User login
FDA tightens requirements for COVID-19 antibody tests
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.
The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.
When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.
“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.
The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”
At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.
In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.
To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.
Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.
“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”
Sharing Cancer Care Information Across VA Health Care Systems (FULL)
A telementoring program based on the Specialty Care Access Network Extension for Community Healthcare Outcomes model shared information about cancer care across VA health Care systems.
In 2016, the Cancer Care Coordinator at the US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACT) in West Haven partnered with the VA New England Healthcare System to use its telementoring program. The VA Specialty Care Access Network Extension for Community Healthcare Outcomes (VA ECHO) was used to present a series of educational conferences on cancer care. This article describes our experience implementing the program and reviews participant feedback gathered from voluntary surveys.
Background
In 2011, the Veterans Health Administration (VHA) Office of Healthcare Transformation launched VA ECHO, a telementoring program for primary care providers (PCPs) and patient-aligned care team staff. VACT was selected as 1 of 7 hub sites across the US. The VA ECHO system uses video and online technology to provide PCPs with case-based specialist consultation and didactic education. The system enables providers at any VA location to participate in online and telephone conferences in real time. The presentations are recorded and made available online to VA providers through a secure site.
VA ECHO is based on the highly successful Project ECHO model established by Sanjeev Arora and the University of New Mexico in 2007.1 The rationale for Project ECHO was that patient care could be improved by increasing the competence of PCPs in the management of complex diseases by providing access to disease specialists through a case-based learning approach that used technology, which it termed knowledge networks, to connect the PCPs to specialists.
The original model addressed management of hepatitis C in a medically underserved area where half of the population was widely geographically dispersed, making the provision of specialty care challenging. Developers identified 6 characteristics that make a disease appropriate for treatment using the Project ECHO knowledge network model:
- The disease is common;
- Management of the disease is complex;
- Treatment for the disease is evolving;
- The disease has a high societal impact;
- There are serious outcomes if the disease is not treated; and
- Disease management improves outcomes.1
VA ECHO conferences are available to all VA personnel. Staff can subscribe to an e-mail group list to be alerted to conference times and topics. Participants can connect directly to the conference using Microsoft Outlook Lync or Skype (Redmond, WA) and see the slides in real time on their computer as they listen to the presentation. The presentations are recorded, and the slides with audio can be accessed easily on the VA ECHO SharePoint site for download, enabling VA staff to listen to conferences at their convenience (Figure). 
VA Cancer ECHO
The impetus to create a series of talks related to cancer care using VA ECHO was the frequent and often time-consuming requests we received from colleagues at other VA sites for information about areas of cancer care, such as survivorship and cancer care coordination. It was felt that presenting cancer care information as a VA ECHO series would make this information available to a large group of providers at one time, making the method more time effective than sharing the information via one-on-one conversations.
The cancer care coordinator originally conceived this as a 3-part, 1-time series to present work done at VACT in the areas of survivorship, psychosocial distress monitoring, and coordination of cancer care using the VA Cancer Care Tracking System, an online tracking tool. Information about the series was disseminated via VA group e-mail lists for oncology providers and via the existing VA ECHO subscriber invitation process. The 3-presentation series garnered positive feedback and had attendance that ranged from 49 to 75 participants (mean, 60). Participants expressed enthusiasm for the format via e-mail and phone feedback directly to the West Haven staff.
Expansion
The success of this original 3-part series led to a trial of an ongoing Cancer Care Conference series (Conference) using VA ECHO. This was a novel use of VA ECHO and was outside its traditional format, which is geared to discussion of individual cases and clinical knowledge. Nevertheless, this new style of communication has been embraced by a wide range of VA cancer care professionals.
One reason we considered expanding the program was that oncology fit the framework of the original Project ECHO knowledge network model. Cancer is common at the VA, which cares for 175,000 patients with cancer annually.2 The management of cancer is complex involving many disciplines working together, and treatments are constantly changing. In addition, cancer has a high societal impact; there are serious outcomes both in terms of patient survival and patient symptom burden. And lastly, outcomes are improved with proactive disease management that is informed by the most current, evidence-based medicine.
The Conference was conceived as a forum for providers across disciplines to share best practices and discuss common challenges in caring for veterans with cancer. We invited participants to submit proposals for presentations related to cancer care initiatives at their VA sites. Potential speakers across all areas of care for veterans with cancer were invited to submit possible topics for the conference. The submissions were reviewed by the moderators in an effort to create a series of talks on a variety of topics across all aspects of care for oncology patients in the VA. This process of effectively crowd-sourcing educational content inspires providers to think more creatively about their practice and quality improvement projects and has sparked an ongoing dialogue about quality initiatives among VA oncology providers across disciplines and geographic locations. As a result, this approach also has enabled participants to learn from colleagues who work at a wide range of rural and urban VA locations throughout the country and to network with colleagues who are working on similar quality initiatives and challenges related to caring for veterans with cancer.
Program
The first Conference talk was in October 2016. It encompassed ten 1-hour talks during the 2016 to 2017 academic year. Speakers were recruited from the VACT West Haven campus and from several other VA sites nationwide. Topics included survivorship, psychosocial distress, palliative care, cancer navigation, and establishing a clinical trials program.
In its first year, the Conference series had 260 unique attendees representing such disciplines as medicine, nursing, social work, pharmacy, psychology, and clinic administration and representing all 21 Veterans Integrated Services Networks (VISNs). Speakers including oncologists, hepatologists, cancer care coordinators, health psychologists, and a research coordinator gave presentations on psychosocial distress screening and issues, cognitive behavioral therapy for cancer pain, cancer navigation, cancer case tracking, VISN-based liver cancer tumor tracker and liver tumor board, starting a VA-based clinical trial, palliative care, and survivorship.
The Conference accounted for 508 continuing medical education (CME) hours, which accounted for one-third of the total CME hours generated by the VACT West Haven VA ECHO program. Highlights of the talks were presented at the 2017 Association of VA Hematology/Oncology annual meeting in Denver, Colorado.
During the second year of the Conference, speakers were recruited to address new American College of Surgeons Commission on Cancer (CoC) requirements regarding survivorship treatment summaries for a subset of cancer survivors.3 The focus on survivorship was driven by ongoing feedback from participants who were working on initiatives to implement this process at their VA sites and wanted to learn from peers involved in this process throughout the VA system. Several speakers gave talks on implementing survivorship care at their VA and specifically on the use of computerized patient record system templates to create survivorship treatment summaries for veterans in accordance with CoC standards.
Since the first Conference in 2016, the number of unique attendees grew by 20% to 327 in 2018. During its first 2 years, participants have earned a total of 1,095 CME credits through Yale University CME. Conferences are usually broadcast at noon eastern time so that providers can take advantage of sessions during lunch breaks.
Participant Surveys
Attendees were invited to participate in voluntary, anonymous surveys to obtain feedback on and to receive input on topics of interest for future talks. Participants also were asked to comment on resources that they utilized to be updated on practice changes (Table 1). 
The Conference has led to increased awareness of other continuing education opportunities available through VA ECHO-Connecticut. Of survey participants, 20% reported that they had attended other VA ECHO conferences.
The survey samples are self-selecting and may not necessarily be representative of the Conference participants or of the VA oncology interdisciplinary team as a whole; however, the relatively large number of survey participants provides some confidence that these survey results can help inform future planning for this and other continuing education opportunities for VA oncology providers.
An additional online survey was designed to elucidate whether participants were incorporating knowledge gained from the Conference in their cancer care practice. Half of the 32 participants strongly agreed with the following statement: “Participation in the VA Cancer Care Conference has added to my knowledge of information relevant to my practice,” and 13 more agreed with the statement for a total of 90.6% of those surveyed responding affirmatively. Only 3 participants neither agreed nor disagreed, and none disagreed with the statement. More than half of the participants reported that they made changes to their practice or plan to make changes as a result of the Conference.
Conculsion
The VA ECHO program established at the VACT West Haven campus in 2012 now offers regular monthly or bimonthly conferences in 9 specialties: pain, liver/hepatitis C, neurology, nephrology, cardiology, diabetes/endocrinology, mental health and addiction, nursing grand rounds, and cancer care. The VACT ECHO program is led by a medical director, and each specialty has a clinical director who conducts sessions and recruits other specialists from their department.
Teleconferencing can provide opportunities for colleagues living in distant locations to connect; share best practices, common goals, and challenges; and initiate ongoing and lasting relationships. The Conference draws the most diverse audience by discipline of all the VA ECHO conferences hosted at VACT (Table 2). 
Traditionally, the national VA ECHO program has been a forum for specialists to discuss clinical case presentations for the benefit of primary care providers and to deliver didactics about chronic clinical conditions. Our Cancer Care Management VA ECHO has explored new ground by discussing material that has helped sites set up and enhance cancer care clinics and disseminate best practices for cancer survivorship and other aspects of cancer care. As a result, this conference has attracted and provided a forum for the most diverse audience of staff among VA ECHO clinics, with participation from clinic administrators to social workers to primary care providers to tumor registrars.
Through the creation of the Conference, > 300 individuals who care for veterans with cancer have been provided with a regular forum at which to connect with colleagues, receive updates on new treatment options for their patients, and learn about and share best practices specific to VA oncology patients. The VA ECHO technology creates a resource that can be accessed by all VA staff from their desktop computer. The VA ECHO SharePoint saves the slides of the Conference presentations both with and without audio to enable staff who can’t participate in real time to access the information at their convenience.
The Conference has facilitated networking among VA oncology providers who have common interests. Conference participants also have participated in other VA ECHO conferences in disciplines beyond oncology. Participants in the Conference also are encouraged to participate as speakers by presenting quality improvement initiatives at their VA site. This novel approach to generating content for this educational series has led to a dynamic interchange of ideas and increased networking among VA providers related to their practice and quality improvement initiatives at their VA sites. The Conference provides a regular forum for VA staff across a wide range of disciplines to share personal experiences, successes, and frustrations and to get feedback from colleagues.
The Conference combines a structured approach to presenting VA-specific educational content related to cancer care and multiple mechanisms that encourage staff to participate in an ongoing dialogue related to quality initiatives both on the phone during the Conference, online using Outlook LYNC or Skype to ask questions during the Conference, and during conversations on group e-mail. The Conference promotes staff engagement at little or no extra cost to the VA. For more information about the VA ECHO Cancer Care Conference or to submit a presentation for consideration for a future session, please contact [email protected] or [email protected].
1. Arora S, Geppert CM, Kalishman S, et al. Academic health center management of chronic diseases through knowledge networks: Project ECHO. Acad Med. 2007;82(2):154-160.
2. Hematology and oncology federal health care data trends. Fed Pract. 2017;33(suppl 5):S12-S15.
3. American College of Surgeons Commission on Cancer. Cancer Program Standards: Ensuring Patient Centered Care, 2016 Edition. https://www.facs.org/quality-programs/cancer/coc/standards. Accessed March 14, 2018.
A telementoring program based on the Specialty Care Access Network Extension for Community Healthcare Outcomes model shared information about cancer care across VA health Care systems.
A telementoring program based on the Specialty Care Access Network Extension for Community Healthcare Outcomes model shared information about cancer care across VA health Care systems.
In 2016, the Cancer Care Coordinator at the US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACT) in West Haven partnered with the VA New England Healthcare System to use its telementoring program. The VA Specialty Care Access Network Extension for Community Healthcare Outcomes (VA ECHO) was used to present a series of educational conferences on cancer care. This article describes our experience implementing the program and reviews participant feedback gathered from voluntary surveys.
Background
In 2011, the Veterans Health Administration (VHA) Office of Healthcare Transformation launched VA ECHO, a telementoring program for primary care providers (PCPs) and patient-aligned care team staff. VACT was selected as 1 of 7 hub sites across the US. The VA ECHO system uses video and online technology to provide PCPs with case-based specialist consultation and didactic education. The system enables providers at any VA location to participate in online and telephone conferences in real time. The presentations are recorded and made available online to VA providers through a secure site.
VA ECHO is based on the highly successful Project ECHO model established by Sanjeev Arora and the University of New Mexico in 2007.1 The rationale for Project ECHO was that patient care could be improved by increasing the competence of PCPs in the management of complex diseases by providing access to disease specialists through a case-based learning approach that used technology, which it termed knowledge networks, to connect the PCPs to specialists.
The original model addressed management of hepatitis C in a medically underserved area where half of the population was widely geographically dispersed, making the provision of specialty care challenging. Developers identified 6 characteristics that make a disease appropriate for treatment using the Project ECHO knowledge network model:
- The disease is common;
- Management of the disease is complex;
- Treatment for the disease is evolving;
- The disease has a high societal impact;
- There are serious outcomes if the disease is not treated; and
- Disease management improves outcomes.1
VA ECHO conferences are available to all VA personnel. Staff can subscribe to an e-mail group list to be alerted to conference times and topics. Participants can connect directly to the conference using Microsoft Outlook Lync or Skype (Redmond, WA) and see the slides in real time on their computer as they listen to the presentation. The presentations are recorded, and the slides with audio can be accessed easily on the VA ECHO SharePoint site for download, enabling VA staff to listen to conferences at their convenience (Figure).
VA Cancer ECHO
The impetus to create a series of talks related to cancer care using VA ECHO was the frequent and often time-consuming requests we received from colleagues at other VA sites for information about areas of cancer care, such as survivorship and cancer care coordination. It was felt that presenting cancer care information as a VA ECHO series would make this information available to a large group of providers at one time, making the method more time effective than sharing the information via one-on-one conversations.
The cancer care coordinator originally conceived this as a 3-part, 1-time series to present work done at VACT in the areas of survivorship, psychosocial distress monitoring, and coordination of cancer care using the VA Cancer Care Tracking System, an online tracking tool. Information about the series was disseminated via VA group e-mail lists for oncology providers and via the existing VA ECHO subscriber invitation process. The 3-presentation series garnered positive feedback and had attendance that ranged from 49 to 75 participants (mean, 60). Participants expressed enthusiasm for the format via e-mail and phone feedback directly to the West Haven staff.
Expansion
The success of this original 3-part series led to a trial of an ongoing Cancer Care Conference series (Conference) using VA ECHO. This was a novel use of VA ECHO and was outside its traditional format, which is geared to discussion of individual cases and clinical knowledge. Nevertheless, this new style of communication has been embraced by a wide range of VA cancer care professionals.
One reason we considered expanding the program was that oncology fit the framework of the original Project ECHO knowledge network model. Cancer is common at the VA, which cares for 175,000 patients with cancer annually.2 The management of cancer is complex involving many disciplines working together, and treatments are constantly changing. In addition, cancer has a high societal impact; there are serious outcomes both in terms of patient survival and patient symptom burden. And lastly, outcomes are improved with proactive disease management that is informed by the most current, evidence-based medicine.
The Conference was conceived as a forum for providers across disciplines to share best practices and discuss common challenges in caring for veterans with cancer. We invited participants to submit proposals for presentations related to cancer care initiatives at their VA sites. Potential speakers across all areas of care for veterans with cancer were invited to submit possible topics for the conference. The submissions were reviewed by the moderators in an effort to create a series of talks on a variety of topics across all aspects of care for oncology patients in the VA. This process of effectively crowd-sourcing educational content inspires providers to think more creatively about their practice and quality improvement projects and has sparked an ongoing dialogue about quality initiatives among VA oncology providers across disciplines and geographic locations. As a result, this approach also has enabled participants to learn from colleagues who work at a wide range of rural and urban VA locations throughout the country and to network with colleagues who are working on similar quality initiatives and challenges related to caring for veterans with cancer.
Program
The first Conference talk was in October 2016. It encompassed ten 1-hour talks during the 2016 to 2017 academic year. Speakers were recruited from the VACT West Haven campus and from several other VA sites nationwide. Topics included survivorship, psychosocial distress, palliative care, cancer navigation, and establishing a clinical trials program.
In its first year, the Conference series had 260 unique attendees representing such disciplines as medicine, nursing, social work, pharmacy, psychology, and clinic administration and representing all 21 Veterans Integrated Services Networks (VISNs). Speakers including oncologists, hepatologists, cancer care coordinators, health psychologists, and a research coordinator gave presentations on psychosocial distress screening and issues, cognitive behavioral therapy for cancer pain, cancer navigation, cancer case tracking, VISN-based liver cancer tumor tracker and liver tumor board, starting a VA-based clinical trial, palliative care, and survivorship.
