group, 2,679 (39%) expressed willingness to undergo the Cytosponge-TFF3 procedure. Of this group, 1,750 patients met all of the eligibility criteria on telephone screening and underwent the procedure.

The large majority of patients (95%) who agreed to undergo the procedure were able to swallow the capsule and the attached thread.

Patients in the intervention group who declined the Cytosponge-TFF3 and all patients assigned to the usual-care arm underwent endoscopy only at the recommendation of their primary practitioner.

During a mean follow-up of 12 months, 140 of the 6,834 patients in the intervention group (2%) were diagnosed with Barrett esophagus, compared with 13 of 6,388 patients in the usual-care group (0.2%). The absolute difference per 1000 person-years, the trial’s primary endpoint, was 18.3. The rate ratio adjusted for cluster randomization was 10.6 (P < .001).

A total of four patients in the intervention group were diagnosed with dysplastic Barrett esophagus, and five were diagnosed with stage I esophagogastric cancer. No patients in the usual-care group were diagnosed with either condition.

Of the 1,654 patients in the intervention group who opted for the Cytosponge device and swallowed it successfully, 221 underwent endoscopy after testing positive for TFF3. Of these patients, 131 (59%) were diagnosed with either Barrett esophagus or cancer.

The most common adverse event with the Cytosponge procedure was sore throat, reported by 4% of those who opted for it. In one patient, the thread became detach from the Cytopsonge, necessitating endoscopy to remove the device.

Promising, but refinements needed

In an editorial accompanying the study, Yuri Hanada, MD, and Kenneth K. Wang, MD, from the department of gastroenterology at the Mayo Clinic in Rochester, Minn., said that the Cytosponge-TFF3 procedure “is a promising nonendoscopic screening tool and will represent a component in the screening for Barrett’s esophagus and esophagogastric cancer.”

They noted, however, that it is unlikely to be the sole screening tool for Barrett esophagus and that its use in primary practice may be problematic during the COVID-19 pandemic, because of the release of aerosolized particles as the sponge is withdrawn from the esophagus.

“It might also be necessary to enrich disease prevalence in the screened population by limiting this population to males and people with other risk factors, in order to make this test more cost-effective than previously shown,” they wrote.

Acceptance rate low?

Dr. Meltzer noted that, despite being less invasive than endoscopy, only 39% of the group who could try it agreed to do so.

“It was kind of surprising, because in my experience, when I offer it to my patients, the acceptance is much higher, but that’s not in a controlled clinical trial situation, so I don’t really know what the true percentage is,” he said.

He pointed out that the patients he sees in his clinic are more likely to be symptomatic and highly motivated to accept a test, in contrast to the general patient population in the study.

He also noted that the endoscopy-confirmed prevalence rate of Barrett esophagus or cancer in 221 patients in the intervention group was 59%, suggesting that 41% underwent an unnecessary endoscopy after the Cytosponge screening.

Dr. Fitzgerald and colleagues acknowledged the potential for overdiagnosis with screening. They noted a debate as to whether 1 cm or short segments of Barrett esophagus are a cause for clinical concern.

They also note that the TFF3 test (used in the CytoSponge device) is sensitive and detects some short segments of Barrett esophagus and that, “since this was a pragmatic trial that relied on a coded diagnosis of Barrett’s esophagus, we also identified patients in the usual care group who had short segments of Barrett’s esophagus (1 cm or less in length) and were diagnosed as having the condition, reflecting the variable practice in U.K. hospitals.

“We expect that these patients can be reassured and probably do not require surveillance,” they continued. “This expectation is consistent with the clinical guidelines, which suggest that patients with over 1 cm of salmon-colored epithelium containing intestinal metaplasia should be monitored.”

The study was funded by Cancer Research UK, the U.K. National Institute for Health Research, the U.K. National Health Service, Medtronic, and the Medical Research Council. Dr. Fitzgerald is named on patents related to the Cytosponge-TFF3 test. Dr. Meltzer has cofounded a company, Capsulomics, to commercialize the methylation biomarker panel used in EsophaCap studies. Dr. Wang has received research funding from eNose for research on a device used in a screening study of Barrett esophagus.

This article first appeared on Medscape.com.

A deep learning (DL) computer model improved upon the accuracy of cervical cancer diagnoses compared to traditional radiology. This could allow some women to avoid surgery and be treated with chemotherapy instead, suggested researchers.

The model mined tumor information from pelvic sagittal contrast-enhanced T1-weighted MRIs and combined this with clinical MRI lymph node status.

It was 90.62% sensitive and 87.16% specific for predicting lymph node metastases (LNMs) in a validation cohort of women who underwent surgery for cervical cancer.

The area under the curve was 0.933. The approach was significantly associated with disease-free survival (hazard ratio, 4.59; 95% confidence interval, 2.04-10.31; P < .001).

The study was published online on July 24 in JAMA Network Open.

“The findings of this study suggest that deep learning can be used as a preoperative noninvasive tool to diagnose lymph node metastasis in cervical cancer ... This model might be used preoperatively to help gynecologists make decisions,” said investigators led by Qingxia Wu, PhD, of the Northeastern University College of Medicine and Biomedical Information Engineering in Shenyang, China.

“Studies like these suggest that deep learning has the potential to improve the way we care for our patients,” but there’s much to be done “before these types of algorithms will be commonplace,” commented Christiaan Rees, MD, PhD, an internal medicine resident at Brigham and Women’s Hospital, Boston, who has a doctorate in quantitative biomedical sciences.

Next steps include repeated validation across multiple control groups, he said in an interview, as well as “finding ways to effectively integrate these tools into the radiologist’s day-to-day practice. One possibility would be for direct integration of the algorithm into the electronic health record.”
 

Accurate prediction could lead to skipping surgery

Chemotherapy, rather than surgery, is an option for women with positive lymph nodes (LNs), so accurate prediction can help them avoid an operation and its risks, the authors said.

The problem is that “the traditional methods for assessing LN status in cervical cancer, which rely mainly on assessing the size of LNs on MRI, have limited sensitivity in diagnosing LNM in cervical cancer and might lead to inappropriate treatment decisions,” they wrote.

“Although sentinel LN dissection ... shows good sensitivity and specificity, its application is limited by available facilities and experts,” the team said.

DL is an advanced form of artificial intelligence in which a computer program continuously improves on a given task as it incorporates more data – in Dr. Wu’s study, more than 14 million images. Deep learning has recently shown promise in several imaging tasks, such as diagnosing Alzheimer’s disease and screening for breast cancer.

Once adapted for cervical cancer, DL “does not require precise tumor delineation, making it an easy-to-use method in clinical practice. In many tumor analysis tasks, DL outperforms traditional radiomic features,” the team noted.

The study involved 479 women – 338 during model development, and 141 in the validation cohorts. The mean age of the participants was 49.1 years. They had undergone radical hysterectomy with pelvic lymphadenectomy for stage IB-IIB cervical cancer within 2 weeks of a pelvic MRI. Pathology reports were used to check the accuracy of the model’s predictions.

Specificity, sensitivity, and area under the curve were a little better in the study’s development cohort than its validation group, for whom median disease-free survival was 23 months versus 31 months among the patients in the development cohort. Nodes were positive on lymphadenectomy in a little more than 20% of women in both groups.

Incorporation of both intratumoral and peritumoral regions on contrast-enhanced T1-weighted MRIs versus axial T2-weighted and axial diffusion-weighted imaging, produced the highest sensitivity. Adding MRI-LN status – defined as positive when the short-axis diameter of the largest LN on MRI was ≥1 cm – improved the model’s specificity.

To understand how the model reached its conclusions, the team analyzed how it extracted features from tumor images. “In the shallow convolution layers, the DL model extracted simple tumor edge features ... while in deeper convolution layers, it extracted complex tumor texture information ... In the last convolution layer, the DL model extracted high-level abstract features (the fourteenth layer). Although these high-level features were so intricate that they were hard to interpret by general gross observation, they were associated with LN status,” the investigators said.