The Conference accounted for 508 continuing medical education (CME) hours, which accounted for one-third of the total CME hours generated by the VACT West Haven VA ECHO program. Highlights of the talks were presented at the 2017 Association of VA Hematology/Oncology annual meeting in Denver, Colorado.
During the second year of the Conference, speakers were recruited to address new American College of Surgeons Commission on Cancer (CoC) requirements regarding survivorship treatment summaries for a subset of cancer survivors.3 The focus on survivorship was driven by ongoing feedback from participants who were working on initiatives to implement this process at their VA sites and wanted to learn from peers involved in this process throughout the VA system. Several speakers gave talks on implementing survivorship care at their VA and specifically on the use of computerized patient record system templates to create survivorship treatment summaries for veterans in accordance with CoC standards.
Since the first Conference in 2016, the number of unique attendees grew by 20% to 327 in 2018. During its first 2 years, participants have earned a total of 1,095 CME credits through Yale University CME. Conferences are usually broadcast at noon eastern time so that providers can take advantage of sessions during lunch breaks.
Participant Surveys
Attendees were invited to participate in voluntary, anonymous surveys to obtain feedback on and to receive input on topics of interest for future talks. Participants also were asked to comment on resources that they utilized to be updated on practice changes (Table 1).
The Conference has led to increased awareness of other continuing education opportunities available through VA ECHO-Connecticut. Of survey participants, 20% reported that they had attended other VA ECHO conferences.
The survey samples are self-selecting and may not necessarily be representative of the Conference participants or of the VA oncology interdisciplinary team as a whole; however, the relatively large number of survey participants provides some confidence that these survey results can help inform future planning for this and other continuing education opportunities for VA oncology providers.
An additional online survey was designed to elucidate whether participants were incorporating knowledge gained from the Conference in their cancer care practice. Half of the 32 participants strongly agreed with the following statement: “Participation in the VA Cancer Care Conference has added to my knowledge of information relevant to my practice,” and 13 more agreed with the statement for a total of 90.6% of those surveyed responding affirmatively. Only 3 participants neither agreed nor disagreed, and none disagreed with the statement. More than half of the participants reported that they made changes to their practice or plan to make changes as a result of the Conference.
Conculsion
The VA ECHO program established at the VACT West Haven campus in 2012 now offers regular monthly or bimonthly conferences in 9 specialties: pain, liver/hepatitis C, neurology, nephrology, cardiology, diabetes/endocrinology, mental health and addiction, nursing grand rounds, and cancer care. The VACT ECHO program is led by a medical director, and each specialty has a clinical director who conducts sessions and recruits other specialists from their department.
Teleconferencing can provide opportunities for colleagues living in distant locations to connect; share best practices, common goals, and challenges; and initiate ongoing and lasting relationships. The Conference draws the most diverse audience by discipline of all the VA ECHO conferences hosted at VACT (Table 2).
Traditionally, the national VA ECHO program has been a forum for specialists to discuss clinical case presentations for the benefit of primary care providers and to deliver didactics about chronic clinical conditions. Our Cancer Care Management VA ECHO has explored new ground by discussing material that has helped sites set up and enhance cancer care clinics and disseminate best practices for cancer survivorship and other aspects of cancer care. As a result, this conference has attracted and provided a forum for the most diverse audience of staff among VA ECHO clinics, with participation from clinic administrators to social workers to primary care providers to tumor registrars.
Through the creation of the Conference, > 300 individuals who care for veterans with cancer have been provided with a regular forum at which to connect with colleagues, receive updates on new treatment options for their patients, and learn about and share best practices specific to VA oncology patients. The VA ECHO technology creates a resource that can be accessed by all VA staff from their desktop computer. The VA ECHO SharePoint saves the slides of the Conference presentations both with and without audio to enable staff who can’t participate in real time to access the information at their convenience.
The Conference has facilitated networking among VA oncology providers who have common interests. Conference participants also have participated in other VA ECHO conferences in disciplines beyond oncology. Participants in the Conference also are encouraged to participate as speakers by presenting quality improvement initiatives at their VA site. This novel approach to generating content for this educational series has led to a dynamic interchange of ideas and increased networking among VA providers related to their practice and quality improvement initiatives at their VA sites. The Conference provides a regular forum for VA staff across a wide range of disciplines to share personal experiences, successes, and frustrations and to get feedback from colleagues.
The Conference combines a structured approach to presenting VA-specific educational content related to cancer care and multiple mechanisms that encourage staff to participate in an ongoing dialogue related to quality initiatives both on the phone during the Conference, online using Outlook LYNC or Skype to ask questions during the Conference, and during conversations on group e-mail. The Conference promotes staff engagement at little or no extra cost to the VA. For more information about the VA ECHO Cancer Care Conference or to submit a presentation for consideration for a future session, please contact [email protected] or [email protected].
In 2016, the Cancer Care Coordinator at the US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACT) in West Haven partnered with the VA New England Healthcare System to use its telementoring program. The VA Specialty Care Access Network Extension for Community Healthcare Outcomes (VA ECHO) was used to present a series of educational conferences on cancer care. This article describes our experience implementing the program and reviews participant feedback gathered from voluntary surveys.
Background
In 2011, the Veterans Health Administration (VHA) Office of Healthcare Transformation launched VA ECHO, a telementoring program for primary care providers (PCPs) and patient-aligned care team staff. VACT was selected as 1 of 7 hub sites across the US. The VA ECHO system uses video and online technology to provide PCPs with case-based specialist consultation and didactic education. The system enables providers at any VA location to participate in online and telephone conferences in real time. The presentations are recorded and made available online to VA providers through a secure site.
VA ECHO is based on the highly successful Project ECHO model established by Sanjeev Arora and the University of New Mexico in 2007.1 The rationale for Project ECHO was that patient care could be improved by increasing the competence of PCPs in the management of complex diseases by providing access to disease specialists through a case-based learning approach that used technology, which it termed knowledge networks, to connect the PCPs to specialists.
The original model addressed management of hepatitis C in a medically underserved area where half of the population was widely geographically dispersed, making the provision of specialty care challenging. Developers identified 6 characteristics that make a disease appropriate for treatment using the Project ECHO knowledge network model:
- The disease is common;
- Management of the disease is complex;
- Treatment for the disease is evolving;
- The disease has a high societal impact;
- There are serious outcomes if the disease is not treated; and
- Disease management improves outcomes.1
VA ECHO conferences are available to all VA personnel. Staff can subscribe to an e-mail group list to be alerted to conference times and topics. Participants can connect directly to the conference using Microsoft Outlook Lync or Skype (Redmond, WA) and see the slides in real time on their computer as they listen to the presentation. The presentations are recorded, and the slides with audio can be accessed easily on the VA ECHO SharePoint site for download, enabling VA staff to listen to conferences at their convenience (Figure).
VA Cancer ECHO
The impetus to create a series of talks related to cancer care using VA ECHO was the frequent and often time-consuming requests we received from colleagues at other VA sites for information about areas of cancer care, such as survivorship and cancer care coordination. It was felt that presenting cancer care information as a VA ECHO series would make this information available to a large group of providers at one time, making the method more time effective than sharing the information via one-on-one conversations.
The cancer care coordinator originally conceived this as a 3-part, 1-time series to present work done at VACT in the areas of survivorship, psychosocial distress monitoring, and coordination of cancer care using the VA Cancer Care Tracking System, an online tracking tool. Information about the series was disseminated via VA group e-mail lists for oncology providers and via the existing VA ECHO subscriber invitation process. The 3-presentation series garnered positive feedback and had attendance that ranged from 49 to 75 participants (mean, 60). Participants expressed enthusiasm for the format via e-mail and phone feedback directly to the West Haven staff.
Expansion
The success of this original 3-part series led to a trial of an ongoing Cancer Care Conference series (Conference) using VA ECHO. This was a novel use of VA ECHO and was outside its traditional format, which is geared to discussion of individual cases and clinical knowledge. Nevertheless, this new style of communication has been embraced by a wide range of VA cancer care professionals.
One reason we considered expanding the program was that oncology fit the framework of the original Project ECHO knowledge network model. Cancer is common at the VA, which cares for 175,000 patients with cancer annually.2 The management of cancer is complex involving many disciplines working together, and treatments are constantly changing. In addition, cancer has a high societal impact; there are serious outcomes both in terms of patient survival and patient symptom burden. And lastly, outcomes are improved with proactive disease management that is informed by the most current, evidence-based medicine.
The Conference was conceived as a forum for providers across disciplines to share best practices and discuss common challenges in caring for veterans with cancer. We invited participants to submit proposals for presentations related to cancer care initiatives at their VA sites. Potential speakers across all areas of care for veterans with cancer were invited to submit possible topics for the conference. The submissions were reviewed by the moderators in an effort to create a series of talks on a variety of topics across all aspects of care for oncology patients in the VA. This process of effectively crowd-sourcing educational content inspires providers to think more creatively about their practice and quality improvement projects and has sparked an ongoing dialogue about quality initiatives among VA oncology providers across disciplines and geographic locations. As a result, this approach also has enabled participants to learn from colleagues who work at a wide range of rural and urban VA locations throughout the country and to network with colleagues who are working on similar quality initiatives and challenges related to caring for veterans with cancer.
Program
The first Conference talk was in October 2016. It encompassed ten 1-hour talks during the 2016 to 2017 academic year. Speakers were recruited from the VACT West Haven campus and from several other VA sites nationwide. Topics included survivorship, psychosocial distress, palliative care, cancer navigation, and establishing a clinical trials program.
In its first year, the Conference series had 260 unique attendees representing such disciplines as medicine, nursing, social work, pharmacy, psychology, and clinic administration and representing all 21 Veterans Integrated Services Networks (VISNs). Speakers including oncologists, hepatologists, cancer care coordinators, health psychologists, and a research coordinator gave presentations on psychosocial distress screening and issues, cognitive behavioral therapy for cancer pain, cancer navigation, cancer case tracking, VISN-based liver cancer tumor tracker and liver tumor board, starting a VA-based clinical trial, palliative care, and survivorship.
The Conference accounted for 508 continuing medical education (CME) hours, which accounted for one-third of the total CME hours generated by the VACT West Haven VA ECHO program. Highlights of the talks were presented at the 2017 Association of VA Hematology/Oncology annual meeting in Denver, Colorado.
During the second year of the Conference, speakers were recruited to address new American College of Surgeons Commission on Cancer (CoC) requirements regarding survivorship treatment summaries for a subset of cancer survivors.3 The focus on survivorship was driven by ongoing feedback from participants who were working on initiatives to implement this process at their VA sites and wanted to learn from peers involved in this process throughout the VA system. Several speakers gave talks on implementing survivorship care at their VA and specifically on the use of computerized patient record system templates to create survivorship treatment summaries for veterans in accordance with CoC standards.
Since the first Conference in 2016, the number of unique attendees grew by 20% to 327 in 2018. During its first 2 years, participants have earned a total of 1,095 CME credits through Yale University CME. Conferences are usually broadcast at noon eastern time so that providers can take advantage of sessions during lunch breaks.
Participant Surveys
Attendees were invited to participate in voluntary, anonymous surveys to obtain feedback on and to receive input on topics of interest for future talks. Participants also were asked to comment on resources that they utilized to be updated on practice changes (Table 1).
The Conference has led to increased awareness of other continuing education opportunities available through VA ECHO-Connecticut. Of survey participants, 20% reported that they had attended other VA ECHO conferences.
The survey samples are self-selecting and may not necessarily be representative of the Conference participants or of the VA oncology interdisciplinary team as a whole; however, the relatively large number of survey participants provides some confidence that these survey results can help inform future planning for this and other continuing education opportunities for VA oncology providers.
An additional online survey was designed to elucidate whether participants were incorporating knowledge gained from the Conference in their cancer care practice. Half of the 32 participants strongly agreed with the following statement: “Participation in the VA Cancer Care Conference has added to my knowledge of information relevant to my practice,” and 13 more agreed with the statement for a total of 90.6% of those surveyed responding affirmatively. Only 3 participants neither agreed nor disagreed, and none disagreed with the statement. More than half of the participants reported that they made changes to their practice or plan to make changes as a result of the Conference.
Conculsion
The VA ECHO program established at the VACT West Haven campus in 2012 now offers regular monthly or bimonthly conferences in 9 specialties: pain, liver/hepatitis C, neurology, nephrology, cardiology, diabetes/endocrinology, mental health and addiction, nursing grand rounds, and cancer care. The VACT ECHO program is led by a medical director, and each specialty has a clinical director who conducts sessions and recruits other specialists from their department.
Teleconferencing can provide opportunities for colleagues living in distant locations to connect; share best practices, common goals, and challenges; and initiate ongoing and lasting relationships. The Conference draws the most diverse audience by discipline of all the VA ECHO conferences hosted at VACT (Table 2).
Traditionally, the national VA ECHO program has been a forum for specialists to discuss clinical case presentations for the benefit of primary care providers and to deliver didactics about chronic clinical conditions. Our Cancer Care Management VA ECHO has explored new ground by discussing material that has helped sites set up and enhance cancer care clinics and disseminate best practices for cancer survivorship and other aspects of cancer care. As a result, this conference has attracted and provided a forum for the most diverse audience of staff among VA ECHO clinics, with participation from clinic administrators to social workers to primary care providers to tumor registrars.
Through the creation of the Conference, > 300 individuals who care for veterans with cancer have been provided with a regular forum at which to connect with colleagues, receive updates on new treatment options for their patients, and learn about and share best practices specific to VA oncology patients. The VA ECHO technology creates a resource that can be accessed by all VA staff from their desktop computer. The VA ECHO SharePoint saves the slides of the Conference presentations both with and without audio to enable staff who can’t participate in real time to access the information at their convenience.
The Conference has facilitated networking among VA oncology providers who have common interests. Conference participants also have participated in other VA ECHO conferences in disciplines beyond oncology. Participants in the Conference also are encouraged to participate as speakers by presenting quality improvement initiatives at their VA site. This novel approach to generating content for this educational series has led to a dynamic interchange of ideas and increased networking among VA providers related to their practice and quality improvement initiatives at their VA sites. The Conference provides a regular forum for VA staff across a wide range of disciplines to share personal experiences, successes, and frustrations and to get feedback from colleagues.
The Conference combines a structured approach to presenting VA-specific educational content related to cancer care and multiple mechanisms that encourage staff to participate in an ongoing dialogue related to quality initiatives both on the phone during the Conference, online using Outlook LYNC or Skype to ask questions during the Conference, and during conversations on group e-mail. The Conference promotes staff engagement at little or no extra cost to the VA. For more information about the VA ECHO Cancer Care Conference or to submit a presentation for consideration for a future session, please contact [email protected] or [email protected].
1. Arora S, Geppert CM, Kalishman S, et al. Academic health center management of chronic diseases through knowledge networks: Project ECHO. Acad Med. 2007;82(2):154-160.
2. Hematology and oncology federal health care data trends. Fed Pract. 2017;33(suppl 5):S12-S15.
3. American College of Surgeons Commission on Cancer. Cancer Program Standards: Ensuring Patient Centered Care, 2016 Edition. https://www.facs.org/quality-programs/cancer/coc/standards. Accessed March 14, 2018.
1. Arora S, Geppert CM, Kalishman S, et al. Academic health center management of chronic diseases through knowledge networks: Project ECHO. Acad Med. 2007;82(2):154-160.
2. Hematology and oncology federal health care data trends. Fed Pract. 2017;33(suppl 5):S12-S15.
3. American College of Surgeons Commission on Cancer. Cancer Program Standards: Ensuring Patient Centered Care, 2016 Edition. https://www.facs.org/quality-programs/cancer/coc/standards. Accessed March 14, 2018.
COVID-19: An opportunity, challenge for addiction treatment, NIDA boss says
The COVID-19 pandemic is posing significant challenges while also providing unique opportunities for patients with substance use disorders (SUD), a leading expert says.
Nora Volkow, MD, director of the National Institute on Drug Abuse, said that the pandemic has accelerated the use of telemedicine, making it easier for patients with SUD to access treatment. It has also led to the proliferation of more mental health hotlines, which is critical since the vast majority of these patients have comorbid mental illness.
In addition, COVID-19 has resulted in increased availability of “alternative” peer support mechanisms via cellphones or computers to aid individuals’ sobriety.
Dr. Volkow spoke at the virtual American Psychiatric Association Spring Highlights Meeting 2020, which is replacing the organization’s canceled annual meeting.
While methadone clinics have had to close during the pandemic, making it challenging for those on medically assisted treatment to receive methadone or buprenorphine, some of the rules and regulations have been relaxed in order to make these medications accessible without the need for in-person attendance at a clinic. In addition, the Substance Abuse and Mental Health Services Administration has relaxed some of its own regulations regarding telehealth and opioid treatment programs.
Social isolation, stigma intensified
A pandemic increases anxiety in the general population, but for patients with SUD who may be also be struggling with homelessness and comorbid mental illness, the situation can further exacerbate social stigma and isolation – leading to relapse, more overdoses, and overdose deaths, Dr. Volkow said. Social interaction is “extraordinarily important” for patients and “one of the most powerful tools we have” to build resilience.
Right now, said Dr. Volkow, “we are in the dark as to how COVID infections have affected the number of overdose deaths.”
However, she noted that
“So even through this devastation, we can actually extract something that may help others in future,” she said.
Dr. Volkow noted that during the pandemic it is critical to reinforce the importance of engaging in – and remaining in – treatment to SUD patients. It’s also crucial to make patients aware of social support systems and behavioral interventions to help them cope with stress and to mitigate relapse risk.
COVID-19 and relapse
Elie G. Aoun, MD, assistant professor of psychiatry at New York University and vice chair of the APA’s Council on Addiction Psychiatry, said in an interview that Dr. Volkow’s presentation provided “exactly the kind of accessible information” clinicians need.
Dr. Aoun said he sees the impact of the COVID-19 crisis in his practice every day. Patients with SUD “are getting the short end of the stick.”
Social distancing measures prompted by the pandemic can be “very triggering” for SUD patients, he said. One of his patients told him the current isolation, loneliness, movement restrictions, and boredom remind her of the way she felt when she used drugs.
Dr. Aoun said four of his patients have relapsed since the pandemic began. Two of them had just started treatment after years of using drugs, so this was a “major setback” for them.
He and his colleagues were “not really prepared” to provide care via video link, which he believes is not as effective as in-person sessions.
In addition to disrupting patient care, said Dr. Aoun, the pandemic is forcing the medical community to face social determinants of health, such as poverty and homelessness, as they relate to addiction disorders and whether or not someone receives care.
This article originally appeared on Medscape.com.
The COVID-19 pandemic is posing significant challenges while also providing unique opportunities for patients with substance use disorders (SUD), a leading expert says.
Nora Volkow, MD, director of the National Institute on Drug Abuse, said that the pandemic has accelerated the use of telemedicine, making it easier for patients with SUD to access treatment. It has also led to the proliferation of more mental health hotlines, which is critical since the vast majority of these patients have comorbid mental illness.
In addition, COVID-19 has resulted in increased availability of “alternative” peer support mechanisms via cellphones or computers to aid individuals’ sobriety.
Dr. Volkow spoke at the virtual American Psychiatric Association Spring Highlights Meeting 2020, which is replacing the organization’s canceled annual meeting.
While methadone clinics have had to close during the pandemic, making it challenging for those on medically assisted treatment to receive methadone or buprenorphine, some of the rules and regulations have been relaxed in order to make these medications accessible without the need for in-person attendance at a clinic. In addition, the Substance Abuse and Mental Health Services Administration has relaxed some of its own regulations regarding telehealth and opioid treatment programs.
Social isolation, stigma intensified
A pandemic increases anxiety in the general population, but for patients with SUD who may be also be struggling with homelessness and comorbid mental illness, the situation can further exacerbate social stigma and isolation – leading to relapse, more overdoses, and overdose deaths, Dr. Volkow said. Social interaction is “extraordinarily important” for patients and “one of the most powerful tools we have” to build resilience.
Right now, said Dr. Volkow, “we are in the dark as to how COVID infections have affected the number of overdose deaths.”
However, she noted that
“So even through this devastation, we can actually extract something that may help others in future,” she said.
Dr. Volkow noted that during the pandemic it is critical to reinforce the importance of engaging in – and remaining in – treatment to SUD patients. It’s also crucial to make patients aware of social support systems and behavioral interventions to help them cope with stress and to mitigate relapse risk.
COVID-19 and relapse
Elie G. Aoun, MD, assistant professor of psychiatry at New York University and vice chair of the APA’s Council on Addiction Psychiatry, said in an interview that Dr. Volkow’s presentation provided “exactly the kind of accessible information” clinicians need.
Dr. Aoun said he sees the impact of the COVID-19 crisis in his practice every day. Patients with SUD “are getting the short end of the stick.”
Social distancing measures prompted by the pandemic can be “very triggering” for SUD patients, he said. One of his patients told him the current isolation, loneliness, movement restrictions, and boredom remind her of the way she felt when she used drugs.
Dr. Aoun said four of his patients have relapsed since the pandemic began. Two of them had just started treatment after years of using drugs, so this was a “major setback” for them.
He and his colleagues were “not really prepared” to provide care via video link, which he believes is not as effective as in-person sessions.
In addition to disrupting patient care, said Dr. Aoun, the pandemic is forcing the medical community to face social determinants of health, such as poverty and homelessness, as they relate to addiction disorders and whether or not someone receives care.
This article originally appeared on Medscape.com.
The COVID-19 pandemic is posing significant challenges while also providing unique opportunities for patients with substance use disorders (SUD), a leading expert says.
Nora Volkow, MD, director of the National Institute on Drug Abuse, said that the pandemic has accelerated the use of telemedicine, making it easier for patients with SUD to access treatment. It has also led to the proliferation of more mental health hotlines, which is critical since the vast majority of these patients have comorbid mental illness.
In addition, COVID-19 has resulted in increased availability of “alternative” peer support mechanisms via cellphones or computers to aid individuals’ sobriety.
Dr. Volkow spoke at the virtual American Psychiatric Association Spring Highlights Meeting 2020, which is replacing the organization’s canceled annual meeting.
While methadone clinics have had to close during the pandemic, making it challenging for those on medically assisted treatment to receive methadone or buprenorphine, some of the rules and regulations have been relaxed in order to make these medications accessible without the need for in-person attendance at a clinic. In addition, the Substance Abuse and Mental Health Services Administration has relaxed some of its own regulations regarding telehealth and opioid treatment programs.
Social isolation, stigma intensified
A pandemic increases anxiety in the general population, but for patients with SUD who may be also be struggling with homelessness and comorbid mental illness, the situation can further exacerbate social stigma and isolation – leading to relapse, more overdoses, and overdose deaths, Dr. Volkow said. Social interaction is “extraordinarily important” for patients and “one of the most powerful tools we have” to build resilience.
Right now, said Dr. Volkow, “we are in the dark as to how COVID infections have affected the number of overdose deaths.”
However, she noted that
“So even through this devastation, we can actually extract something that may help others in future,” she said.
Dr. Volkow noted that during the pandemic it is critical to reinforce the importance of engaging in – and remaining in – treatment to SUD patients. It’s also crucial to make patients aware of social support systems and behavioral interventions to help them cope with stress and to mitigate relapse risk.
COVID-19 and relapse
Elie G. Aoun, MD, assistant professor of psychiatry at New York University and vice chair of the APA’s Council on Addiction Psychiatry, said in an interview that Dr. Volkow’s presentation provided “exactly the kind of accessible information” clinicians need.
Dr. Aoun said he sees the impact of the COVID-19 crisis in his practice every day. Patients with SUD “are getting the short end of the stick.”
Social distancing measures prompted by the pandemic can be “very triggering” for SUD patients, he said. One of his patients told him the current isolation, loneliness, movement restrictions, and boredom remind her of the way she felt when she used drugs.
Dr. Aoun said four of his patients have relapsed since the pandemic began. Two of them had just started treatment after years of using drugs, so this was a “major setback” for them.
He and his colleagues were “not really prepared” to provide care via video link, which he believes is not as effective as in-person sessions.
In addition to disrupting patient care, said Dr. Aoun, the pandemic is forcing the medical community to face social determinants of health, such as poverty and homelessness, as they relate to addiction disorders and whether or not someone receives care.
This article originally appeared on Medscape.com.
FDA reiterates hydroxychloroquine limitations for COVID-19
The U.S. Food and Drug Administration reinforced its March guidance on when it’s permissible to use hydroxychloroquine and chloroquine to treat COVID-19 patients and on the multiple risks these drugs pose in a Safety Communication on April 24.
The new communication reiterated the agency’s position from the Emergency Use Authorization (EUA) it granted on March 28 to allow hydroxychloroquine and chloroquine treatment of COVID-19 patients only when they are hospitalized and participation in a clinical trial is “not available,” or “not feasible.” The April 24 update to the EUA noted that “the FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT-prolonging medicines. We are also aware of increased use of these medicines through outpatient prescriptions.”
In addition to reiterating the prior limitations on permissible patients for these treatment the agency also said in the new communication that “close supervision is strongly recommended, “ specifying that “we recommend initial evaluation and monitoring when using hydroxychloroquine or chloroquine under the EUA or in clinical trials that investigate these medicines for the treatment or prevention of COVID-19. Monitoring may include baseline ECG, electrolytes, renal function, and hepatic tests.” The communication also highlighted several potential serious adverse effects from hydroxychloroquine or chloroquine that include QT prolongation with increased risk in patients with renal insufficiency or failure, increased insulin levels and insulin action causing increased risk of severe hypoglycemia, hemolysis in selected patients, and interaction with other medicines that cause QT prolongation.
“If a healthcare professional is considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19, FDA recommends checking www.clinicaltrials.gov for a suitable clinical trial and consider enrolling the patient,” the statement added.
The FDA’s Safety Communication came a day after the European Medicines Agency issued a similar reminder about the risk for serious adverse effects from treatment with hydroxychloroquine and chloroquine, the need for adverse effect monitoring, and the unproven status of purported benefits from these agents.
The statement came after ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite a lack of evidence.
The FDA’s communication cited recent case reports sent to the FDA, as well as published findings, and reports to the National Poison Data System that have described serious, heart-related adverse events and death in COVID-19 patients who received hydroxychloroquine and chloroquine, alone or in combination with azithromycin or another QT-prolonging drug. One recent, notable but not peer-reviewed report on 368 patients treated at any of several U.S. VA medical centers showed no apparent benefit to hospitalized COVID-19 patients treated with hydroxychloroquine and a signal for increased mortality among certain patients on this drug (medRxiv. 2020 Apr 23; doi: 10.1101/2020.04.16.20065920). Several cardiology societies have also highlighted the cardiac considerations for using these drugs in patients with COVID-19, including a summary coauthored by the presidents of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society (Circulation. 2020 Apr 8. doi: 10.1161/CIRCULATIONAHA.120.047521), and in guidance from the European Society of Cardiology.
The U.S. Food and Drug Administration reinforced its March guidance on when it’s permissible to use hydroxychloroquine and chloroquine to treat COVID-19 patients and on the multiple risks these drugs pose in a Safety Communication on April 24.
The new communication reiterated the agency’s position from the Emergency Use Authorization (EUA) it granted on March 28 to allow hydroxychloroquine and chloroquine treatment of COVID-19 patients only when they are hospitalized and participation in a clinical trial is “not available,” or “not feasible.” The April 24 update to the EUA noted that “the FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT-prolonging medicines. We are also aware of increased use of these medicines through outpatient prescriptions.”
In addition to reiterating the prior limitations on permissible patients for these treatment the agency also said in the new communication that “close supervision is strongly recommended, “ specifying that “we recommend initial evaluation and monitoring when using hydroxychloroquine or chloroquine under the EUA or in clinical trials that investigate these medicines for the treatment or prevention of COVID-19. Monitoring may include baseline ECG, electrolytes, renal function, and hepatic tests.” The communication also highlighted several potential serious adverse effects from hydroxychloroquine or chloroquine that include QT prolongation with increased risk in patients with renal insufficiency or failure, increased insulin levels and insulin action causing increased risk of severe hypoglycemia, hemolysis in selected patients, and interaction with other medicines that cause QT prolongation.
“If a healthcare professional is considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19, FDA recommends checking www.clinicaltrials.gov for a suitable clinical trial and consider enrolling the patient,” the statement added.
The FDA’s Safety Communication came a day after the European Medicines Agency issued a similar reminder about the risk for serious adverse effects from treatment with hydroxychloroquine and chloroquine, the need for adverse effect monitoring, and the unproven status of purported benefits from these agents.
The statement came after ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite a lack of evidence.
The FDA’s communication cited recent case reports sent to the FDA, as well as published findings, and reports to the National Poison Data System that have described serious, heart-related adverse events and death in COVID-19 patients who received hydroxychloroquine and chloroquine, alone or in combination with azithromycin or another QT-prolonging drug. One recent, notable but not peer-reviewed report on 368 patients treated at any of several U.S. VA medical centers showed no apparent benefit to hospitalized COVID-19 patients treated with hydroxychloroquine and a signal for increased mortality among certain patients on this drug (medRxiv. 2020 Apr 23; doi: 10.1101/2020.04.16.20065920). Several cardiology societies have also highlighted the cardiac considerations for using these drugs in patients with COVID-19, including a summary coauthored by the presidents of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society (Circulation. 2020 Apr 8. doi: 10.1161/CIRCULATIONAHA.120.047521), and in guidance from the European Society of Cardiology.
The U.S. Food and Drug Administration reinforced its March guidance on when it’s permissible to use hydroxychloroquine and chloroquine to treat COVID-19 patients and on the multiple risks these drugs pose in a Safety Communication on April 24.
The new communication reiterated the agency’s position from the Emergency Use Authorization (EUA) it granted on March 28 to allow hydroxychloroquine and chloroquine treatment of COVID-19 patients only when they are hospitalized and participation in a clinical trial is “not available,” or “not feasible.” The April 24 update to the EUA noted that “the FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT-prolonging medicines. We are also aware of increased use of these medicines through outpatient prescriptions.”
In addition to reiterating the prior limitations on permissible patients for these treatment the agency also said in the new communication that “close supervision is strongly recommended, “ specifying that “we recommend initial evaluation and monitoring when using hydroxychloroquine or chloroquine under the EUA or in clinical trials that investigate these medicines for the treatment or prevention of COVID-19. Monitoring may include baseline ECG, electrolytes, renal function, and hepatic tests.” The communication also highlighted several potential serious adverse effects from hydroxychloroquine or chloroquine that include QT prolongation with increased risk in patients with renal insufficiency or failure, increased insulin levels and insulin action causing increased risk of severe hypoglycemia, hemolysis in selected patients, and interaction with other medicines that cause QT prolongation.
“If a healthcare professional is considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19, FDA recommends checking www.clinicaltrials.gov for a suitable clinical trial and consider enrolling the patient,” the statement added.
The FDA’s Safety Communication came a day after the European Medicines Agency issued a similar reminder about the risk for serious adverse effects from treatment with hydroxychloroquine and chloroquine, the need for adverse effect monitoring, and the unproven status of purported benefits from these agents.
The statement came after ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite a lack of evidence.
The FDA’s communication cited recent case reports sent to the FDA, as well as published findings, and reports to the National Poison Data System that have described serious, heart-related adverse events and death in COVID-19 patients who received hydroxychloroquine and chloroquine, alone or in combination with azithromycin or another QT-prolonging drug. One recent, notable but not peer-reviewed report on 368 patients treated at any of several U.S. VA medical centers showed no apparent benefit to hospitalized COVID-19 patients treated with hydroxychloroquine and a signal for increased mortality among certain patients on this drug (medRxiv. 2020 Apr 23; doi: 10.1101/2020.04.16.20065920). Several cardiology societies have also highlighted the cardiac considerations for using these drugs in patients with COVID-19, including a summary coauthored by the presidents of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society (Circulation. 2020 Apr 8. doi: 10.1161/CIRCULATIONAHA.120.047521), and in guidance from the European Society of Cardiology.
FROM THE FDA
Steps to leadership during the COVID-19 era and beyond
SARS CoV-2 (severe acute respiratory syndrome corona-
virus 2) has challenged us all and will continue to do so for at least the next several months. This novel virus has uncovered our medical hubris and our collective failure to acknowledge our vulnerability in the face of biological threats. As government, public health, health systems, medical professionals, and individuals struggle to grasp its enormous impact, we must recognize and seize the opportunities for leadership that the coronavirus disease (COVID-19) pandemic presents to us as physicians.