The team notes that “both intratumoral and peritumoral regions were necessary for the DL model to make decisions,” which “can probably be explained by the fact that higher lymphatic vessel density in peritumoral regions might lead to higher regional LNM.”

Commenting on the study, Dr. Rees said that “the authors did a [good] job of essentially deconstructing their neural network to see what the algorithm was actually picking up on to make its decision.

“One of the nice features of deep learning is that once the algorithm has been developed and validated, the end user doesn’t need any experience in deep learning in order to use it,” he added.

Even so, “while these resources can be incredibly powerful tools, they should not function in a vacuum without human judgment,” Dr. Rees said.

The work was funded by the National Natural Science Foundation of China, among others. The investigators have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A deep learning (DL) computer model improved upon the accuracy of cervical cancer diagnoses compared to traditional radiology. This could allow some women to avoid surgery and be treated with chemotherapy instead, suggested researchers.

The model mined tumor information from pelvic sagittal contrast-enhanced T1-weighted MRIs and combined this with clinical MRI lymph node status.

It was 90.62% sensitive and 87.16% specific for predicting lymph node metastases (LNMs) in a validation cohort of women who underwent surgery for cervical cancer.

The area under the curve was 0.933. The approach was significantly associated with disease-free survival (hazard ratio, 4.59; 95% confidence interval, 2.04-10.31; P < .001).

The study was published online on July 24 in JAMA Network Open.

“The findings of this study suggest that deep learning can be used as a preoperative noninvasive tool to diagnose lymph node metastasis in cervical cancer ... This model might be used preoperatively to help gynecologists make decisions,” said investigators led by Qingxia Wu, PhD, of the Northeastern University College of Medicine and Biomedical Information Engineering in Shenyang, China.

“Studies like these suggest that deep learning has the potential to improve the way we care for our patients,” but there’s much to be done “before these types of algorithms will be commonplace,” commented Christiaan Rees, MD, PhD, an internal medicine resident at Brigham and Women’s Hospital, Boston, who has a doctorate in quantitative biomedical sciences.

Next steps include repeated validation across multiple control groups, he said in an interview, as well as “finding ways to effectively integrate these tools into the radiologist’s day-to-day practice. One possibility would be for direct integration of the algorithm into the electronic health record.”
 

Accurate prediction could lead to skipping surgery

Chemotherapy, rather than surgery, is an option for women with positive lymph nodes (LNs), so accurate prediction can help them avoid an operation and its risks, the authors said.

The problem is that “the traditional methods for assessing LN status in cervical cancer, which rely mainly on assessing the size of LNs on MRI, have limited sensitivity in diagnosing LNM in cervical cancer and might lead to inappropriate treatment decisions,” they wrote.

“Although sentinel LN dissection ... shows good sensitivity and specificity, its application is limited by available facilities and experts,” the team said.

DL is an advanced form of artificial intelligence in which a computer program continuously improves on a given task as it incorporates more data – in Dr. Wu’s study, more than 14 million images. Deep learning has recently shown promise in several imaging tasks, such as diagnosing Alzheimer’s disease and screening for breast cancer.

Once adapted for cervical cancer, DL “does not require precise tumor delineation, making it an easy-to-use method in clinical practice. In many tumor analysis tasks, DL outperforms traditional radiomic features,” the team noted.

The study involved 479 women – 338 during model development, and 141 in the validation cohorts. The mean age of the participants was 49.1 years. They had undergone radical hysterectomy with pelvic lymphadenectomy for stage IB-IIB cervical cancer within 2 weeks of a pelvic MRI. Pathology reports were used to check the accuracy of the model’s predictions.

Specificity, sensitivity, and area under the curve were a little better in the study’s development cohort than its validation group, for whom median disease-free survival was 23 months versus 31 months among the patients in the development cohort. Nodes were positive on lymphadenectomy in a little more than 20% of women in both groups.

Incorporation of both intratumoral and peritumoral regions on contrast-enhanced T1-weighted MRIs versus axial T2-weighted and axial diffusion-weighted imaging, produced the highest sensitivity. Adding MRI-LN status – defined as positive when the short-axis diameter of the largest LN on MRI was ≥1 cm – improved the model’s specificity.

To understand how the model reached its conclusions, the team analyzed how it extracted features from tumor images. “In the shallow convolution layers, the DL model extracted simple tumor edge features ... while in deeper convolution layers, it extracted complex tumor texture information ... In the last convolution layer, the DL model extracted high-level abstract features (the fourteenth layer). Although these high-level features were so intricate that they were hard to interpret by general gross observation, they were associated with LN status,” the investigators said.

The team notes that “both intratumoral and peritumoral regions were necessary for the DL model to make decisions,” which “can probably be explained by the fact that higher lymphatic vessel density in peritumoral regions might lead to higher regional LNM.”

Commenting on the study, Dr. Rees said that “the authors did a [good] job of essentially deconstructing their neural network to see what the algorithm was actually picking up on to make its decision.

“One of the nice features of deep learning is that once the algorithm has been developed and validated, the end user doesn’t need any experience in deep learning in order to use it,” he added.

Even so, “while these resources can be incredibly powerful tools, they should not function in a vacuum without human judgment,” Dr. Rees said.

The work was funded by the National Natural Science Foundation of China, among others. The investigators have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A deep learning (DL) computer model improved upon the accuracy of cervical cancer diagnoses compared to traditional radiology. This could allow some women to avoid surgery and be treated with chemotherapy instead, suggested researchers.

The model mined tumor information from pelvic sagittal contrast-enhanced T1-weighted MRIs and combined this with clinical MRI lymph node status.

It was 90.62% sensitive and 87.16% specific for predicting lymph node metastases (LNMs) in a validation cohort of women who underwent surgery for cervical cancer.

The area under the curve was 0.933. The approach was significantly associated with disease-free survival (hazard ratio, 4.59; 95% confidence interval, 2.04-10.31; P < .001).

The study was published online on July 24 in JAMA Network Open.

“The findings of this study suggest that deep learning can be used as a preoperative noninvasive tool to diagnose lymph node metastasis in cervical cancer ... This model might be used preoperatively to help gynecologists make decisions,” said investigators led by Qingxia Wu, PhD, of the Northeastern University College of Medicine and Biomedical Information Engineering in Shenyang, China.

“Studies like these suggest that deep learning has the potential to improve the way we care for our patients,” but there’s much to be done “before these types of algorithms will be commonplace,” commented Christiaan Rees, MD, PhD, an internal medicine resident at Brigham and Women’s Hospital, Boston, who has a doctorate in quantitative biomedical sciences.

Next steps include repeated validation across multiple control groups, he said in an interview, as well as “finding ways to effectively integrate these tools into the radiologist’s day-to-day practice. One possibility would be for direct integration of the algorithm into the electronic health record.”
 

Accurate prediction could lead to skipping surgery

Chemotherapy, rather than surgery, is an option for women with positive lymph nodes (LNs), so accurate prediction can help them avoid an operation and its risks, the authors said.

The problem is that “the traditional methods for assessing LN status in cervical cancer, which rely mainly on assessing the size of LNs on MRI, have limited sensitivity in diagnosing LNM in cervical cancer and might lead to inappropriate treatment decisions,” they wrote.

“Although sentinel LN dissection ... shows good sensitivity and specificity, its application is limited by available facilities and experts,” the team said.

DL is an advanced form of artificial intelligence in which a computer program continuously improves on a given task as it incorporates more data – in Dr. Wu’s study, more than 14 million images. Deep learning has recently shown promise in several imaging tasks, such as diagnosing Alzheimer’s disease and screening for breast cancer.

Once adapted for cervical cancer, DL “does not require precise tumor delineation, making it an easy-to-use method in clinical practice. In many tumor analysis tasks, DL outperforms traditional radiomic features,” the team noted.

The study involved 479 women – 338 during model development, and 141 in the validation cohorts. The mean age of the participants was 49.1 years. They had undergone radical hysterectomy with pelvic lymphadenectomy for stage IB-IIB cervical cancer within 2 weeks of a pelvic MRI. Pathology reports were used to check the accuracy of the model’s predictions.

Specificity, sensitivity, and area under the curve were a little better in the study’s development cohort than its validation group, for whom median disease-free survival was 23 months versus 31 months among the patients in the development cohort. Nodes were positive on lymphadenectomy in a little more than 20% of women in both groups.

Incorporation of both intratumoral and peritumoral regions on contrast-enhanced T1-weighted MRIs versus axial T2-weighted and axial diffusion-weighted imaging, produced the highest sensitivity. Adding MRI-LN status – defined as positive when the short-axis diameter of the largest LN on MRI was ≥1 cm – improved the model’s specificity.

To understand how the model reached its conclusions, the team analyzed how it extracted features from tumor images. “In the shallow convolution layers, the DL model extracted simple tumor edge features ... while in deeper convolution layers, it extracted complex tumor texture information ... In the last convolution layer, the DL model extracted high-level abstract features (the fourteenth layer). Although these high-level features were so intricate that they were hard to interpret by general gross observation, they were associated with LN status,” the investigators said.

The team notes that “both intratumoral and peritumoral regions were necessary for the DL model to make decisions,” which “can probably be explained by the fact that higher lymphatic vessel density in peritumoral regions might lead to higher regional LNM.”

Commenting on the study, Dr. Rees said that “the authors did a [good] job of essentially deconstructing their neural network to see what the algorithm was actually picking up on to make its decision.

“One of the nice features of deep learning is that once the algorithm has been developed and validated, the end user doesn’t need any experience in deep learning in order to use it,” he added.

Even so, “while these resources can be incredibly powerful tools, they should not function in a vacuum without human judgment,” Dr. Rees said.

The work was funded by the National Natural Science Foundation of China, among others. The investigators have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Mortality from non–small cell lung cancer (NSCLC) has fallen sharply in the United States over the past few years, and survival following its diagnosis has dramatically improved, the first analysis of its kind indicates.

“This analysis shows for the first time that nationwide mortality rates for the most common category of lung cancer, NSCLC, are declining faster than its incidence, an advance that correlates with the [FDA] approval of several targeted therapies for this cancer in recent years,” coauthor Douglas Lowy, MD, deputy director, National Cancer Institute, Bethesda, Md., said in a statement.

“Major improvements have been made in NSCLC treatment with the advent of targeted therapies and immunotherapies,” lead author Nadia Howlander, PhD, National Cancer Institute, and colleagues observed.

“The survival benefit for patients with NSCLC treated with targeted therapy has been shown in clinical trials, but our study highlights their possible effect at the population level,” they added.

In contrast, mortality from SCLC has dropped only in tandem with a decline in the incidence of SCLC, and survival has remained largely unchanged, the same analysis showed.

NSCLC is by far the most common type of lung cancer, accounting for more than 75% of all lung cancer cases in the United States. SCLC accounts for about 13%.

The study was published online Aug. 12 in the New England Journal of Medicine.

“Although overall mortality from lung cancer has been declining in the United States, little is known about mortality trends according to cancer subtype at the population level because death certificates do not record subtype information,” the authors commented.

“To address this data limitation, the U.S. Surveillance, Epidemiology and End Results (SEER) program has linked mortality records to incidence cancer cases,” the authors explained. This allowed them to calculate incidence-based mortality among men and women in the United States.

The incidence-based mortality method that the researchers used was applied to the SEER data to describe population-level mortality trends in the United States that were attributable to each subtype of lung cancer as well as gender from 2001 to 2016.

Among men, the incidence of NSCLC decreased gradually by 1.9% a year from 2001 to 2008, then more dramatically by 3.1% a year from 2008 to 2016.

Corresponding incidence-based mortality rates among men dropped by 3.2% a year from 2006 to 2013, then again more dramatically by 6.3% a year from 2013 to 2016.

“The 2-year relative survival among patients with lung cancer improved substantially from 26% among men with NSCLC diagnosed in 2001 to 35% among those with NSCLC diagnosed in 2014,” the researchers added.

Among women, the incidence of NSCLC remained unchanged between 2001 and 2006, after which it began to drop by 1.5% a year from 2006 to 2016.

“In contrast, incidence-based mortality decreased slowly [among women] by 2.3% annually ... from 2006 through 2014 and then at a faster rate of 5.9% annually ... from 2014 through 2016,” the authors noted.

The 2-year relative survival rate for patients with NSCLC was higher among women than among men, improving from 35% in 2001 to 44% in 2014.

Improvements in survival were also observed for all races and ethnicities, despite concerns that new cancer treatments might increase treatment disparities between races, because they are all so expensive, the authors commented.

Mortality from SCLC declined by 4.3% a year among men, but that decline was entirely due to a similar decrease in the incidence of SCLC. Survival at 2 years for patients with this subtype of lung cancer remained largely unchanged over the same interval.

Genetic testing

The accelerating decline in NSCLC mortality starting in 2013 corresponds to the period in which clinicians began to routinely test for molecular alterations in epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK), the authors pointed out.

In 2012, the National Comprehensive Cancer Network recommended that all patients with nonsquamous NSCLC undergo genetic testing for EGFR mutations and ALK rearrangements.

At about the same time, the FDA approved a number of targeted therapies for tumors that are sensitive to targeted tyrosine kinase inhibition.

More recently, immunotherapies that act as programmed cell death inhibitors have substantially improved NSCLC outcomes, the authors noted.

The first of these was approved for NSCLC in 2015 (pembrolizumab). It was followed by a number of similar agents. It is unlikely that their approval contributed to the observed decline in NSCLC mortality, which started to accelerate in 2013 in the United States, the authors commented.

Nevertheless, the effect that the immune checkpoint inhibitors has had on the survival of patients with NSCLC can be expected to continue and to extend improvement in survival beyond the current study endpoint in 2016, they suggest.

Another contributing factor is the decline in smoking that has occurred in the United States since the 1960s. This has led to the decrease in the incidence of lung cancer. The faster decrease in the incidence of SCLC, compared with NSCLC can be explained by the higher relative risk of smoking with regard to SCLC compared to NSCLC, they commented.

Similarly, the faster decrease in lung cancer incidence in men compared to women can be explained by the relative difference in the prevalence of smoking between men and women, they added.

The authors disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Mortality from non–small cell lung cancer (NSCLC) has fallen sharply in the United States over the past few years, and survival following its diagnosis has dramatically improved, the first analysis of its kind indicates.

“This analysis shows for the first time that nationwide mortality rates for the most common category of lung cancer, NSCLC, are declining faster than its incidence, an advance that correlates with the [FDA] approval of several targeted therapies for this cancer in recent years,” coauthor Douglas Lowy, MD, deputy director, National Cancer Institute, Bethesda, Md., said in a statement.

“Major improvements have been made in NSCLC treatment with the advent of targeted therapies and immunotherapies,” lead author Nadia Howlander, PhD, National Cancer Institute, and colleagues observed.

“The survival benefit for patients with NSCLC treated with targeted therapy has been shown in clinical trials, but our study highlights their possible effect at the population level,” they added.

In contrast, mortality from SCLC has dropped only in tandem with a decline in the incidence of SCLC, and survival has remained largely unchanged, the same analysis showed.

NSCLC is by far the most common type of lung cancer, accounting for more than 75% of all lung cancer cases in the United States. SCLC accounts for about 13%.

The study was published online Aug. 12 in the New England Journal of Medicine.