For too long we have abdicated responsibility for driving change in the US health system to politicians, administrators, and those not on the front line of care delivery. We can, however, reclaim our voice and position of influence in 2 primary spheres: first, as ObGyns we have the specific clinical knowledge and experience required to help guide our institutions in the care of our patients under new and ever-changing circumstances; second, beyond our clinical role as ObGyns, we are servant leaders to whom the public, the government, our trainees, and our clinical teams turn for guidance.
Foundations for policy development
Disaster planning in hospitals and public health systems rarely includes consideration for pregnant and delivering patients. As ObGyns, we must create policies and procedures using the best available evidence—which is slim—and, in the absence of evidence, use our clinical and scientific expertise both to optimize patient care and to minimize risk to the health care team.
At this point in time there is much we do not know, such as whether viral particles in blood are contagious, amniotic fluid contains infectious droplets, or newborns are in danger if they room-in with an infected mother. What we do know is that the evidence will evolve and that our policies and procedures must be fluid and allow for rapid change. Here are some guiding principles for such policies.
Maximize telemedicine and remote monitoring
Labor and delivery (L&D) is an emergency department in which people are triaged from the outside. Systems should incorporate the best guidance from the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists while reducing infection exposure to staff, laboring patients, and newborns. One way to limit traffic in the triage area is to have a seasoned clinician perform phone triage for women who think they need evaluation for labor.
Maintain universal caution and precautions
All people entering L&D should be presumed to be COVID-19 positive, according to early evidence reported from Columbia University in New York City.1 After remote or off-site phone triage determines that evaluation is needed in L&D, a transporter could ensure that all people escorted to L&D undergo a rapid COVID-19 test, wear a mask, and wash their hands. Until point-of-care testing is available, we must adopt safety precautions, since current data suggest that asymptomatic people may shed the infectious virus.
Both vaginal and cesarean deliveries expose everyone in the room to respiratory droplets. Common sense tells us that the laboring patient and her support person should wear a mask and that caregivers should be protected with N95 masks as well as face shields. If this were standard for every laboring patient, exposure during emergency situations might be minimized.
Continue to: Maximize support during labor...
Maximize support during labor
We should not need to ban partners and support people. Solid evidence demonstrates that support in labor improves outcomes, reduces the need for cesarean delivery, and increases patient satisfaction. We can and should protect staff and patients by requiring everyone to wear a mask.
Symptomatic patients, of course, require additional measures and personal protective equipment (PPE) to reduce the risk of infection among the health care team. These should be identical to the measures the hospital infectious disease experts have implemented in the intensive care unit.
Champion continuous quality improvement
It is our responsibility to implement continuous quality improvement processes so that we can respond to data that become available, and this begins with collecting our own local data.
We have sparse data on the risks of miscarriage, congenital anomalies, and preterm birth, but there have been anecdotal reports of both early miscarriage and premature labor. Given the known increased risk for severe disease with influenza during pregnancy, we understandably are concerned about how our pregnant patients will fare. There are also unknowns with respect to fetal exposure risk. During this pandemic we must capture such data within our own systems and share aggregated, de-identified data broadly and swiftly if real signals indicate a need for change in procedures or policy.
In the meantime, we can apply our expertise and best judgment to work within teams that include all stakeholders—administrators, nurses, engineers, pediatricians, infectious disease experts, and public members—to establish policies that respond to the best current evidence.
Protect vulnerable team members
SARS CoV-2 is highly contagious. Thus far, data do not suggest that pregnant women are at higher risk for severe disease, but we must assume that working in the hospital environment among many COVID-19 patients increases the risk for exposure. With so many current unknowns, it may be prudent to keep pregnant health care workers out of clinical areas in the hospital and reassign them to other duties when feasible. Medical students nationwide similarly have been removed from clinical rotations to minimize their exposure risk as well as to preserve scarce PPE.
These decisions are difficult for all involved, and shared decision making between administrators, clinical leaders, and pregnant staff that promotes transparency, honesty, and openness is key. Since the risk is unknown and financial consequences may result for both the hospital and the staff member, open discussion and thoughtful policies that can be revised as new information is obtained will help achieve the best possible resolution to a difficult situation.
Continue to: ObGyns as servant leaders...
ObGyns as servant leaders
COVID-19 challenges us to balance individual and public health considerations while also considering the economic and social consequences of actions. The emergence of this novel pathogen and its rapid global spread are frightening both to an uninformed public and to our skeptical government officials. Beyond our immediate clinical responsibilities, how should we as knowledgeable professionals respond?
Servant leaders commit to service and support and mentor those around them with empathy and collaboration. Servant leaders have the strategic vision to continuously grow, change, and improve at all times, but especially during a crisis. COVID-19 challenges us to be those servant leaders. To do so we must:
Promote and exhibit transparency by speaking truth to power and communicating with empathy for patients, staff, and those on the front lines who daily place themselves and their families at risk to ensure that we have essential services. Amplifying the needs and concerns of the frontline workers can drive those in power to develop practical and useful solutions.
Nurses and physicians have been threatened, and some actually terminated from their positions, because they publicly disclosed their institutions’ working conditions, lack of PPE, and unpreparedness. For example, a decorated US Navy captain was stripped of his command for writing a letter to drive action in managing a COVID-19 outbreak on the confined quarters of his ship. Such public health heroes have exhibited professionalism and leadership, placing the health and well-being of their colleagues, peers, and patients above their own careers. If we all spoke up with honesty and openness, we could have profound impact.
Hold ourselves and others accountable for scientific rigor and honesty. We must acknowledge what we do not know and be straightforward in discussing risks and benefits. The uncertainty surrounding the COVID-19 public health crisis has created anxiety among health care workers, public-facing workers, government officials, and the public. We should not speculate but rather speak clearly and openly about our knowledge deficits.
The US culture in health care drives us to prefer action over inaction. “Doing something” feels proactive, and we are conditioned to think of doing something as a less risky strategy than watchful waiting. In this time of uncertainty, we must be wary of unproven and potentially harmful interventions, and we must use our best judgment and expertise to study procedures and medications that have potential benefit.
Be collaborative and creative in crafting practical workarounds that can be implemented at scale. New processes implemented in the past month to accommodate our new socially and physically distant reality include telemedicine for prenatal care, home monitoring of blood pressure, remote physiologic monitoring of blood sugars for diabetic patients, reviewing digital images to provide remote wound care, and home pulse oximetry to assess COVID-19–positive patients at home.
More workarounds are needed to support women’s ongoing health needs. Our expertise should guide those strategies while we strive to optimize outcomes, minimize resource utilization, and reduce exposure risk for ourselves, our staff, and our patients.
Advocate for systems to collect and analyze robust data so we can adjust interventions rapidly as new information arises. As we navigate the pandemic, the lack of evidence to inform decisions and treatment challenges us daily. We should use the current crisis to promote strategies that will support rapid, comprehensive data collection during disasters. Knowledge truly is power, and without it we are forced to improvise and speculate.
ObGyns must insist that data collection includes all pregnancies—not only those positive for COVID-19 since the testing has been sporadic and imperfect—and that the data are stratified by age, gender, race and ethnicity, and sociodemographics. This would enable us to learn as much as possible as quickly as possible and would therefore inform our responses for the current SARS CoV-2 pandemic as well as for the next disaster.
Continue to: Acknowledge the limitations of the system...
Acknowledge the limitations of the system and be wise stewards of resources. Our health care system does not have sufficient resources to manage patients with severe COVID-19 and the “usual” emergencies like stroke, myocardial infarction, ectopic pregnancy, and broken bones.
Disaster planning should include a regional triage system that can take incoming calls and direct emergency medical technicians, ambulances, and private citizens to appropriate facilities and direct those who do not require urgent medical care away from those facilities.
We must incorporate principles from battlefield medicine, because this is a battle, and we are at war. That means there will be difficult decisions. It is better to engage a regional team of experts to create a system for triage and care delivery than for each provider and institution to be forced by a void in leadership to go it individually. We should engage with government and public health officials to optimize both cure and care. Although we are unable to save everyone, we can work to ensure comfort and care for all.
Demonstrate compassion and caring for patients and each other. During the COVID-19 pandemic crisis, we can each channel our best selves to support and protect each other physically and emotionally. Many of us chose ObGyn because it is generally a “happy” specialty. None of us entered medicine to watch people die or to be unable to comfort them, to be unable to allow their families to be with them, to be unable to “do something.”
A crucial part of disaster planning and response is to prepare for the second victims: those of us forced to keep going through our emotional distress because there is no time to debrief and process our pain. Frontline caregivers need support and help now as well as after the surge passes. We need to speak up to ensure there is adequate PPE, creative staffing, and supportive resources to help caregivers process their anxiety, fatigue, and distress.
Take the lead
Every crisis brings both risk and opportunity. The COVID-19 pandemic provides ObGyns the chance to have a louder voice and a meaningful seat at the table as new and creative policies must be implemented at every level. We can use this opportunity to recapture our roles as champions for women and leaders within our health care system.
Critical steps in servant leadership include speaking up with honesty, transparency, and openness; taking risks to disclose inequities, dangerous conditions, and inadequate resources; and committing ourselves to each other, our teams, and the public. When we take these steps, we will be the driving force for a cohesive, reasoned, structured, and compassionate response to the COVID-19 crisis. As we seize this opportunity to lead, we will rekindle our passion for medicine, caring for the sick, and protecting the well. ●
- Sutton D, Fuchs K, D’Alton M, et al. Universal screening for SARS-CoV-2 in women admitted for delivery [letter]. N Engl J Med. April 13, 2020. doi:10.1056/NEJMc2009316.
Barbara Levy, MD
Clinical Professor, Obstetrics and Gynecology
The George Washington University
School of Medicine and Health Sciences
Washington, DC
Principal, The Levy Group LLC
Member, OBG MANAGEMENT Board of Editors
The author reports no financial relationships relevant to this article.
Barbara Levy, MD
Clinical Professor, Obstetrics and Gynecology
The George Washington University
School of Medicine and Health Sciences
Washington, DC
Principal, The Levy Group LLC
Member, OBG MANAGEMENT Board of Editors
The author reports no financial relationships relevant to this article.
Barbara Levy, MD
Clinical Professor, Obstetrics and Gynecology
The George Washington University
School of Medicine and Health Sciences
Washington, DC
Principal, The Levy Group LLC
Member, OBG MANAGEMENT Board of Editors
The author reports no financial relationships relevant to this article.
SARS CoV-2 (severe acute respiratory syndrome corona-
virus 2) has challenged us all and will continue to do so for at least the next several months. This novel virus has uncovered our medical hubris and our collective failure to acknowledge our vulnerability in the face of biological threats. As government, public health, health systems, medical professionals, and individuals struggle to grasp its enormous impact, we must recognize and seize the opportunities for leadership that the coronavirus disease (COVID-19) pandemic presents to us as physicians.
For too long we have abdicated responsibility for driving change in the US health system to politicians, administrators, and those not on the front line of care delivery. We can, however, reclaim our voice and position of influence in 2 primary spheres: first, as ObGyns we have the specific clinical knowledge and experience required to help guide our institutions in the care of our patients under new and ever-changing circumstances; second, beyond our clinical role as ObGyns, we are servant leaders to whom the public, the government, our trainees, and our clinical teams turn for guidance.
Foundations for policy development
Disaster planning in hospitals and public health systems rarely includes consideration for pregnant and delivering patients. As ObGyns, we must create policies and procedures using the best available evidence—which is slim—and, in the absence of evidence, use our clinical and scientific expertise both to optimize patient care and to minimize risk to the health care team.
At this point in time there is much we do not know, such as whether viral particles in blood are contagious, amniotic fluid contains infectious droplets, or newborns are in danger if they room-in with an infected mother. What we do know is that the evidence will evolve and that our policies and procedures must be fluid and allow for rapid change. Here are some guiding principles for such policies.
Maximize telemedicine and remote monitoring
Labor and delivery (L&D) is an emergency department in which people are triaged from the outside. Systems should incorporate the best guidance from the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists while reducing infection exposure to staff, laboring patients, and newborns. One way to limit traffic in the triage area is to have a seasoned clinician perform phone triage for women who think they need evaluation for labor.
Maintain universal caution and precautions
All people entering L&D should be presumed to be COVID-19 positive, according to early evidence reported from Columbia University in New York City.1 After remote or off-site phone triage determines that evaluation is needed in L&D, a transporter could ensure that all people escorted to L&D undergo a rapid COVID-19 test, wear a mask, and wash their hands. Until point-of-care testing is available, we must adopt safety precautions, since current data suggest that asymptomatic people may shed the infectious virus.
Both vaginal and cesarean deliveries expose everyone in the room to respiratory droplets. Common sense tells us that the laboring patient and her support person should wear a mask and that caregivers should be protected with N95 masks as well as face shields. If this were standard for every laboring patient, exposure during emergency situations might be minimized.
Continue to: Maximize support during labor...
Maximize support during labor
We should not need to ban partners and support people. Solid evidence demonstrates that support in labor improves outcomes, reduces the need for cesarean delivery, and increases patient satisfaction. We can and should protect staff and patients by requiring everyone to wear a mask.
Symptomatic patients, of course, require additional measures and personal protective equipment (PPE) to reduce the risk of infection among the health care team. These should be identical to the measures the hospital infectious disease experts have implemented in the intensive care unit.
Champion continuous quality improvement
It is our responsibility to implement continuous quality improvement processes so that we can respond to data that become available, and this begins with collecting our own local data.
We have sparse data on the risks of miscarriage, congenital anomalies, and preterm birth, but there have been anecdotal reports of both early miscarriage and premature labor. Given the known increased risk for severe disease with influenza during pregnancy, we understandably are concerned about how our pregnant patients will fare. There are also unknowns with respect to fetal exposure risk. During this pandemic we must capture such data within our own systems and share aggregated, de-identified data broadly and swiftly if real signals indicate a need for change in procedures or policy.
In the meantime, we can apply our expertise and best judgment to work within teams that include all stakeholders—administrators, nurses, engineers, pediatricians, infectious disease experts, and public members—to establish policies that respond to the best current evidence.
Protect vulnerable team members
SARS CoV-2 is highly contagious. Thus far, data do not suggest that pregnant women are at higher risk for severe disease, but we must assume that working in the hospital environment among many COVID-19 patients increases the risk for exposure. With so many current unknowns, it may be prudent to keep pregnant health care workers out of clinical areas in the hospital and reassign them to other duties when feasible. Medical students nationwide similarly have been removed from clinical rotations to minimize their exposure risk as well as to preserve scarce PPE.
These decisions are difficult for all involved, and shared decision making between administrators, clinical leaders, and pregnant staff that promotes transparency, honesty, and openness is key. Since the risk is unknown and financial consequences may result for both the hospital and the staff member, open discussion and thoughtful policies that can be revised as new information is obtained will help achieve the best possible resolution to a difficult situation.
Continue to: ObGyns as servant leaders...
ObGyns as servant leaders
COVID-19 challenges us to balance individual and public health considerations while also considering the economic and social consequences of actions. The emergence of this novel pathogen and its rapid global spread are frightening both to an uninformed public and to our skeptical government officials. Beyond our immediate clinical responsibilities, how should we as knowledgeable professionals respond?
Servant leaders commit to service and support and mentor those around them with empathy and collaboration. Servant leaders have the strategic vision to continuously grow, change, and improve at all times, but especially during a crisis. COVID-19 challenges us to be those servant leaders. To do so we must:
Promote and exhibit transparency by speaking truth to power and communicating with empathy for patients, staff, and those on the front lines who daily place themselves and their families at risk to ensure that we have essential services. Amplifying the needs and concerns of the frontline workers can drive those in power to develop practical and useful solutions.
Nurses and physicians have been threatened, and some actually terminated from their positions, because they publicly disclosed their institutions’ working conditions, lack of PPE, and unpreparedness. For example, a decorated US Navy captain was stripped of his command for writing a letter to drive action in managing a COVID-19 outbreak on the confined quarters of his ship. Such public health heroes have exhibited professionalism and leadership, placing the health and well-being of their colleagues, peers, and patients above their own careers. If we all spoke up with honesty and openness, we could have profound impact.