“Although overall mortality from lung cancer has been declining in the United States, little is known about mortality trends according to cancer subtype at the population level because death certificates do not record subtype information,” the authors commented.

“To address this data limitation, the U.S. Surveillance, Epidemiology and End Results (SEER) program has linked mortality records to incidence cancer cases,” the authors explained. This allowed them to calculate incidence-based mortality among men and women in the United States.

The incidence-based mortality method that the researchers used was applied to the SEER data to describe population-level mortality trends in the United States that were attributable to each subtype of lung cancer as well as gender from 2001 to 2016.

Among men, the incidence of NSCLC decreased gradually by 1.9% a year from 2001 to 2008, then more dramatically by 3.1% a year from 2008 to 2016.

Corresponding incidence-based mortality rates among men dropped by 3.2% a year from 2006 to 2013, then again more dramatically by 6.3% a year from 2013 to 2016.

“The 2-year relative survival among patients with lung cancer improved substantially from 26% among men with NSCLC diagnosed in 2001 to 35% among those with NSCLC diagnosed in 2014,” the researchers added.

Among women, the incidence of NSCLC remained unchanged between 2001 and 2006, after which it began to drop by 1.5% a year from 2006 to 2016.

“In contrast, incidence-based mortality decreased slowly [among women] by 2.3% annually ... from 2006 through 2014 and then at a faster rate of 5.9% annually ... from 2014 through 2016,” the authors noted.

The 2-year relative survival rate for patients with NSCLC was higher among women than among men, improving from 35% in 2001 to 44% in 2014.

Improvements in survival were also observed for all races and ethnicities, despite concerns that new cancer treatments might increase treatment disparities between races, because they are all so expensive, the authors commented.

Mortality from SCLC declined by 4.3% a year among men, but that decline was entirely due to a similar decrease in the incidence of SCLC. Survival at 2 years for patients with this subtype of lung cancer remained largely unchanged over the same interval.

Genetic testing

The accelerating decline in NSCLC mortality starting in 2013 corresponds to the period in which clinicians began to routinely test for molecular alterations in epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK), the authors pointed out.

In 2012, the National Comprehensive Cancer Network recommended that all patients with nonsquamous NSCLC undergo genetic testing for EGFR mutations and ALK rearrangements.

At about the same time, the FDA approved a number of targeted therapies for tumors that are sensitive to targeted tyrosine kinase inhibition.

More recently, immunotherapies that act as programmed cell death inhibitors have substantially improved NSCLC outcomes, the authors noted.

The first of these was approved for NSCLC in 2015 (pembrolizumab). It was followed by a number of similar agents. It is unlikely that their approval contributed to the observed decline in NSCLC mortality, which started to accelerate in 2013 in the United States, the authors commented.

Nevertheless, the effect that the immune checkpoint inhibitors has had on the survival of patients with NSCLC can be expected to continue and to extend improvement in survival beyond the current study endpoint in 2016, they suggest.

Another contributing factor is the decline in smoking that has occurred in the United States since the 1960s. This has led to the decrease in the incidence of lung cancer. The faster decrease in the incidence of SCLC, compared with NSCLC can be explained by the higher relative risk of smoking with regard to SCLC compared to NSCLC, they commented.

Similarly, the faster decrease in lung cancer incidence in men compared to women can be explained by the relative difference in the prevalence of smoking between men and women, they added.

The authors disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Mortality from non–small cell lung cancer (NSCLC) has fallen sharply in the United States over the past few years, and survival following its diagnosis has dramatically improved, the first analysis of its kind indicates.

“This analysis shows for the first time that nationwide mortality rates for the most common category of lung cancer, NSCLC, are declining faster than its incidence, an advance that correlates with the [FDA] approval of several targeted therapies for this cancer in recent years,” coauthor Douglas Lowy, MD, deputy director, National Cancer Institute, Bethesda, Md., said in a statement.

“Major improvements have been made in NSCLC treatment with the advent of targeted therapies and immunotherapies,” lead author Nadia Howlander, PhD, National Cancer Institute, and colleagues observed.

“The survival benefit for patients with NSCLC treated with targeted therapy has been shown in clinical trials, but our study highlights their possible effect at the population level,” they added.

In contrast, mortality from SCLC has dropped only in tandem with a decline in the incidence of SCLC, and survival has remained largely unchanged, the same analysis showed.

NSCLC is by far the most common type of lung cancer, accounting for more than 75% of all lung cancer cases in the United States. SCLC accounts for about 13%.

The study was published online Aug. 12 in the New England Journal of Medicine.

“Although overall mortality from lung cancer has been declining in the United States, little is known about mortality trends according to cancer subtype at the population level because death certificates do not record subtype information,” the authors commented.

“To address this data limitation, the U.S. Surveillance, Epidemiology and End Results (SEER) program has linked mortality records to incidence cancer cases,” the authors explained. This allowed them to calculate incidence-based mortality among men and women in the United States.

The incidence-based mortality method that the researchers used was applied to the SEER data to describe population-level mortality trends in the United States that were attributable to each subtype of lung cancer as well as gender from 2001 to 2016.

Among men, the incidence of NSCLC decreased gradually by 1.9% a year from 2001 to 2008, then more dramatically by 3.1% a year from 2008 to 2016.

Corresponding incidence-based mortality rates among men dropped by 3.2% a year from 2006 to 2013, then again more dramatically by 6.3% a year from 2013 to 2016.

“The 2-year relative survival among patients with lung cancer improved substantially from 26% among men with NSCLC diagnosed in 2001 to 35% among those with NSCLC diagnosed in 2014,” the researchers added.

Among women, the incidence of NSCLC remained unchanged between 2001 and 2006, after which it began to drop by 1.5% a year from 2006 to 2016.

“In contrast, incidence-based mortality decreased slowly [among women] by 2.3% annually ... from 2006 through 2014 and then at a faster rate of 5.9% annually ... from 2014 through 2016,” the authors noted.

The 2-year relative survival rate for patients with NSCLC was higher among women than among men, improving from 35% in 2001 to 44% in 2014.

Improvements in survival were also observed for all races and ethnicities, despite concerns that new cancer treatments might increase treatment disparities between races, because they are all so expensive, the authors commented.

Mortality from SCLC declined by 4.3% a year among men, but that decline was entirely due to a similar decrease in the incidence of SCLC. Survival at 2 years for patients with this subtype of lung cancer remained largely unchanged over the same interval.

Genetic testing

The accelerating decline in NSCLC mortality starting in 2013 corresponds to the period in which clinicians began to routinely test for molecular alterations in epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK), the authors pointed out.

In 2012, the National Comprehensive Cancer Network recommended that all patients with nonsquamous NSCLC undergo genetic testing for EGFR mutations and ALK rearrangements.

At about the same time, the FDA approved a number of targeted therapies for tumors that are sensitive to targeted tyrosine kinase inhibition.

More recently, immunotherapies that act as programmed cell death inhibitors have substantially improved NSCLC outcomes, the authors noted.

The first of these was approved for NSCLC in 2015 (pembrolizumab). It was followed by a number of similar agents. It is unlikely that their approval contributed to the observed decline in NSCLC mortality, which started to accelerate in 2013 in the United States, the authors commented.

Nevertheless, the effect that the immune checkpoint inhibitors has had on the survival of patients with NSCLC can be expected to continue and to extend improvement in survival beyond the current study endpoint in 2016, they suggest.

Another contributing factor is the decline in smoking that has occurred in the United States since the 1960s. This has led to the decrease in the incidence of lung cancer. The faster decrease in the incidence of SCLC, compared with NSCLC can be explained by the higher relative risk of smoking with regard to SCLC compared to NSCLC, they commented.

Similarly, the faster decrease in lung cancer incidence in men compared to women can be explained by the relative difference in the prevalence of smoking between men and women, they added.

The authors disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

If people try telemedicine, they’ll like telemedicine. And if they want to avoid a doctor’s office, as most people do these days, they’ll try telemedicine. That is the message coming from 1,000 people surveyed for DocASAP, a provider of online patient access and engagement systems.

Here are a couple of numbers: 92% of those who made a telemedicine visit said they were satisfied with the overall appointment experience, and 91% said that they are more likely to schedule a telemedicine visit instead of an in-person appointment. All of the survey respondents had visited a health care provider in the past year, and 40% already had made a telemedicine visit, DocASAP reported.

“Telehealth has quickly emerged as the preferred care setting during the pandemic and will drive patient behavior in the future,” Puneet Maheshwari, DocASAP cofounder and CEO, said in a statement. “As providers continue to adopt innovative technology to power a more seamless, end-to-end digital consumer experience, I expect telehealth to become fully integrated into overall care management.”

For now, though, COVID-19 is an overriding concern and health care facilities are suspect. When respondents were asked to identify the types of public facilities where they felt safe, hospitals were named by 32%, doctors’ offices by 26%, and ED/urgent care by just 12%, the DocASAP report said. Even public transportation got 13%.

The safest place to be, according to 42% of the respondents? The grocery store.

Of those surveyed, 43% “indicated they will not feel safe entering any health care setting until at least the fall,” the company said. An even higher share of patients, 68%, canceled or postponed an in-person appointment during the pandemic.

“No longer are remote health services viewed as ‘nice to have’ – they are now a must-have care delivery option,” DocASAP said in their report.

Safety concerns involving COVID-19, named by 47% of the sample, were the leading factor that would influence patients’ decision to schedule a telemedicine visit. Insurance coverage was next at 43%, followed by “ease of accessing quality care” at 40%, the report said.

Among those who had made a telemedicine visit, scheduling the appointment was the most satisfying aspect of the experience, according to 54% of respondents, with day-of-appointment wait time next at 38% and quality of the video/audio technology tied with preappointment communication at almost 33%, the survey data show.

Conversely, scheduling the appointment also was declared the most frustrating aspect of the telemedicine experience, although the total in that category was a much lower 29%.

“The pandemic has thrust profound change on every aspect of life, particularly health care. … Innovations – like digital and telehealth solutions – designed to meet patient needs will likely become embedded into the health care delivery system,” DocASAP said.

The survey was commissioned by DocASAP and conducted by marketing research company OnePoll on June 29-30, 2020.
 

[email protected]

If people try telemedicine, they’ll like telemedicine. And if they want to avoid a doctor’s office, as most people do these days, they’ll try telemedicine. That is the message coming from 1,000 people surveyed for DocASAP, a provider of online patient access and engagement systems.

Here are a couple of numbers: 92% of those who made a telemedicine visit said they were satisfied with the overall appointment experience, and 91% said that they are more likely to schedule a telemedicine visit instead of an in-person appointment. All of the survey respondents had visited a health care provider in the past year, and 40% already had made a telemedicine visit, DocASAP reported.

“Telehealth has quickly emerged as the preferred care setting during the pandemic and will drive patient behavior in the future,” Puneet Maheshwari, DocASAP cofounder and CEO, said in a statement. “As providers continue to adopt innovative technology to power a more seamless, end-to-end digital consumer experience, I expect telehealth to become fully integrated into overall care management.”

For now, though, COVID-19 is an overriding concern and health care facilities are suspect. When respondents were asked to identify the types of public facilities where they felt safe, hospitals were named by 32%, doctors’ offices by 26%, and ED/urgent care by just 12%, the DocASAP report said. Even public transportation got 13%.

The safest place to be, according to 42% of the respondents? The grocery store.

Of those surveyed, 43% “indicated they will not feel safe entering any health care setting until at least the fall,” the company said. An even higher share of patients, 68%, canceled or postponed an in-person appointment during the pandemic.

“No longer are remote health services viewed as ‘nice to have’ – they are now a must-have care delivery option,” DocASAP said in their report.

Safety concerns involving COVID-19, named by 47% of the sample, were the leading factor that would influence patients’ decision to schedule a telemedicine visit. Insurance coverage was next at 43%, followed by “ease of accessing quality care” at 40%, the report said.

Among those who had made a telemedicine visit, scheduling the appointment was the most satisfying aspect of the experience, according to 54% of respondents, with day-of-appointment wait time next at 38% and quality of the video/audio technology tied with preappointment communication at almost 33%, the survey data show.

Conversely, scheduling the appointment also was declared the most frustrating aspect of the telemedicine experience, although the total in that category was a much lower 29%.

“The pandemic has thrust profound change on every aspect of life, particularly health care. … Innovations – like digital and telehealth solutions – designed to meet patient needs will likely become embedded into the health care delivery system,” DocASAP said.

The survey was commissioned by DocASAP and conducted by marketing research company OnePoll on June 29-30, 2020.
 

[email protected]

If people try telemedicine, they’ll like telemedicine. And if they want to avoid a doctor’s office, as most people do these days, they’ll try telemedicine. That is the message coming from 1,000 people surveyed for DocASAP, a provider of online patient access and engagement systems.

Here are a couple of numbers: 92% of those who made a telemedicine visit said they were satisfied with the overall appointment experience, and 91% said that they are more likely to schedule a telemedicine visit instead of an in-person appointment. All of the survey respondents had visited a health care provider in the past year, and 40% already had made a telemedicine visit, DocASAP reported.

“Telehealth has quickly emerged as the preferred care setting during the pandemic and will drive patient behavior in the future,” Puneet Maheshwari, DocASAP cofounder and CEO, said in a statement. “As providers continue to adopt innovative technology to power a more seamless, end-to-end digital consumer experience, I expect telehealth to become fully integrated into overall care management.”

For now, though, COVID-19 is an overriding concern and health care facilities are suspect. When respondents were asked to identify the types of public facilities where they felt safe, hospitals were named by 32%, doctors’ offices by 26%, and ED/urgent care by just 12%, the DocASAP report said. Even public transportation got 13%.

The safest place to be, according to 42% of the respondents? The grocery store.

Of those surveyed, 43% “indicated they will not feel safe entering any health care setting until at least the fall,” the company said. An even higher share of patients, 68%, canceled or postponed an in-person appointment during the pandemic.

“No longer are remote health services viewed as ‘nice to have’ – they are now a must-have care delivery option,” DocASAP said in their report.

Safety concerns involving COVID-19, named by 47% of the sample, were the leading factor that would influence patients’ decision to schedule a telemedicine visit. Insurance coverage was next at 43%, followed by “ease of accessing quality care” at 40%, the report said.

Among those who had made a telemedicine visit, scheduling the appointment was the most satisfying aspect of the experience, according to 54% of respondents, with day-of-appointment wait time next at 38% and quality of the video/audio technology tied with preappointment communication at almost 33%, the survey data show.

Conversely, scheduling the appointment also was declared the most frustrating aspect of the telemedicine experience, although the total in that category was a much lower 29%.

“The pandemic has thrust profound change on every aspect of life, particularly health care. … Innovations – like digital and telehealth solutions – designed to meet patient needs will likely become embedded into the health care delivery system,” DocASAP said.

The survey was commissioned by DocASAP and conducted by marketing research company OnePoll on June 29-30, 2020.
 

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To retain the label of “gluten free,” manufacturers of foods that are fermented and hydrolyzed, or that contain fermented or hydrolyzed ingredients, must make and keep detailed records of the manufacturing and production process, according to a final rule issued by the Food and Drug Administration.

In an announcement released on Aug. 12, the FDA stated that manufacturers must confirm that food products such as soy sauce, yogurt, sauerkraut, pickles, cheese, and green olives, as well as distilled foods such as vinegar, meet the definition of gluten free before the fermentation or hydrolysis process. In addition, the rule states that “the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process,” according to the FDA.