Hold ourselves and others accountable for scientific rigor and honesty. We must acknowledge what we do not know and be straightforward in discussing risks and benefits. The uncertainty surrounding the COVID-19 public health crisis has created anxiety among health care workers, public-facing workers, government officials, and the public. We should not speculate but rather speak clearly and openly about our knowledge deficits.
The US culture in health care drives us to prefer action over inaction. “Doing something” feels proactive, and we are conditioned to think of doing something as a less risky strategy than watchful waiting. In this time of uncertainty, we must be wary of unproven and potentially harmful interventions, and we must use our best judgment and expertise to study procedures and medications that have potential benefit.
Be collaborative and creative in crafting practical workarounds that can be implemented at scale. New processes implemented in the past month to accommodate our new socially and physically distant reality include telemedicine for prenatal care, home monitoring of blood pressure, remote physiologic monitoring of blood sugars for diabetic patients, reviewing digital images to provide remote wound care, and home pulse oximetry to assess COVID-19–positive patients at home.
More workarounds are needed to support women’s ongoing health needs. Our expertise should guide those strategies while we strive to optimize outcomes, minimize resource utilization, and reduce exposure risk for ourselves, our staff, and our patients.
Advocate for systems to collect and analyze robust data so we can adjust interventions rapidly as new information arises. As we navigate the pandemic, the lack of evidence to inform decisions and treatment challenges us daily. We should use the current crisis to promote strategies that will support rapid, comprehensive data collection during disasters. Knowledge truly is power, and without it we are forced to improvise and speculate.
ObGyns must insist that data collection includes all pregnancies—not only those positive for COVID-19 since the testing has been sporadic and imperfect—and that the data are stratified by age, gender, race and ethnicity, and sociodemographics. This would enable us to learn as much as possible as quickly as possible and would therefore inform our responses for the current SARS CoV-2 pandemic as well as for the next disaster.
Continue to: Acknowledge the limitations of the system...
Acknowledge the limitations of the system and be wise stewards of resources. Our health care system does not have sufficient resources to manage patients with severe COVID-19 and the “usual” emergencies like stroke, myocardial infarction, ectopic pregnancy, and broken bones.
Disaster planning should include a regional triage system that can take incoming calls and direct emergency medical technicians, ambulances, and private citizens to appropriate facilities and direct those who do not require urgent medical care away from those facilities.
We must incorporate principles from battlefield medicine, because this is a battle, and we are at war. That means there will be difficult decisions. It is better to engage a regional team of experts to create a system for triage and care delivery than for each provider and institution to be forced by a void in leadership to go it individually. We should engage with government and public health officials to optimize both cure and care. Although we are unable to save everyone, we can work to ensure comfort and care for all.
Demonstrate compassion and caring for patients and each other. During the COVID-19 pandemic crisis, we can each channel our best selves to support and protect each other physically and emotionally. Many of us chose ObGyn because it is generally a “happy” specialty. None of us entered medicine to watch people die or to be unable to comfort them, to be unable to allow their families to be with them, to be unable to “do something.”
A crucial part of disaster planning and response is to prepare for the second victims: those of us forced to keep going through our emotional distress because there is no time to debrief and process our pain. Frontline caregivers need support and help now as well as after the surge passes. We need to speak up to ensure there is adequate PPE, creative staffing, and supportive resources to help caregivers process their anxiety, fatigue, and distress.
Take the lead
Every crisis brings both risk and opportunity. The COVID-19 pandemic provides ObGyns the chance to have a louder voice and a meaningful seat at the table as new and creative policies must be implemented at every level. We can use this opportunity to recapture our roles as champions for women and leaders within our health care system.
Critical steps in servant leadership include speaking up with honesty, transparency, and openness; taking risks to disclose inequities, dangerous conditions, and inadequate resources; and committing ourselves to each other, our teams, and the public. When we take these steps, we will be the driving force for a cohesive, reasoned, structured, and compassionate response to the COVID-19 crisis. As we seize this opportunity to lead, we will rekindle our passion for medicine, caring for the sick, and protecting the well. ●
SARS CoV-2 (severe acute respiratory syndrome corona-
virus 2) has challenged us all and will continue to do so for at least the next several months. This novel virus has uncovered our medical hubris and our collective failure to acknowledge our vulnerability in the face of biological threats. As government, public health, health systems, medical professionals, and individuals struggle to grasp its enormous impact, we must recognize and seize the opportunities for leadership that the coronavirus disease (COVID-19) pandemic presents to us as physicians.
For too long we have abdicated responsibility for driving change in the US health system to politicians, administrators, and those not on the front line of care delivery. We can, however, reclaim our voice and position of influence in 2 primary spheres: first, as ObGyns we have the specific clinical knowledge and experience required to help guide our institutions in the care of our patients under new and ever-changing circumstances; second, beyond our clinical role as ObGyns, we are servant leaders to whom the public, the government, our trainees, and our clinical teams turn for guidance.
Foundations for policy development
Disaster planning in hospitals and public health systems rarely includes consideration for pregnant and delivering patients. As ObGyns, we must create policies and procedures using the best available evidence—which is slim—and, in the absence of evidence, use our clinical and scientific expertise both to optimize patient care and to minimize risk to the health care team.
At this point in time there is much we do not know, such as whether viral particles in blood are contagious, amniotic fluid contains infectious droplets, or newborns are in danger if they room-in with an infected mother. What we do know is that the evidence will evolve and that our policies and procedures must be fluid and allow for rapid change. Here are some guiding principles for such policies.
Maximize telemedicine and remote monitoring
Labor and delivery (L&D) is an emergency department in which people are triaged from the outside. Systems should incorporate the best guidance from the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists while reducing infection exposure to staff, laboring patients, and newborns. One way to limit traffic in the triage area is to have a seasoned clinician perform phone triage for women who think they need evaluation for labor.
Maintain universal caution and precautions
All people entering L&D should be presumed to be COVID-19 positive, according to early evidence reported from Columbia University in New York City.1 After remote or off-site phone triage determines that evaluation is needed in L&D, a transporter could ensure that all people escorted to L&D undergo a rapid COVID-19 test, wear a mask, and wash their hands. Until point-of-care testing is available, we must adopt safety precautions, since current data suggest that asymptomatic people may shed the infectious virus.
Both vaginal and cesarean deliveries expose everyone in the room to respiratory droplets. Common sense tells us that the laboring patient and her support person should wear a mask and that caregivers should be protected with N95 masks as well as face shields. If this were standard for every laboring patient, exposure during emergency situations might be minimized.
Continue to: Maximize support during labor...
Maximize support during labor
We should not need to ban partners and support people. Solid evidence demonstrates that support in labor improves outcomes, reduces the need for cesarean delivery, and increases patient satisfaction. We can and should protect staff and patients by requiring everyone to wear a mask.
Symptomatic patients, of course, require additional measures and personal protective equipment (PPE) to reduce the risk of infection among the health care team. These should be identical to the measures the hospital infectious disease experts have implemented in the intensive care unit.
Champion continuous quality improvement
It is our responsibility to implement continuous quality improvement processes so that we can respond to data that become available, and this begins with collecting our own local data.
We have sparse data on the risks of miscarriage, congenital anomalies, and preterm birth, but there have been anecdotal reports of both early miscarriage and premature labor. Given the known increased risk for severe disease with influenza during pregnancy, we understandably are concerned about how our pregnant patients will fare. There are also unknowns with respect to fetal exposure risk. During this pandemic we must capture such data within our own systems and share aggregated, de-identified data broadly and swiftly if real signals indicate a need for change in procedures or policy.
In the meantime, we can apply our expertise and best judgment to work within teams that include all stakeholders—administrators, nurses, engineers, pediatricians, infectious disease experts, and public members—to establish policies that respond to the best current evidence.
Protect vulnerable team members
SARS CoV-2 is highly contagious. Thus far, data do not suggest that pregnant women are at higher risk for severe disease, but we must assume that working in the hospital environment among many COVID-19 patients increases the risk for exposure. With so many current unknowns, it may be prudent to keep pregnant health care workers out of clinical areas in the hospital and reassign them to other duties when feasible. Medical students nationwide similarly have been removed from clinical rotations to minimize their exposure risk as well as to preserve scarce PPE.
These decisions are difficult for all involved, and shared decision making between administrators, clinical leaders, and pregnant staff that promotes transparency, honesty, and openness is key. Since the risk is unknown and financial consequences may result for both the hospital and the staff member, open discussion and thoughtful policies that can be revised as new information is obtained will help achieve the best possible resolution to a difficult situation.
Continue to: ObGyns as servant leaders...
ObGyns as servant leaders
COVID-19 challenges us to balance individual and public health considerations while also considering the economic and social consequences of actions. The emergence of this novel pathogen and its rapid global spread are frightening both to an uninformed public and to our skeptical government officials. Beyond our immediate clinical responsibilities, how should we as knowledgeable professionals respond?
Servant leaders commit to service and support and mentor those around them with empathy and collaboration. Servant leaders have the strategic vision to continuously grow, change, and improve at all times, but especially during a crisis. COVID-19 challenges us to be those servant leaders. To do so we must:
Promote and exhibit transparency by speaking truth to power and communicating with empathy for patients, staff, and those on the front lines who daily place themselves and their families at risk to ensure that we have essential services. Amplifying the needs and concerns of the frontline workers can drive those in power to develop practical and useful solutions.
Nurses and physicians have been threatened, and some actually terminated from their positions, because they publicly disclosed their institutions’ working conditions, lack of PPE, and unpreparedness. For example, a decorated US Navy captain was stripped of his command for writing a letter to drive action in managing a COVID-19 outbreak on the confined quarters of his ship. Such public health heroes have exhibited professionalism and leadership, placing the health and well-being of their colleagues, peers, and patients above their own careers. If we all spoke up with honesty and openness, we could have profound impact.
Hold ourselves and others accountable for scientific rigor and honesty. We must acknowledge what we do not know and be straightforward in discussing risks and benefits. The uncertainty surrounding the COVID-19 public health crisis has created anxiety among health care workers, public-facing workers, government officials, and the public. We should not speculate but rather speak clearly and openly about our knowledge deficits.
The US culture in health care drives us to prefer action over inaction. “Doing something” feels proactive, and we are conditioned to think of doing something as a less risky strategy than watchful waiting. In this time of uncertainty, we must be wary of unproven and potentially harmful interventions, and we must use our best judgment and expertise to study procedures and medications that have potential benefit.
Be collaborative and creative in crafting practical workarounds that can be implemented at scale. New processes implemented in the past month to accommodate our new socially and physically distant reality include telemedicine for prenatal care, home monitoring of blood pressure, remote physiologic monitoring of blood sugars for diabetic patients, reviewing digital images to provide remote wound care, and home pulse oximetry to assess COVID-19–positive patients at home.
More workarounds are needed to support women’s ongoing health needs. Our expertise should guide those strategies while we strive to optimize outcomes, minimize resource utilization, and reduce exposure risk for ourselves, our staff, and our patients.
Advocate for systems to collect and analyze robust data so we can adjust interventions rapidly as new information arises. As we navigate the pandemic, the lack of evidence to inform decisions and treatment challenges us daily. We should use the current crisis to promote strategies that will support rapid, comprehensive data collection during disasters. Knowledge truly is power, and without it we are forced to improvise and speculate.
ObGyns must insist that data collection includes all pregnancies—not only those positive for COVID-19 since the testing has been sporadic and imperfect—and that the data are stratified by age, gender, race and ethnicity, and sociodemographics. This would enable us to learn as much as possible as quickly as possible and would therefore inform our responses for the current SARS CoV-2 pandemic as well as for the next disaster.
Continue to: Acknowledge the limitations of the system...
Acknowledge the limitations of the system and be wise stewards of resources. Our health care system does not have sufficient resources to manage patients with severe COVID-19 and the “usual” emergencies like stroke, myocardial infarction, ectopic pregnancy, and broken bones.
Disaster planning should include a regional triage system that can take incoming calls and direct emergency medical technicians, ambulances, and private citizens to appropriate facilities and direct those who do not require urgent medical care away from those facilities.
We must incorporate principles from battlefield medicine, because this is a battle, and we are at war. That means there will be difficult decisions. It is better to engage a regional team of experts to create a system for triage and care delivery than for each provider and institution to be forced by a void in leadership to go it individually. We should engage with government and public health officials to optimize both cure and care. Although we are unable to save everyone, we can work to ensure comfort and care for all.
Demonstrate compassion and caring for patients and each other. During the COVID-19 pandemic crisis, we can each channel our best selves to support and protect each other physically and emotionally. Many of us chose ObGyn because it is generally a “happy” specialty. None of us entered medicine to watch people die or to be unable to comfort them, to be unable to allow their families to be with them, to be unable to “do something.”
A crucial part of disaster planning and response is to prepare for the second victims: those of us forced to keep going through our emotional distress because there is no time to debrief and process our pain. Frontline caregivers need support and help now as well as after the surge passes. We need to speak up to ensure there is adequate PPE, creative staffing, and supportive resources to help caregivers process their anxiety, fatigue, and distress.
Take the lead
Every crisis brings both risk and opportunity. The COVID-19 pandemic provides ObGyns the chance to have a louder voice and a meaningful seat at the table as new and creative policies must be implemented at every level. We can use this opportunity to recapture our roles as champions for women and leaders within our health care system.
Critical steps in servant leadership include speaking up with honesty, transparency, and openness; taking risks to disclose inequities, dangerous conditions, and inadequate resources; and committing ourselves to each other, our teams, and the public. When we take these steps, we will be the driving force for a cohesive, reasoned, structured, and compassionate response to the COVID-19 crisis. As we seize this opportunity to lead, we will rekindle our passion for medicine, caring for the sick, and protecting the well. ●
- Sutton D, Fuchs K, D’Alton M, et al. Universal screening for SARS-CoV-2 in women admitted for delivery [letter]. N Engl J Med. April 13, 2020. doi:10.1056/NEJMc2009316.
- Sutton D, Fuchs K, D’Alton M, et al. Universal screening for SARS-CoV-2 in women admitted for delivery [letter]. N Engl J Med. April 13, 2020. doi:10.1056/NEJMc2009316.
Hydroxychloroquine Debate Rages in Federal Medicine
Hydroxychloroquine, which has been touted without definitive scientific support as a treatment for COVID-19 infection, has special significance for the millions of US military service members and veterans who served in Southwest Asia and other countries with endemic malaria: It’s a critical antimalarial drugs. It’s also needed for US Department of Veterans Affairs (VA) patients with rheumatoid arthritis.
On March 24, the VA Inspector General (IG) surveyed VA medical facilities to determine shortages in equipment as well as “antibiotics, sedatives, pain, and antiviral medications,” although there no known effective treatments for COVID-19. The OIG reported that 12 facilities indicated that they anticipated a shortage of medications, including hydroxychloroquine, lopinavir/ritonavir, IV immunoglobulin, and nebulizer products in the next 14 to 28 days. Facilities in West Haven, CT; Martinsburg, WV; Baltimore, MD; Washington, DC; Durham, NC; Columbia, SC; Tampa, FL; Detroit, MI; Temple, TX; Oklahoma City, OK; Aurora, CO; Seattle, WA; and Phoenix, AZ, all indicated anticipated shortages. At least one facility explicitly worried about access to medications and supplies produced in China and concern about disrupted supply chains may have concerned other facilities as well.
Nevertheless, hydroxychloroquine was at the top of mind both OIG inspectors as well as Veterans Health Administration (VHA) officials. In a formal response to the OIG survey, the VHA asserted: “We object to OIG’s assertions that a 14-day supply of chloroquine or hydroxychloroquine would have any merit. This is both inaccurate and irresponsible. There are active investigations into these drugs and many others, as discussed by Dr. Anthony Fauci. Yet no conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”
Hydroxychloroquine has been associated with serious adverse effects, such as cardiac arrhythmias and hypoglycemia, and its use against COVID-19 is based, so far, on thin evidence. It has shown promise in a laboratory setting against SARS-CoV-2, the virus that causes COVID-19, and in small studies with patients. Nonetheless, the Food and Drug Administration (FDA) has granted limited emergency authorization for certain uses of chloroquine and hydroxychloroquine against COVID-19. The rapid approval came apparently at the behest of the White House.
Former FDA leaders say the authorization has jeopardized research to learn the drugs’ real value in pandemic patients. They also charge that the decision undermines FDA’s scientific authority because it appears to be reacting to political advocacy.