Gluten breaks down during fermentation and hydrolysis, and the gluten-free status of products manufactured in this way can’t be confirmed after the process using currently available methods, according to the FDA.

The new rule is designed to ensure that products labeled as gluten-free meet the definition of gluten free, which remains unchanged from the FDA guidance in 2013.

“The FDA continues to work to protect people with celiac disease, which impacts at least 3 million Americans,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

“The agency has taken a number of steps on this front by first establishing a standardized definition of gluten free, and now by continuing to work to ensure manufacturers are keeping the products that are labeled with this claim gluten free,” he emphasized.

The final rule states that manufacturers will not need to keep such records if and when other analytical methods are developed, but in the meantime products that do not meet the definition will be deemed misbranded, according to the FDA.

To retain the label of “gluten free,” manufacturers of foods that are fermented and hydrolyzed, or that contain fermented or hydrolyzed ingredients, must make and keep detailed records of the manufacturing and production process, according to a final rule issued by the Food and Drug Administration.

In an announcement released on Aug. 12, the FDA stated that manufacturers must confirm that food products such as soy sauce, yogurt, sauerkraut, pickles, cheese, and green olives, as well as distilled foods such as vinegar, meet the definition of gluten free before the fermentation or hydrolysis process. In addition, the rule states that “the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process,” according to the FDA.

Gluten breaks down during fermentation and hydrolysis, and the gluten-free status of products manufactured in this way can’t be confirmed after the process using currently available methods, according to the FDA.

The new rule is designed to ensure that products labeled as gluten-free meet the definition of gluten free, which remains unchanged from the FDA guidance in 2013.

“The FDA continues to work to protect people with celiac disease, which impacts at least 3 million Americans,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

“The agency has taken a number of steps on this front by first establishing a standardized definition of gluten free, and now by continuing to work to ensure manufacturers are keeping the products that are labeled with this claim gluten free,” he emphasized.

The final rule states that manufacturers will not need to keep such records if and when other analytical methods are developed, but in the meantime products that do not meet the definition will be deemed misbranded, according to the FDA.

To retain the label of “gluten free,” manufacturers of foods that are fermented and hydrolyzed, or that contain fermented or hydrolyzed ingredients, must make and keep detailed records of the manufacturing and production process, according to a final rule issued by the Food and Drug Administration.

In an announcement released on Aug. 12, the FDA stated that manufacturers must confirm that food products such as soy sauce, yogurt, sauerkraut, pickles, cheese, and green olives, as well as distilled foods such as vinegar, meet the definition of gluten free before the fermentation or hydrolysis process. In addition, the rule states that “the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process,” according to the FDA.

Gluten breaks down during fermentation and hydrolysis, and the gluten-free status of products manufactured in this way can’t be confirmed after the process using currently available methods, according to the FDA.

The new rule is designed to ensure that products labeled as gluten-free meet the definition of gluten free, which remains unchanged from the FDA guidance in 2013.

“The FDA continues to work to protect people with celiac disease, which impacts at least 3 million Americans,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

“The agency has taken a number of steps on this front by first establishing a standardized definition of gluten free, and now by continuing to work to ensure manufacturers are keeping the products that are labeled with this claim gluten free,” he emphasized.

The final rule states that manufacturers will not need to keep such records if and when other analytical methods are developed, but in the meantime products that do not meet the definition will be deemed misbranded, according to the FDA.

Advances in cancer treatment have brought a range of potential issues hospitalists are likely to see in admitted patients – many of which can escalate quickly into life-threatening emergencies if they’re not handled properly, an oncologist said in a presentation at HM20 Virtual, hosted by the Society of Hospital Medicine.

Checkpoint inhibitors and CAR T-cell therapy – revolutions in fighting cancer but potential instigators of serious side effects because of the way they set the immune system in motion – can have consequences throughout the body, said Megan Kruse, MD, an oncologist at the Cleveland Clinic.

Checkpoint inhibitors, which cause the body to essentially take its foot off the break of the immune system, in particular have diverse effects, Dr. Kruse said.

“Suffice it to say that any odd symptom in any organ system in a patient on immunotherapy, or with a history of immunotherapy, can be cause for concern,” she said. Most common are skin, gut, endocrine, lung, and musculoskeletal involvement. Cardiovascular, hematologic, renal, neurologic, and ophthalmological effects are less common, but when they happen, they’re often dramatic and need urgent management.

With these medications –which include anti–programmed death-1 agents pembrolizumab and nivolumab and anti–PD-ligand 1 agents atezolizumab and avelumab, among others – rash is often seen first, followed by diarrhea and colitis. Hypophysitis, which requires intervention, and liver toxicity, which usually tapers off on its own, often occur about 6-8 weeks into treatment. There are no rigid rules for the arrival of these symptoms, however, Dr. Kruse said.

“We must have a high index of suspicion. ... They really can occur at any point after a patient has had even one dose of an immunologic agent,” she said.

In more serious cases, steroids are typically the go-to treatment, she added, because they will quickly tamp down the immune activation brought on by the medications.

“When these drugs first came out, we were all very concerned about adding steroids,” she said. “In follow-up studies, it actually looks like we don’t attenuate the anticancer response very much by instituting steroids when clinically appropriate. And so you all should feel very comfortable adding steroids while waiting to talk to oncology.”

In these cases, the steroid taper is done very slowly, over weeks or even months.

With CAR T-cell therapy – in which patients receive T cells to target liquid tumors – cytokine release syndrome (CRS) can occur, often within 14 days after treatment. Dr. Kruse cautioned that it can present with symptoms similar to tumor lysis syndrome or sepsis.

“Patients are at a high risk of bacterial infection, so antibiotics are advised,” she said.

In these cases, fever is often a harbinger, often arriving at least a day before the rest of the symptoms of CRS.

Early treatment with the interleukin-6 inhibitor tocilizumab is recommended for these patients, she said. This agent has been shown to have a 69% response rate in severe CRS and has no known effect on the efficacy of the CAR T-cell treatment.

Dr. Kruse also touched on several other conditions that can rise to the level of emergencies in cancer treatment:

• In cases of neutropenic fever, patients should be treated as soon as possible with antibiotics, and some solid-tumor patients at lower risk can be treated as outpatients, she said. Those with hematologic cancer, however, will need inpatient care.
• For tumor lysis syndrome with renal failure, fluids should be started quickly. Rasburicase, a recombinant urate oxidase enzyme, can be considered in some cases, but requires caution.
• In cases of spinal cord compression, a full spine MRI should be completed because about a third of patients have multilevel involvement. Steroids should be started as soon as possible.

In a question-and-answer session, much of the discussion focused on when outpatient care for neutropenic fever was possible. Dr. Kruse said those who need to be admitted for neutropenic fever treatment tend to be those with hematologic malignancies because their treatment is so myelosuppressive.

“Their window of complications is longer,” she said. Solid tumor patients, on the other hand, will usually improve “fairly rapidly” in about 3-4 days.

Many session viewers expressed surprise at the possibility of outpatient neutropenic fever treatment. Dr. Kruse said that the Cleveland Clinic’s incorporation of this approach has included the input of neutropenic fever risk index scoring into their electronic medical record and a good deal of in-service training.

Asked about appropriate swabbing of patients for COVID-19 before chemotherapy, Dr. Kruse said that her center screens only patients who need to be hospitalized for the treatment – those with a high incidence of prolonged neutropenia.

“For our typical outpatients who are receiving chemotherapy,” she said, “we are not swabbing them.” But they have intense fever screening and distance measures in place.

Dr. Kruse reported advisory board involvement for Novartis Oncology and consulting for Puma Biotechnology.

Advances in cancer treatment have brought a range of potential issues hospitalists are likely to see in admitted patients – many of which can escalate quickly into life-threatening emergencies if they’re not handled properly, an oncologist said in a presentation at HM20 Virtual, hosted by the Society of Hospital Medicine.