Despite the concerns, a run on chloroquine and hydroxychloroquine has been underway. According to a March 20 blog post by Premier, a hospital purchasing organization, orders for chloroquine and hydroxychloroquine jumped “dramatically” between March 1 and March 17, by 3,000% and 260%, respectively. Fortunately, these are older, relatively inexpensive oral drugs, Premier says, which means their manufacturing is “far less complicated” than for other drugs. To offer immediate help, Premier notes, drug makers such as Teva and Bayer have announced they will donate millions of tablets of the drugs to hospitals or the federal government for further testing.
Owing to “extraordinary public interest” in the off-label use of these drugs, numerous state boards of pharmacy have enacted emergency restrictions on the inappropriate dispensing of chloroquine and hydroxychloroquine, says the Quinism Foundation, a nonprofit organization that supports education and research on medical conditions caused by chloroquine and related drugs. And because of the very real potential for substitution of more dangerous quinolines (such as mefloquine) in place of chloroquine and hydroxychloroquine, the foundation recently called on state boards of pharmacy to enact uniform restrictions on the dispensing of all quinoline antimalarial drugs, with the understanding that any emergency use of any of these medications for public health purposes as attempted pandemic countermeasures would be best coordinated nationally through distribution from the Strategic National Stockpile.
In the meantime, research into hydroxychloroquine’s effectiveness is ongoing. “Coming at it from every angle”—that’s how Terry Welch, spokesman for the Walter Reed Army Institute of Research told Task & Purpose the Army is “leveraging specific competencies” to attack the COVID-19 problem. Among other things, WRAIR’s Emerging Infectious Diseases Branch (EIDB) is working to develop a vaccine against COVID-19 infection, including several versions of a novel vaccine candidate that has been tested in humans. WRAIR has also been conducting research into novel treatments, such as drug candidates similar to those successfully developed to treat malaria, and monoclonal antibodies.
WRAI was able to start its anti-COVID-19 research in early January—directly on the heels of the first reported cases of infection—because of the Institute’s history of researching related viruses. “If we hadn’t done that, we’d be weeks behind,” said Dr. Kayvon Modjarrad, director of EIDB.
The National Institutes of Health (NIH) has also begun a clinical trial, the Outcomes Related to COVID-19 treated with hydroxychloroquine among in-patients with symptomatic Diseases (ORCHID) study. The study will enroll more than 500 adults who are hospitalized with COVID-19 or in an emergency department awaiting hospitalization. All patients will continue to receive clinical care; some will be randomly assigned to also receive hydroxychloroquine. The first participants have been enrolled at Vanderbilt University Medical Center, in Nashville, one of the centers in the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network.
In the “urgent race to find effective therapies,” NIH also launched the first clinical trial in the US to evaluate remdesivir, a broad-spectrum antiviral, as a potential treatment for COVID-19. The trial, which started March 6 at the University of Nebraska Medical Center, is expected to conclude in May. Clinical trials of remdesivir have been ongoing in China, where the virus originated. The NIH study “takes into account” those trial designs.
Many US hospitals are already using hydroxychloroquine as first-line therapy for COVID-19 patients, despite the lack of supportive clinical evidence. Wesley Self, MD, MPH, lead investigator in the ORCHID trial, says “[D]ata on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”
Not only research is needed, but clear expression of the facts about the drugs. In March, shortly after the president began lauding hydroxychloroquine, a Phoenix man died of cardiac arrest and his wife ended up in critical care after they misguidedly ingested chloroquine phosphate, a chemical used to clean fish tanks. “[W]e understand that people are trying to find new ways to prevent or treat this virus,” said Dr. Daniel Brooks, medical director of the Banner Poison and Drug Information Center in Phoenix, “but self-medicating is not the way to do so.”
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and one of the main spokespersons for science in the hydroxychloroquine debate, has continued to try to make his concerns clear: “I think we’ve got to be careful that we don’t make that majestic leap to assume this is a knockout drug,” he said in late March. “We still need to do the kinds of studies that definitively prove whether any intervention—not just this one, any intervention—is truly safe and effective.”
Hydroxychloroquine, which has been touted without definitive scientific support as a treatment for COVID-19 infection, has special significance for the millions of US military service members and veterans who served in Southwest Asia and other countries with endemic malaria: It’s a critical antimalarial drugs. It’s also needed for US Department of Veterans Affairs (VA) patients with rheumatoid arthritis.
On March 24, the VA Inspector General (IG) surveyed VA medical facilities to determine shortages in equipment as well as “antibiotics, sedatives, pain, and antiviral medications,” although there no known effective treatments for COVID-19. The OIG reported that 12 facilities indicated that they anticipated a shortage of medications, including hydroxychloroquine, lopinavir/ritonavir, IV immunoglobulin, and nebulizer products in the next 14 to 28 days. Facilities in West Haven, CT; Martinsburg, WV; Baltimore, MD; Washington, DC; Durham, NC; Columbia, SC; Tampa, FL; Detroit, MI; Temple, TX; Oklahoma City, OK; Aurora, CO; Seattle, WA; and Phoenix, AZ, all indicated anticipated shortages. At least one facility explicitly worried about access to medications and supplies produced in China and concern about disrupted supply chains may have concerned other facilities as well.
Nevertheless, hydroxychloroquine was at the top of mind both OIG inspectors as well as Veterans Health Administration (VHA) officials. In a formal response to the OIG survey, the VHA asserted: “We object to OIG’s assertions that a 14-day supply of chloroquine or hydroxychloroquine would have any merit. This is both inaccurate and irresponsible. There are active investigations into these drugs and many others, as discussed by Dr. Anthony Fauci. Yet no conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”
Hydroxychloroquine has been associated with serious adverse effects, such as cardiac arrhythmias and hypoglycemia, and its use against COVID-19 is based, so far, on thin evidence. It has shown promise in a laboratory setting against SARS-CoV-2, the virus that causes COVID-19, and in small studies with patients. Nonetheless, the Food and Drug Administration (FDA) has granted limited emergency authorization for certain uses of chloroquine and hydroxychloroquine against COVID-19. The rapid approval came apparently at the behest of the White House.
Former FDA leaders say the authorization has jeopardized research to learn the drugs’ real value in pandemic patients. They also charge that the decision undermines FDA’s scientific authority because it appears to be reacting to political advocacy.
Despite the concerns, a run on chloroquine and hydroxychloroquine has been underway. According to a March 20 blog post by Premier, a hospital purchasing organization, orders for chloroquine and hydroxychloroquine jumped “dramatically” between March 1 and March 17, by 3,000% and 260%, respectively. Fortunately, these are older, relatively inexpensive oral drugs, Premier says, which means their manufacturing is “far less complicated” than for other drugs. To offer immediate help, Premier notes, drug makers such as Teva and Bayer have announced they will donate millions of tablets of the drugs to hospitals or the federal government for further testing.
Owing to “extraordinary public interest” in the off-label use of these drugs, numerous state boards of pharmacy have enacted emergency restrictions on the inappropriate dispensing of chloroquine and hydroxychloroquine, says the Quinism Foundation, a nonprofit organization that supports education and research on medical conditions caused by chloroquine and related drugs. And because of the very real potential for substitution of more dangerous quinolines (such as mefloquine) in place of chloroquine and hydroxychloroquine, the foundation recently called on state boards of pharmacy to enact uniform restrictions on the dispensing of all quinoline antimalarial drugs, with the understanding that any emergency use of any of these medications for public health purposes as attempted pandemic countermeasures would be best coordinated nationally through distribution from the Strategic National Stockpile.
In the meantime, research into hydroxychloroquine’s effectiveness is ongoing. “Coming at it from every angle”—that’s how Terry Welch, spokesman for the Walter Reed Army Institute of Research told Task & Purpose the Army is “leveraging specific competencies” to attack the COVID-19 problem. Among other things, WRAIR’s Emerging Infectious Diseases Branch (EIDB) is working to develop a vaccine against COVID-19 infection, including several versions of a novel vaccine candidate that has been tested in humans. WRAIR has also been conducting research into novel treatments, such as drug candidates similar to those successfully developed to treat malaria, and monoclonal antibodies.
WRAI was able to start its anti-COVID-19 research in early January—directly on the heels of the first reported cases of infection—because of the Institute’s history of researching related viruses. “If we hadn’t done that, we’d be weeks behind,” said Dr. Kayvon Modjarrad, director of EIDB.
The National Institutes of Health (NIH) has also begun a clinical trial, the Outcomes Related to COVID-19 treated with hydroxychloroquine among in-patients with symptomatic Diseases (ORCHID) study. The study will enroll more than 500 adults who are hospitalized with COVID-19 or in an emergency department awaiting hospitalization. All patients will continue to receive clinical care; some will be randomly assigned to also receive hydroxychloroquine. The first participants have been enrolled at Vanderbilt University Medical Center, in Nashville, one of the centers in the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network.
In the “urgent race to find effective therapies,” NIH also launched the first clinical trial in the US to evaluate remdesivir, a broad-spectrum antiviral, as a potential treatment for COVID-19. The trial, which started March 6 at the University of Nebraska Medical Center, is expected to conclude in May. Clinical trials of remdesivir have been ongoing in China, where the virus originated. The NIH study “takes into account” those trial designs.
Many US hospitals are already using hydroxychloroquine as first-line therapy for COVID-19 patients, despite the lack of supportive clinical evidence. Wesley Self, MD, MPH, lead investigator in the ORCHID trial, says “[D]ata on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”
Not only research is needed, but clear expression of the facts about the drugs. In March, shortly after the president began lauding hydroxychloroquine, a Phoenix man died of cardiac arrest and his wife ended up in critical care after they misguidedly ingested chloroquine phosphate, a chemical used to clean fish tanks. “[W]e understand that people are trying to find new ways to prevent or treat this virus,” said Dr. Daniel Brooks, medical director of the Banner Poison and Drug Information Center in Phoenix, “but self-medicating is not the way to do so.”
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and one of the main spokespersons for science in the hydroxychloroquine debate, has continued to try to make his concerns clear: “I think we’ve got to be careful that we don’t make that majestic leap to assume this is a knockout drug,” he said in late March. “We still need to do the kinds of studies that definitively prove whether any intervention—not just this one, any intervention—is truly safe and effective.”
Hydroxychloroquine, which has been touted without definitive scientific support as a treatment for COVID-19 infection, has special significance for the millions of US military service members and veterans who served in Southwest Asia and other countries with endemic malaria: It’s a critical antimalarial drugs. It’s also needed for US Department of Veterans Affairs (VA) patients with rheumatoid arthritis.
On March 24, the VA Inspector General (IG) surveyed VA medical facilities to determine shortages in equipment as well as “antibiotics, sedatives, pain, and antiviral medications,” although there no known effective treatments for COVID-19. The OIG reported that 12 facilities indicated that they anticipated a shortage of medications, including hydroxychloroquine, lopinavir/ritonavir, IV immunoglobulin, and nebulizer products in the next 14 to 28 days. Facilities in West Haven, CT; Martinsburg, WV; Baltimore, MD; Washington, DC; Durham, NC; Columbia, SC; Tampa, FL; Detroit, MI; Temple, TX; Oklahoma City, OK; Aurora, CO; Seattle, WA; and Phoenix, AZ, all indicated anticipated shortages. At least one facility explicitly worried about access to medications and supplies produced in China and concern about disrupted supply chains may have concerned other facilities as well.
Nevertheless, hydroxychloroquine was at the top of mind both OIG inspectors as well as Veterans Health Administration (VHA) officials. In a formal response to the OIG survey, the VHA asserted: “We object to OIG’s assertions that a 14-day supply of chloroquine or hydroxychloroquine would have any merit. This is both inaccurate and irresponsible. There are active investigations into these drugs and many others, as discussed by Dr. Anthony Fauci. Yet no conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”
Hydroxychloroquine has been associated with serious adverse effects, such as cardiac arrhythmias and hypoglycemia, and its use against COVID-19 is based, so far, on thin evidence. It has shown promise in a laboratory setting against SARS-CoV-2, the virus that causes COVID-19, and in small studies with patients. Nonetheless, the Food and Drug Administration (FDA) has granted limited emergency authorization for certain uses of chloroquine and hydroxychloroquine against COVID-19. The rapid approval came apparently at the behest of the White House.
Former FDA leaders say the authorization has jeopardized research to learn the drugs’ real value in pandemic patients. They also charge that the decision undermines FDA’s scientific authority because it appears to be reacting to political advocacy.
Despite the concerns, a run on chloroquine and hydroxychloroquine has been underway. According to a March 20 blog post by Premier, a hospital purchasing organization, orders for chloroquine and hydroxychloroquine jumped “dramatically” between March 1 and March 17, by 3,000% and 260%, respectively. Fortunately, these are older, relatively inexpensive oral drugs, Premier says, which means their manufacturing is “far less complicated” than for other drugs. To offer immediate help, Premier notes, drug makers such as Teva and Bayer have announced they will donate millions of tablets of the drugs to hospitals or the federal government for further testing.
Owing to “extraordinary public interest” in the off-label use of these drugs, numerous state boards of pharmacy have enacted emergency restrictions on the inappropriate dispensing of chloroquine and hydroxychloroquine, says the Quinism Foundation, a nonprofit organization that supports education and research on medical conditions caused by chloroquine and related drugs. And because of the very real potential for substitution of more dangerous quinolines (such as mefloquine) in place of chloroquine and hydroxychloroquine, the foundation recently called on state boards of pharmacy to enact uniform restrictions on the dispensing of all quinoline antimalarial drugs, with the understanding that any emergency use of any of these medications for public health purposes as attempted pandemic countermeasures would be best coordinated nationally through distribution from the Strategic National Stockpile.
In the meantime, research into hydroxychloroquine’s effectiveness is ongoing. “Coming at it from every angle”—that’s how Terry Welch, spokesman for the Walter Reed Army Institute of Research told Task & Purpose the Army is “leveraging specific competencies” to attack the COVID-19 problem. Among other things, WRAIR’s Emerging Infectious Diseases Branch (EIDB) is working to develop a vaccine against COVID-19 infection, including several versions of a novel vaccine candidate that has been tested in humans. WRAIR has also been conducting research into novel treatments, such as drug candidates similar to those successfully developed to treat malaria, and monoclonal antibodies.
WRAI was able to start its anti-COVID-19 research in early January—directly on the heels of the first reported cases of infection—because of the Institute’s history of researching related viruses. “If we hadn’t done that, we’d be weeks behind,” said Dr. Kayvon Modjarrad, director of EIDB.
The National Institutes of Health (NIH) has also begun a clinical trial, the Outcomes Related to COVID-19 treated with hydroxychloroquine among in-patients with symptomatic Diseases (ORCHID) study. The study will enroll more than 500 adults who are hospitalized with COVID-19 or in an emergency department awaiting hospitalization. All patients will continue to receive clinical care; some will be randomly assigned to also receive hydroxychloroquine. The first participants have been enrolled at Vanderbilt University Medical Center, in Nashville, one of the centers in the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network.
In the “urgent race to find effective therapies,” NIH also launched the first clinical trial in the US to evaluate remdesivir, a broad-spectrum antiviral, as a potential treatment for COVID-19. The trial, which started March 6 at the University of Nebraska Medical Center, is expected to conclude in May. Clinical trials of remdesivir have been ongoing in China, where the virus originated. The NIH study “takes into account” those trial designs.
Many US hospitals are already using hydroxychloroquine as first-line therapy for COVID-19 patients, despite the lack of supportive clinical evidence. Wesley Self, MD, MPH, lead investigator in the ORCHID trial, says “[D]ata on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”
Not only research is needed, but clear expression of the facts about the drugs. In March, shortly after the president began lauding hydroxychloroquine, a Phoenix man died of cardiac arrest and his wife ended up in critical care after they misguidedly ingested chloroquine phosphate, a chemical used to clean fish tanks. “[W]e understand that people are trying to find new ways to prevent or treat this virus,” said Dr. Daniel Brooks, medical director of the Banner Poison and Drug Information Center in Phoenix, “but self-medicating is not the way to do so.”
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and one of the main spokespersons for science in the hydroxychloroquine debate, has continued to try to make his concerns clear: “I think we’ve got to be careful that we don’t make that majestic leap to assume this is a knockout drug,” he said in late March. “We still need to do the kinds of studies that definitively prove whether any intervention—not just this one, any intervention—is truly safe and effective.”
Observations From Embedded Health Engagement Team Members
“Whenever possible, we will develop innovative, low-cost, and small-footprint approaches to achieve our security objectives.” 1
Team member and participant observations can deliver valuable insight into the effectiveness of an activity or project. Certainly, documentation of such qualitative assessment through survey questions or narratives can reveal important information for future action. This qualitative aspect was a significant consideration in the formation of an embedded health engagement team (EHET) intended to improve foreign assistance and health outcomes for global humanitarian and security cooperation activities.
Since health activities are centered on human interaction and relationships, some observation or qualitative assessment must be included to truly determine short-term local buy-in and long-term outcomes. The following observations include the direct narrative perspectives of team members from a multidisciplinary primary care EHET that add experiential depth to prior assessment of the pilot test of such teams during Continuing Promise 2011, a 9-country series of health engagement activities employed from the USNS Comfort.2 The embedded team consisted of US Air Force (USAF), US Navy (USN), and nongovernmental organization (NGO) personnel working directly in a primary care clinic of the Costa Rican public health system.
This is small sample of a few team members who responded to a simple, open-ended prompt to record their impression of the EHET concept and experiences. Documenting this information should highlight the importance of seeking similar qualitative mission data for future health engagements. Standardized questionnaires have been used to evaluate health activities and have provided valuable analysis and recommendations that have advanced US Department of Defense (DoD) global health engagement.3 Captured narrative observation from the EHET pilot study is a complementary qualitative method that supports the concept of small, well prepared, culturally competent, EHETs tailored to work within a partner system rather than outside of it will achieve greater mutual benefit, including the application of better, more equitable health and health system principles.4 In this embedded manner, health care professionals may readily contribute to host nation health sector plans and goals while achieving military objectives, political goals, and mutual strategic interests through both military-military and military-civilian applications.
Observations and Reflections
Family Physician (Maj, Second Physician, USAF)
“Overall, the experience I had with the embedded team was truly rewarding. I hope this becomes a tool used to augment humanitarian missions. There is no way to truly understand a systems strengths and weakness except by being embedded in the clinic or hospital. For 3 days I worked alongside a bilingual physician at a local family practice clinic. The clinic did full spectrum family practice, including prenatal care. The doctor saw between 25 and 35 patients each day plus covered urgent care during lunch. Paper charting was used although the clinic is looking into electronic records. The clinic was very efficient. All team members were very aware of their roles and did their jobs with a smile and worked well together.
“Most patient encounters took between 10 and 15 minutes although the patient might stay around for IV therapy, intramuscular pain medications, or other treatments that were carried out by the nursing staff. There was a small procedure room and procedures would be performed on the same day they were identified. The nursing staff would set up everything, and in between patients the provider would complete the procedure. On the first day I mostly shadowed, but in the afternoon, I was asked to consult on some of the more complicated patients with diabetes mellitus or hypertension. On the second day I shadowed a health care provider who did not speak English and through an interpreter he asked for my input. In the afternoon the nursing staff asked me to discuss the treatment of abscesses. I discussed techniques of incision and drainage and importance of packing and proper wound care, worked with one of their wound care nurses on packing of several wounds, and consulted on a patient with a venous stasis ulcer.
“We identified an educational opportunity for the nursing staff. On the third day I brought a US certified wound care specialist and I gave a Microsoft PowerPoint presentation on venous stasis ulcers and proper wound care. The nursing staff and clinic were very receptive and asked if we would develop a patient-based educational presentation. The wound care specialist spent the afternoon giving hands-on demonstrations in the wound care clinic, and I taught technique for excisional biopsy of skin tags and moles to physicians. One of the host physicians arranged for more consultations on more of the clinic’s complicated patients, which included a staff member and a relative.”
Medical Technician (MSgt, E-7, Independent Duty Medical Technician, USAF)
“The first day I was assigned to work with the ‘auxiliaries,’ nurses working in the urgent care area at the clinic. Their urgent care area had limited equipment and supplies and included equipment such as mercury thermometers, a few stethoscopes and 1 blood pressure cuff. Their duties consisted of screening patients, starting IVs, giving injections and breathing treatments. They also had a minor surgery room where the nurses helped.
“During the observation of the placement of an IV catheter, I noticed that they were using a port and attaching a needle to the IV tubing and leaving the needle attached to the patient. I asked them about their procedure and incidents with needlesticks since they had to be pretty accurate in getting the needle through the port. The nurse stated there were a significant number of cases of needlesticks. The following day, we brought 18-g, 20-g, and 23-g IV catheters, saline locks, syringes, and our team’s junior physician and I instructed the nurses how to set up an IV without using the needle port.
“The third day at the clinic, I assisted in checking in patients (blood pressure, weight, interviews). I also helped run the immunizations clinic, assisting in giving both pediatric and adult immunizations. Since there was only 1 nurse on shift that day, we multitasked and also gave injections prescribed by the providers, such as medroxyprogesterone and dexamethasone. By far, this was the most rewarding part of the mission. I really felt as though we were part of the team and believe we truly made a difference.”
Administrator (LTC, Medical Service Corps, USN)
“I learned many items from our visit to Clinica Dr. Francisco Quintanas Area de Salud 4 Chacarita. I reviewed the business plan contained in two 1.5-inch hardbound books. Their business plan outlined the population served, projections for upcoming year, and contracts. Area 4 served 21,344 people (11,197 men and 10,147 women). The business plan reviewed historical encounter information (ie, average patient is seen 2.6 times annually, 203,285 laboratory tests were performed in 2010, no radiology capabilities) and contained metrics for key programs for upcoming year (eg, vaccinations, women wellness) that seemed similar to US Healthcare Effectiveness Data and Information Set (HEDIS) measures.
“Our partners discussed financing of the health care they provide, including money flows to and from the government, the work center, and the employees. The business plan contains contract information and costs for maintenance, utilities, personnel, and other issues that would be typical for US-based operations as well. Housekeeping, some of the secretaries, and security staff are not employees—they are contracted personnel. Money is shifted to meet unexpected needs (ie, in 2009/2010–H1N1 influenza was unanticipated). Money was taken from other programs to meet the need.
“Within the Area 4 clinics there are 94 personnel, including 15 physicians. They have a document that is similar to our Activity Manning Document, which outlines personnel billet code, name, and specialty. The Asistentes Técnicos de Atención Primaria are the personnel who conduct home visits and are a unique capability—we do not have an exact equivalent in most US health care systems. Pregnant workers are released from work 1 month prior to the due date and are expected to return to work 3 months postdelivery.”
Medical Logistics (Capt, Medical Service Corps, USAF)
“Costa Rica is still growing in aspects of national health care but has a reliable system in place it seems. Similar to many of the countries visited, it has great capacity for building, but is challenged to increase its infrastructure. In 2011, part of this was due to a recent economic decline in the nation and its health care sector. They have interaction both with other regional clinics managed under the same national health system construct (Caja Costarricense del Seguro Social) as well as with private practices and specialty services. The clinics are open only daytime business hours. Only the regional hospital is open 24/7 for emergent care.
“Supplies are distributed to the regional clinics primarily from San José (the capital and largest city), but also there are some smaller warehousing of clinical materials located around the region. One of these warehouses was in Puntarenas where our clinic was located. To get better information for future supply chain management support we would need to speak with the central distribution/suppliers of all nationalized clinic-run entities. What our partners did teach is that at a higher, national level the clinics are standardized with what they will carry and need to keep on-hand depending upon the clinic classification (ie, level 1, 2, or 3).
“Equipment is purchased similar to the DoD method: Requests are submitted toward the end of the year, the administration prioritizes the lists, and then buys what they feel is most beneficial to the clinic with the resources available. Our hosts stated that before the end of the year, it is very difficult to prioritize needs other than some of the items that they ‘always need’ because they are unlikely to receive items very low on their list. The hosts stated that they would be very interested in having a chance to receive any excess US military equipment from their priority lists if there was a mechanism to do so. In future EHET missions, advance coordination would need to occur to see if (locally compatible) equipment needs could be met through the Defense Reutilization and Marketing Office (DRMO). Alternatively, an embedded team focused on Biomedical Equipment repair could work alongside partners such as at this clinic to develop a sustainable preventive maintenance and equipment testing program. Advance coordination on equipment status would foster improvement for resourceful partner clinics such as Chacarita, with targeted involvement from US military biomedical equipment technicians.”
Discussion
These 4 firsthand accounts from a multidisciplinary, primary-care focused, EHET offers multiple preliminary evidence of the value of this small-scale embedded approach. The accounts are responses to an open-ended prompt for personal impressions and key thoughts as part of an EHET. Three of the advantages gleaned from these accounts are greater personal satisfaction, detailed insight into local operations and health systems, and deeper empathy and respect for common challenges despite health system differences compared with the US military health system.
These advantages are critical to afford the US military personnel the ability to more effectively execute engagement goals, such as meeting health needs in humanitarian assistance, advancing interoperable capacity for security cooperation, or achieving targeted training to enhance US medical operational skills. The greater personal satisfaction was evident in the team member responses that, despite mission stops in 7 prior countries, “This by far was the most rewarding part of the Continuing Promise 2011 mission” and “I hope this becomes a tool used to augment humanitarian missions.”
The descriptions by both the administrator and the logistician on the intimate details that the hosts shared with them is a testament to the rapid trust engendered by the embedded approach. There was a trust to share information as a result of acknowledged local strengths and legitimate interest in local challenges. Peer appreciation was evident; although they did not speak the same literal language, they spoke the same professional language, which was apparent even through the use of an interpreter.
A third advantage, evident from these written exchanges is a regular acknowledgement that health system issues, pursued processes, and desired outcomes are similar between different systems. There may be significant differences in actual resources and infrastructure, but some of the bureaucracy is similar. This last insight is essential to grasp in order to seek capacity building and interoperable solutions toward common goals; empathy is needed to encourage local ownership and sustainability while respecting local challenges and different problem-solving approaches and processes.
Conclusions
The EHET concept afforded deep insight by team members into ways to partner with their hosts to target better health outcomes and meaningful partnership for potential long-term geopolitical impact. Long duration embedded teams, or recurrent insertion, in a single location will achieve greater long-term benefits because of greater health system and cultural understanding. EHETs, once accepted and refined from prototype to standard employment tool, should prove to be a more effective tool in building partnerships, building capacity, and increased security cooperation by using US military resources to support legitimate health needs either in a military-military or military-civilian setting.5 These firsthand accounts provide preliminary evidence that embedded teams may be a critical and needed tool to “ensure that military health engagement is appropriate, constructive, effective, and coordinated with other actors.”6
Acknowledgments
Additional original EHET team members included LCDR Jeanne Jimenez, RN; CDR Francine Worthington, Health Administrator; Maj Tony McClung, RN; Mrs. Romero, RN of LDS Charities, and the staff of the Chacarita clinics in Costa Rica.
1. US Department of Defense. Sustaining U.S. global leadership: priorities for 21st century defense. https://archive.defense.gov/news/Defense_Strategic_Guidance.pdf. Published January 2012. Accessed March 18, 2020.
2. Burkett EK. An embedded health engagement team pilot test, Mil Med. 2019;184(11-12):606-610.
3. Center for Disaster and Humanitarian Assistance Medicine. U.S. participants perspectives on military humanitarian assistance. https://www.hsdl.org/?view&did=446168. Accessed March 18, 2020.
4. Burkett EK. Embedded health engagement teams for improved health outcomes and foreign assistance, Poster presented at: AMSUS Annual Meeting November 30, 2015; San Antonio, TX. http://cdm16005.contentdm.oclc.org/cdm/singleitem/collection/p16005coll8/id/14. Accessed March 18, 2020.
5. Burkett EK, Ubiera J, Vess, J, Griffay T, Neese B, Lawrence C. Developing the prototype embedded health engagement team, Poster presented at: Military Health System Research Symposium, August 21, 2018; Orlando, FL. https://cdm16005.contentdm.oclc.org/digital/collection/p16005coll8/id/61/rec/1. Accessed March 18, 2020.
6. Michaud J, Moss K, Licina D, et al. Security and public health: the interface. Lancet. 2019;393(10168):P276-P286. http://glham.org/wp-content/uploads/Militaries-and-Global-Health-Lancet-Series.pdf. Accessed March 18, 2020.
“Whenever possible, we will develop innovative, low-cost, and small-footprint approaches to achieve our security objectives.” 1
Team member and participant observations can deliver valuable insight into the effectiveness of an activity or project. Certainly, documentation of such qualitative assessment through survey questions or narratives can reveal important information for future action. This qualitative aspect was a significant consideration in the formation of an embedded health engagement team (EHET) intended to improve foreign assistance and health outcomes for global humanitarian and security cooperation activities.
Since health activities are centered on human interaction and relationships, some observation or qualitative assessment must be included to truly determine short-term local buy-in and long-term outcomes. The following observations include the direct narrative perspectives of team members from a multidisciplinary primary care EHET that add experiential depth to prior assessment of the pilot test of such teams during Continuing Promise 2011, a 9-country series of health engagement activities employed from the USNS Comfort.2 The embedded team consisted of US Air Force (USAF), US Navy (USN), and nongovernmental organization (NGO) personnel working directly in a primary care clinic of the Costa Rican public health system.
This is small sample of a few team members who responded to a simple, open-ended prompt to record their impression of the EHET concept and experiences. Documenting this information should highlight the importance of seeking similar qualitative mission data for future health engagements. Standardized questionnaires have been used to evaluate health activities and have provided valuable analysis and recommendations that have advanced US Department of Defense (DoD) global health engagement.3 Captured narrative observation from the EHET pilot study is a complementary qualitative method that supports the concept of small, well prepared, culturally competent, EHETs tailored to work within a partner system rather than outside of it will achieve greater mutual benefit, including the application of better, more equitable health and health system principles.4 In this embedded manner, health care professionals may readily contribute to host nation health sector plans and goals while achieving military objectives, political goals, and mutual strategic interests through both military-military and military-civilian applications.
Observations and Reflections
Family Physician (Maj, Second Physician, USAF)
“Overall, the experience I had with the embedded team was truly rewarding. I hope this becomes a tool used to augment humanitarian missions. There is no way to truly understand a systems strengths and weakness except by being embedded in the clinic or hospital. For 3 days I worked alongside a bilingual physician at a local family practice clinic. The clinic did full spectrum family practice, including prenatal care. The doctor saw between 25 and 35 patients each day plus covered urgent care during lunch. Paper charting was used although the clinic is looking into electronic records. The clinic was very efficient. All team members were very aware of their roles and did their jobs with a smile and worked well together.
“Most patient encounters took between 10 and 15 minutes although the patient might stay around for IV therapy, intramuscular pain medications, or other treatments that were carried out by the nursing staff. There was a small procedure room and procedures would be performed on the same day they were identified. The nursing staff would set up everything, and in between patients the provider would complete the procedure. On the first day I mostly shadowed, but in the afternoon, I was asked to consult on some of the more complicated patients with diabetes mellitus or hypertension. On the second day I shadowed a health care provider who did not speak English and through an interpreter he asked for my input. In the afternoon the nursing staff asked me to discuss the treatment of abscesses. I discussed techniques of incision and drainage and importance of packing and proper wound care, worked with one of their wound care nurses on packing of several wounds, and consulted on a patient with a venous stasis ulcer.
“We identified an educational opportunity for the nursing staff. On the third day I brought a US certified wound care specialist and I gave a Microsoft PowerPoint presentation on venous stasis ulcers and proper wound care. The nursing staff and clinic were very receptive and asked if we would develop a patient-based educational presentation. The wound care specialist spent the afternoon giving hands-on demonstrations in the wound care clinic, and I taught technique for excisional biopsy of skin tags and moles to physicians. One of the host physicians arranged for more consultations on more of the clinic’s complicated patients, which included a staff member and a relative.”
Medical Technician (MSgt, E-7, Independent Duty Medical Technician, USAF)
“The first day I was assigned to work with the ‘auxiliaries,’ nurses working in the urgent care area at the clinic. Their urgent care area had limited equipment and supplies and included equipment such as mercury thermometers, a few stethoscopes and 1 blood pressure cuff. Their duties consisted of screening patients, starting IVs, giving injections and breathing treatments. They also had a minor surgery room where the nurses helped.