Checkpoint inhibitors and CAR T-cell therapy – revolutions in fighting cancer but potential instigators of serious side effects because of the way they set the immune system in motion – can have consequences throughout the body, said Megan Kruse, MD, an oncologist at the Cleveland Clinic.

Checkpoint inhibitors, which cause the body to essentially take its foot off the break of the immune system, in particular have diverse effects, Dr. Kruse said.

“Suffice it to say that any odd symptom in any organ system in a patient on immunotherapy, or with a history of immunotherapy, can be cause for concern,” she said. Most common are skin, gut, endocrine, lung, and musculoskeletal involvement. Cardiovascular, hematologic, renal, neurologic, and ophthalmological effects are less common, but when they happen, they’re often dramatic and need urgent management.

With these medications –which include anti–programmed death-1 agents pembrolizumab and nivolumab and anti–PD-ligand 1 agents atezolizumab and avelumab, among others – rash is often seen first, followed by diarrhea and colitis. Hypophysitis, which requires intervention, and liver toxicity, which usually tapers off on its own, often occur about 6-8 weeks into treatment. There are no rigid rules for the arrival of these symptoms, however, Dr. Kruse said.

“We must have a high index of suspicion. ... They really can occur at any point after a patient has had even one dose of an immunologic agent,” she said.

In more serious cases, steroids are typically the go-to treatment, she added, because they will quickly tamp down the immune activation brought on by the medications.

“When these drugs first came out, we were all very concerned about adding steroids,” she said. “In follow-up studies, it actually looks like we don’t attenuate the anticancer response very much by instituting steroids when clinically appropriate. And so you all should feel very comfortable adding steroids while waiting to talk to oncology.”

In these cases, the steroid taper is done very slowly, over weeks or even months.

With CAR T-cell therapy – in which patients receive T cells to target liquid tumors – cytokine release syndrome (CRS) can occur, often within 14 days after treatment. Dr. Kruse cautioned that it can present with symptoms similar to tumor lysis syndrome or sepsis.

“Patients are at a high risk of bacterial infection, so antibiotics are advised,” she said.

In these cases, fever is often a harbinger, often arriving at least a day before the rest of the symptoms of CRS.

Early treatment with the interleukin-6 inhibitor tocilizumab is recommended for these patients, she said. This agent has been shown to have a 69% response rate in severe CRS and has no known effect on the efficacy of the CAR T-cell treatment.

Dr. Kruse also touched on several other conditions that can rise to the level of emergencies in cancer treatment:

• In cases of neutropenic fever, patients should be treated as soon as possible with antibiotics, and some solid-tumor patients at lower risk can be treated as outpatients, she said. Those with hematologic cancer, however, will need inpatient care.
• For tumor lysis syndrome with renal failure, fluids should be started quickly. Rasburicase, a recombinant urate oxidase enzyme, can be considered in some cases, but requires caution.
• In cases of spinal cord compression, a full spine MRI should be completed because about a third of patients have multilevel involvement. Steroids should be started as soon as possible.

In a question-and-answer session, much of the discussion focused on when outpatient care for neutropenic fever was possible. Dr. Kruse said those who need to be admitted for neutropenic fever treatment tend to be those with hematologic malignancies because their treatment is so myelosuppressive.

“Their window of complications is longer,” she said. Solid tumor patients, on the other hand, will usually improve “fairly rapidly” in about 3-4 days.

Many session viewers expressed surprise at the possibility of outpatient neutropenic fever treatment. Dr. Kruse said that the Cleveland Clinic’s incorporation of this approach has included the input of neutropenic fever risk index scoring into their electronic medical record and a good deal of in-service training.

Asked about appropriate swabbing of patients for COVID-19 before chemotherapy, Dr. Kruse said that her center screens only patients who need to be hospitalized for the treatment – those with a high incidence of prolonged neutropenia.

“For our typical outpatients who are receiving chemotherapy,” she said, “we are not swabbing them.” But they have intense fever screening and distance measures in place.

Dr. Kruse reported advisory board involvement for Novartis Oncology and consulting for Puma Biotechnology.

Advances in cancer treatment have brought a range of potential issues hospitalists are likely to see in admitted patients – many of which can escalate quickly into life-threatening emergencies if they’re not handled properly, an oncologist said in a presentation at HM20 Virtual, hosted by the Society of Hospital Medicine.

Checkpoint inhibitors and CAR T-cell therapy – revolutions in fighting cancer but potential instigators of serious side effects because of the way they set the immune system in motion – can have consequences throughout the body, said Megan Kruse, MD, an oncologist at the Cleveland Clinic.

Checkpoint inhibitors, which cause the body to essentially take its foot off the break of the immune system, in particular have diverse effects, Dr. Kruse said.

“Suffice it to say that any odd symptom in any organ system in a patient on immunotherapy, or with a history of immunotherapy, can be cause for concern,” she said. Most common are skin, gut, endocrine, lung, and musculoskeletal involvement. Cardiovascular, hematologic, renal, neurologic, and ophthalmological effects are less common, but when they happen, they’re often dramatic and need urgent management.

With these medications –which include anti–programmed death-1 agents pembrolizumab and nivolumab and anti–PD-ligand 1 agents atezolizumab and avelumab, among others – rash is often seen first, followed by diarrhea and colitis. Hypophysitis, which requires intervention, and liver toxicity, which usually tapers off on its own, often occur about 6-8 weeks into treatment. There are no rigid rules for the arrival of these symptoms, however, Dr. Kruse said.

“We must have a high index of suspicion. ... They really can occur at any point after a patient has had even one dose of an immunologic agent,” she said.

In more serious cases, steroids are typically the go-to treatment, she added, because they will quickly tamp down the immune activation brought on by the medications.

“When these drugs first came out, we were all very concerned about adding steroids,” she said. “In follow-up studies, it actually looks like we don’t attenuate the anticancer response very much by instituting steroids when clinically appropriate. And so you all should feel very comfortable adding steroids while waiting to talk to oncology.”

In these cases, the steroid taper is done very slowly, over weeks or even months.

With CAR T-cell therapy – in which patients receive T cells to target liquid tumors – cytokine release syndrome (CRS) can occur, often within 14 days after treatment. Dr. Kruse cautioned that it can present with symptoms similar to tumor lysis syndrome or sepsis.

“Patients are at a high risk of bacterial infection, so antibiotics are advised,” she said.

In these cases, fever is often a harbinger, often arriving at least a day before the rest of the symptoms of CRS.

Early treatment with the interleukin-6 inhibitor tocilizumab is recommended for these patients, she said. This agent has been shown to have a 69% response rate in severe CRS and has no known effect on the efficacy of the CAR T-cell treatment.

Dr. Kruse also touched on several other conditions that can rise to the level of emergencies in cancer treatment:

• In cases of neutropenic fever, patients should be treated as soon as possible with antibiotics, and some solid-tumor patients at lower risk can be treated as outpatients, she said. Those with hematologic cancer, however, will need inpatient care.
• For tumor lysis syndrome with renal failure, fluids should be started quickly. Rasburicase, a recombinant urate oxidase enzyme, can be considered in some cases, but requires caution.
• In cases of spinal cord compression, a full spine MRI should be completed because about a third of patients have multilevel involvement. Steroids should be started as soon as possible.

In a question-and-answer session, much of the discussion focused on when outpatient care for neutropenic fever was possible. Dr. Kruse said those who need to be admitted for neutropenic fever treatment tend to be those with hematologic malignancies because their treatment is so myelosuppressive.

“Their window of complications is longer,” she said. Solid tumor patients, on the other hand, will usually improve “fairly rapidly” in about 3-4 days.

Many session viewers expressed surprise at the possibility of outpatient neutropenic fever treatment. Dr. Kruse said that the Cleveland Clinic’s incorporation of this approach has included the input of neutropenic fever risk index scoring into their electronic medical record and a good deal of in-service training.

Asked about appropriate swabbing of patients for COVID-19 before chemotherapy, Dr. Kruse said that her center screens only patients who need to be hospitalized for the treatment – those with a high incidence of prolonged neutropenia.

“For our typical outpatients who are receiving chemotherapy,” she said, “we are not swabbing them.” But they have intense fever screening and distance measures in place.

Dr. Kruse reported advisory board involvement for Novartis Oncology and consulting for Puma Biotechnology.

The Society of Hospital Medicine prides itself on bringing a broad range of experts together with the largest gathering of hospitalists at any conference – virtual or otherwise! Hospitalists, nurse practitioners, physician assistants, executives, pharmacists, educators, and practitioners of many hospital-based specialties make HM20 Virtual a unique educational experience.

We know that patients depend on you to have pertinent, updated, and timely information for their acute care needs. HM20 Virtual can provide the information you need to stay abreast in this complex and ever-changing year. From COVID-19 to common diagnosis, from racism/bias to blood glucose, from peds to pulmonary embolism, HM20 Virtual covers important topics for all acute care and hospital clinicians and professionals.

This year’s conference is something new. To meet the ever-changing challenges that the year 2020 has brought all of us, HM20 Virtual has addressed one of the limitations of an online conference: personal interactions. With Simulive sessions, you will have the opportunity to chat with fellow participants and interact with the expert faculty in real time! Of course, all Simulive sessions will be available on demand after the fact for those of you who need alternate times to watch.

Be sure to attend some (or all!) of this week’s Simulive sessions. There is something for everyone:

• On Tuesday, Aug. 18, Sam Brondfield, MD, will discuss oncologic work-ups, and James Kim, MD, will make antibiotics simple (where was Dr. Kim for my medical school training?).
• Wednesday, Aug. 19, circles back to another epidemic, the opioid crisis, presented by Theresa Vettese, MD. Dr. Alfred Burger updates us on Clinical Practice Guidelines, and Jeff Trost, MD, brings us up to speed on the effects of COVID-19 and the heart.
• Thursday, Aug. 20, wraps up week 2 of HM20 Virtual with Population Health by Adam Myers, MD, and Updates in Pneumonia by Joanna Bonsall, MD.

The personal interactions don’t have to stop there! HM20 Virtual also features Special Interest Forums. Check out the list and find out how to join by visiting the HM20 Virtual website.

We look forward to “seeing” you at HM20 Virtual. We always want your feedback; however, in this socially distanced, travel-limited world, your input is more important now than ever. Be sure to let us know how this new format works for your learning, networking, and professional needs.

On behalf of the SHM board of directors, the SHM staff, and myself, we hope you enjoy HM20 Virtual. Through this meeting’s rich selection of educational opportunities – and the innovative approaches in a world dominated by the coronavirus – SHM continues to further its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, empowering hospitalists and transforming patient care.

Dr. Howell is CEO of the Society of Hospital Medicine.

The Society of Hospital Medicine prides itself on bringing a broad range of experts together with the largest gathering of hospitalists at any conference – virtual or otherwise! Hospitalists, nurse practitioners, physician assistants, executives, pharmacists, educators, and practitioners of many hospital-based specialties make HM20 Virtual a unique educational experience.

We know that patients depend on you to have pertinent, updated, and timely information for their acute care needs. HM20 Virtual can provide the information you need to stay abreast in this complex and ever-changing year. From COVID-19 to common diagnosis, from racism/bias to blood glucose, from peds to pulmonary embolism, HM20 Virtual covers important topics for all acute care and hospital clinicians and professionals.

This year’s conference is something new. To meet the ever-changing challenges that the year 2020 has brought all of us, HM20 Virtual has addressed one of the limitations of an online conference: personal interactions. With Simulive sessions, you will have the opportunity to chat with fellow participants and interact with the expert faculty in real time! Of course, all Simulive sessions will be available on demand after the fact for those of you who need alternate times to watch.

Be sure to attend some (or all!) of this week’s Simulive sessions. There is something for everyone:

• On Tuesday, Aug. 18, Sam Brondfield, MD, will discuss oncologic work-ups, and James Kim, MD, will make antibiotics simple (where was Dr. Kim for my medical school training?).
• Wednesday, Aug. 19, circles back to another epidemic, the opioid crisis, presented by Theresa Vettese, MD. Dr. Alfred Burger updates us on Clinical Practice Guidelines, and Jeff Trost, MD, brings us up to speed on the effects of COVID-19 and the heart.
• Thursday, Aug. 20, wraps up week 2 of HM20 Virtual with Population Health by Adam Myers, MD, and Updates in Pneumonia by Joanna Bonsall, MD.

The personal interactions don’t have to stop there! HM20 Virtual also features Special Interest Forums. Check out the list and find out how to join by visiting the HM20 Virtual website.

We look forward to “seeing” you at HM20 Virtual. We always want your feedback; however, in this socially distanced, travel-limited world, your input is more important now than ever. Be sure to let us know how this new format works for your learning, networking, and professional needs.

On behalf of the SHM board of directors, the SHM staff, and myself, we hope you enjoy HM20 Virtual. Through this meeting’s rich selection of educational opportunities – and the innovative approaches in a world dominated by the coronavirus – SHM continues to further its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, empowering hospitalists and transforming patient care.

Dr. Howell is CEO of the Society of Hospital Medicine.

The Society of Hospital Medicine prides itself on bringing a broad range of experts together with the largest gathering of hospitalists at any conference – virtual or otherwise! Hospitalists, nurse practitioners, physician assistants, executives, pharmacists, educators, and practitioners of many hospital-based specialties make HM20 Virtual a unique educational experience.

We know that patients depend on you to have pertinent, updated, and timely information for their acute care needs. HM20 Virtual can provide the information you need to stay abreast in this complex and ever-changing year. From COVID-19 to common diagnosis, from racism/bias to blood glucose, from peds to pulmonary embolism, HM20 Virtual covers important topics for all acute care and hospital clinicians and professionals.

This year’s conference is something new. To meet the ever-changing challenges that the year 2020 has brought all of us, HM20 Virtual has addressed one of the limitations of an online conference: personal interactions. With Simulive sessions, you will have the opportunity to chat with fellow participants and interact with the expert faculty in real time! Of course, all Simulive sessions will be available on demand after the fact for those of you who need alternate times to watch.

Be sure to attend some (or all!) of this week’s Simulive sessions. There is something for everyone:

• On Tuesday, Aug. 18, Sam Brondfield, MD, will discuss oncologic work-ups, and James Kim, MD, will make antibiotics simple (where was Dr. Kim for my medical school training?).
• Wednesday, Aug. 19, circles back to another epidemic, the opioid crisis, presented by Theresa Vettese, MD. Dr. Alfred Burger updates us on Clinical Practice Guidelines, and Jeff Trost, MD, brings us up to speed on the effects of COVID-19 and the heart.
• Thursday, Aug. 20, wraps up week 2 of HM20 Virtual with Population Health by Adam Myers, MD, and Updates in Pneumonia by Joanna Bonsall, MD.

The personal interactions don’t have to stop there! HM20 Virtual also features Special Interest Forums. Check out the list and find out how to join by visiting the HM20 Virtual website.

We look forward to “seeing” you at HM20 Virtual. We always want your feedback; however, in this socially distanced, travel-limited world, your input is more important now than ever. Be sure to let us know how this new format works for your learning, networking, and professional needs.

On behalf of the SHM board of directors, the SHM staff, and myself, we hope you enjoy HM20 Virtual. Through this meeting’s rich selection of educational opportunities – and the innovative approaches in a world dominated by the coronavirus – SHM continues to further its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, empowering hospitalists and transforming patient care.

Dr. Howell is CEO of the Society of Hospital Medicine.