“During the observation of the placement of an IV catheter, I noticed that they were using a port and attaching a needle to the IV tubing and leaving the needle attached to the patient. I asked them about their procedure and incidents with needlesticks since they had to be pretty accurate in getting the needle through the port. The nurse stated there were a significant number of cases of needlesticks. The following day, we brought 18-g, 20-g, and 23-g IV catheters, saline locks, syringes, and our team’s junior physician and I instructed the nurses how to set up an IV without using the needle port.
“The third day at the clinic, I assisted in checking in patients (blood pressure, weight, interviews). I also helped run the immunizations clinic, assisting in giving both pediatric and adult immunizations. Since there was only 1 nurse on shift that day, we multitasked and also gave injections prescribed by the providers, such as medroxyprogesterone and dexamethasone. By far, this was the most rewarding part of the mission. I really felt as though we were part of the team and believe we truly made a difference.”
Administrator (LTC, Medical Service Corps, USN)
“I learned many items from our visit to Clinica Dr. Francisco Quintanas Area de Salud 4 Chacarita. I reviewed the business plan contained in two 1.5-inch hardbound books. Their business plan outlined the population served, projections for upcoming year, and contracts. Area 4 served 21,344 people (11,197 men and 10,147 women). The business plan reviewed historical encounter information (ie, average patient is seen 2.6 times annually, 203,285 laboratory tests were performed in 2010, no radiology capabilities) and contained metrics for key programs for upcoming year (eg, vaccinations, women wellness) that seemed similar to US Healthcare Effectiveness Data and Information Set (HEDIS) measures.
“Our partners discussed financing of the health care they provide, including money flows to and from the government, the work center, and the employees. The business plan contains contract information and costs for maintenance, utilities, personnel, and other issues that would be typical for US-based operations as well. Housekeeping, some of the secretaries, and security staff are not employees—they are contracted personnel. Money is shifted to meet unexpected needs (ie, in 2009/2010–H1N1 influenza was unanticipated). Money was taken from other programs to meet the need.
“Within the Area 4 clinics there are 94 personnel, including 15 physicians. They have a document that is similar to our Activity Manning Document, which outlines personnel billet code, name, and specialty. The Asistentes Técnicos de Atención Primaria are the personnel who conduct home visits and are a unique capability—we do not have an exact equivalent in most US health care systems. Pregnant workers are released from work 1 month prior to the due date and are expected to return to work 3 months postdelivery.”
Medical Logistics (Capt, Medical Service Corps, USAF)
“Costa Rica is still growing in aspects of national health care but has a reliable system in place it seems. Similar to many of the countries visited, it has great capacity for building, but is challenged to increase its infrastructure. In 2011, part of this was due to a recent economic decline in the nation and its health care sector. They have interaction both with other regional clinics managed under the same national health system construct (Caja Costarricense del Seguro Social) as well as with private practices and specialty services. The clinics are open only daytime business hours. Only the regional hospital is open 24/7 for emergent care.
“Supplies are distributed to the regional clinics primarily from San José (the capital and largest city), but also there are some smaller warehousing of clinical materials located around the region. One of these warehouses was in Puntarenas where our clinic was located. To get better information for future supply chain management support we would need to speak with the central distribution/suppliers of all nationalized clinic-run entities. What our partners did teach is that at a higher, national level the clinics are standardized with what they will carry and need to keep on-hand depending upon the clinic classification (ie, level 1, 2, or 3).
“Equipment is purchased similar to the DoD method: Requests are submitted toward the end of the year, the administration prioritizes the lists, and then buys what they feel is most beneficial to the clinic with the resources available. Our hosts stated that before the end of the year, it is very difficult to prioritize needs other than some of the items that they ‘always need’ because they are unlikely to receive items very low on their list. The hosts stated that they would be very interested in having a chance to receive any excess US military equipment from their priority lists if there was a mechanism to do so. In future EHET missions, advance coordination would need to occur to see if (locally compatible) equipment needs could be met through the Defense Reutilization and Marketing Office (DRMO). Alternatively, an embedded team focused on Biomedical Equipment repair could work alongside partners such as at this clinic to develop a sustainable preventive maintenance and equipment testing program. Advance coordination on equipment status would foster improvement for resourceful partner clinics such as Chacarita, with targeted involvement from US military biomedical equipment technicians.”
Discussion
These 4 firsthand accounts from a multidisciplinary, primary-care focused, EHET offers multiple preliminary evidence of the value of this small-scale embedded approach. The accounts are responses to an open-ended prompt for personal impressions and key thoughts as part of an EHET. Three of the advantages gleaned from these accounts are greater personal satisfaction, detailed insight into local operations and health systems, and deeper empathy and respect for common challenges despite health system differences compared with the US military health system.
These advantages are critical to afford the US military personnel the ability to more effectively execute engagement goals, such as meeting health needs in humanitarian assistance, advancing interoperable capacity for security cooperation, or achieving targeted training to enhance US medical operational skills. The greater personal satisfaction was evident in the team member responses that, despite mission stops in 7 prior countries, “This by far was the most rewarding part of the Continuing Promise 2011 mission” and “I hope this becomes a tool used to augment humanitarian missions.”
The descriptions by both the administrator and the logistician on the intimate details that the hosts shared with them is a testament to the rapid trust engendered by the embedded approach. There was a trust to share information as a result of acknowledged local strengths and legitimate interest in local challenges. Peer appreciation was evident; although they did not speak the same literal language, they spoke the same professional language, which was apparent even through the use of an interpreter.
A third advantage, evident from these written exchanges is a regular acknowledgement that health system issues, pursued processes, and desired outcomes are similar between different systems. There may be significant differences in actual resources and infrastructure, but some of the bureaucracy is similar. This last insight is essential to grasp in order to seek capacity building and interoperable solutions toward common goals; empathy is needed to encourage local ownership and sustainability while respecting local challenges and different problem-solving approaches and processes.
Conclusions
The EHET concept afforded deep insight by team members into ways to partner with their hosts to target better health outcomes and meaningful partnership for potential long-term geopolitical impact. Long duration embedded teams, or recurrent insertion, in a single location will achieve greater long-term benefits because of greater health system and cultural understanding. EHETs, once accepted and refined from prototype to standard employment tool, should prove to be a more effective tool in building partnerships, building capacity, and increased security cooperation by using US military resources to support legitimate health needs either in a military-military or military-civilian setting.5 These firsthand accounts provide preliminary evidence that embedded teams may be a critical and needed tool to “ensure that military health engagement is appropriate, constructive, effective, and coordinated with other actors.”6
Acknowledgments
Additional original EHET team members included LCDR Jeanne Jimenez, RN; CDR Francine Worthington, Health Administrator; Maj Tony McClung, RN; Mrs. Romero, RN of LDS Charities, and the staff of the Chacarita clinics in Costa Rica.
“Whenever possible, we will develop innovative, low-cost, and small-footprint approaches to achieve our security objectives.” 1
Team member and participant observations can deliver valuable insight into the effectiveness of an activity or project. Certainly, documentation of such qualitative assessment through survey questions or narratives can reveal important information for future action. This qualitative aspect was a significant consideration in the formation of an embedded health engagement team (EHET) intended to improve foreign assistance and health outcomes for global humanitarian and security cooperation activities.
Since health activities are centered on human interaction and relationships, some observation or qualitative assessment must be included to truly determine short-term local buy-in and long-term outcomes. The following observations include the direct narrative perspectives of team members from a multidisciplinary primary care EHET that add experiential depth to prior assessment of the pilot test of such teams during Continuing Promise 2011, a 9-country series of health engagement activities employed from the USNS Comfort.2 The embedded team consisted of US Air Force (USAF), US Navy (USN), and nongovernmental organization (NGO) personnel working directly in a primary care clinic of the Costa Rican public health system.
This is small sample of a few team members who responded to a simple, open-ended prompt to record their impression of the EHET concept and experiences. Documenting this information should highlight the importance of seeking similar qualitative mission data for future health engagements. Standardized questionnaires have been used to evaluate health activities and have provided valuable analysis and recommendations that have advanced US Department of Defense (DoD) global health engagement.3 Captured narrative observation from the EHET pilot study is a complementary qualitative method that supports the concept of small, well prepared, culturally competent, EHETs tailored to work within a partner system rather than outside of it will achieve greater mutual benefit, including the application of better, more equitable health and health system principles.4 In this embedded manner, health care professionals may readily contribute to host nation health sector plans and goals while achieving military objectives, political goals, and mutual strategic interests through both military-military and military-civilian applications.
Observations and Reflections
Family Physician (Maj, Second Physician, USAF)
“Overall, the experience I had with the embedded team was truly rewarding. I hope this becomes a tool used to augment humanitarian missions. There is no way to truly understand a systems strengths and weakness except by being embedded in the clinic or hospital. For 3 days I worked alongside a bilingual physician at a local family practice clinic. The clinic did full spectrum family practice, including prenatal care. The doctor saw between 25 and 35 patients each day plus covered urgent care during lunch. Paper charting was used although the clinic is looking into electronic records. The clinic was very efficient. All team members were very aware of their roles and did their jobs with a smile and worked well together.
“Most patient encounters took between 10 and 15 minutes although the patient might stay around for IV therapy, intramuscular pain medications, or other treatments that were carried out by the nursing staff. There was a small procedure room and procedures would be performed on the same day they were identified. The nursing staff would set up everything, and in between patients the provider would complete the procedure. On the first day I mostly shadowed, but in the afternoon, I was asked to consult on some of the more complicated patients with diabetes mellitus or hypertension. On the second day I shadowed a health care provider who did not speak English and through an interpreter he asked for my input. In the afternoon the nursing staff asked me to discuss the treatment of abscesses. I discussed techniques of incision and drainage and importance of packing and proper wound care, worked with one of their wound care nurses on packing of several wounds, and consulted on a patient with a venous stasis ulcer.
“We identified an educational opportunity for the nursing staff. On the third day I brought a US certified wound care specialist and I gave a Microsoft PowerPoint presentation on venous stasis ulcers and proper wound care. The nursing staff and clinic were very receptive and asked if we would develop a patient-based educational presentation. The wound care specialist spent the afternoon giving hands-on demonstrations in the wound care clinic, and I taught technique for excisional biopsy of skin tags and moles to physicians. One of the host physicians arranged for more consultations on more of the clinic’s complicated patients, which included a staff member and a relative.”
Medical Technician (MSgt, E-7, Independent Duty Medical Technician, USAF)
“The first day I was assigned to work with the ‘auxiliaries,’ nurses working in the urgent care area at the clinic. Their urgent care area had limited equipment and supplies and included equipment such as mercury thermometers, a few stethoscopes and 1 blood pressure cuff. Their duties consisted of screening patients, starting IVs, giving injections and breathing treatments. They also had a minor surgery room where the nurses helped.
“During the observation of the placement of an IV catheter, I noticed that they were using a port and attaching a needle to the IV tubing and leaving the needle attached to the patient. I asked them about their procedure and incidents with needlesticks since they had to be pretty accurate in getting the needle through the port. The nurse stated there were a significant number of cases of needlesticks. The following day, we brought 18-g, 20-g, and 23-g IV catheters, saline locks, syringes, and our team’s junior physician and I instructed the nurses how to set up an IV without using the needle port.
“The third day at the clinic, I assisted in checking in patients (blood pressure, weight, interviews). I also helped run the immunizations clinic, assisting in giving both pediatric and adult immunizations. Since there was only 1 nurse on shift that day, we multitasked and also gave injections prescribed by the providers, such as medroxyprogesterone and dexamethasone. By far, this was the most rewarding part of the mission. I really felt as though we were part of the team and believe we truly made a difference.”
Administrator (LTC, Medical Service Corps, USN)
“I learned many items from our visit to Clinica Dr. Francisco Quintanas Area de Salud 4 Chacarita. I reviewed the business plan contained in two 1.5-inch hardbound books. Their business plan outlined the population served, projections for upcoming year, and contracts. Area 4 served 21,344 people (11,197 men and 10,147 women). The business plan reviewed historical encounter information (ie, average patient is seen 2.6 times annually, 203,285 laboratory tests were performed in 2010, no radiology capabilities) and contained metrics for key programs for upcoming year (eg, vaccinations, women wellness) that seemed similar to US Healthcare Effectiveness Data and Information Set (HEDIS) measures.
“Our partners discussed financing of the health care they provide, including money flows to and from the government, the work center, and the employees. The business plan contains contract information and costs for maintenance, utilities, personnel, and other issues that would be typical for US-based operations as well. Housekeeping, some of the secretaries, and security staff are not employees—they are contracted personnel. Money is shifted to meet unexpected needs (ie, in 2009/2010–H1N1 influenza was unanticipated). Money was taken from other programs to meet the need.
“Within the Area 4 clinics there are 94 personnel, including 15 physicians. They have a document that is similar to our Activity Manning Document, which outlines personnel billet code, name, and specialty. The Asistentes Técnicos de Atención Primaria are the personnel who conduct home visits and are a unique capability—we do not have an exact equivalent in most US health care systems. Pregnant workers are released from work 1 month prior to the due date and are expected to return to work 3 months postdelivery.”
Medical Logistics (Capt, Medical Service Corps, USAF)
“Costa Rica is still growing in aspects of national health care but has a reliable system in place it seems. Similar to many of the countries visited, it has great capacity for building, but is challenged to increase its infrastructure. In 2011, part of this was due to a recent economic decline in the nation and its health care sector. They have interaction both with other regional clinics managed under the same national health system construct (Caja Costarricense del Seguro Social) as well as with private practices and specialty services. The clinics are open only daytime business hours. Only the regional hospital is open 24/7 for emergent care.
“Supplies are distributed to the regional clinics primarily from San José (the capital and largest city), but also there are some smaller warehousing of clinical materials located around the region. One of these warehouses was in Puntarenas where our clinic was located. To get better information for future supply chain management support we would need to speak with the central distribution/suppliers of all nationalized clinic-run entities. What our partners did teach is that at a higher, national level the clinics are standardized with what they will carry and need to keep on-hand depending upon the clinic classification (ie, level 1, 2, or 3).
“Equipment is purchased similar to the DoD method: Requests are submitted toward the end of the year, the administration prioritizes the lists, and then buys what they feel is most beneficial to the clinic with the resources available. Our hosts stated that before the end of the year, it is very difficult to prioritize needs other than some of the items that they ‘always need’ because they are unlikely to receive items very low on their list. The hosts stated that they would be very interested in having a chance to receive any excess US military equipment from their priority lists if there was a mechanism to do so. In future EHET missions, advance coordination would need to occur to see if (locally compatible) equipment needs could be met through the Defense Reutilization and Marketing Office (DRMO). Alternatively, an embedded team focused on Biomedical Equipment repair could work alongside partners such as at this clinic to develop a sustainable preventive maintenance and equipment testing program. Advance coordination on equipment status would foster improvement for resourceful partner clinics such as Chacarita, with targeted involvement from US military biomedical equipment technicians.”
Discussion
These 4 firsthand accounts from a multidisciplinary, primary-care focused, EHET offers multiple preliminary evidence of the value of this small-scale embedded approach. The accounts are responses to an open-ended prompt for personal impressions and key thoughts as part of an EHET. Three of the advantages gleaned from these accounts are greater personal satisfaction, detailed insight into local operations and health systems, and deeper empathy and respect for common challenges despite health system differences compared with the US military health system.
These advantages are critical to afford the US military personnel the ability to more effectively execute engagement goals, such as meeting health needs in humanitarian assistance, advancing interoperable capacity for security cooperation, or achieving targeted training to enhance US medical operational skills. The greater personal satisfaction was evident in the team member responses that, despite mission stops in 7 prior countries, “This by far was the most rewarding part of the Continuing Promise 2011 mission” and “I hope this becomes a tool used to augment humanitarian missions.”
The descriptions by both the administrator and the logistician on the intimate details that the hosts shared with them is a testament to the rapid trust engendered by the embedded approach. There was a trust to share information as a result of acknowledged local strengths and legitimate interest in local challenges. Peer appreciation was evident; although they did not speak the same literal language, they spoke the same professional language, which was apparent even through the use of an interpreter.
A third advantage, evident from these written exchanges is a regular acknowledgement that health system issues, pursued processes, and desired outcomes are similar between different systems. There may be significant differences in actual resources and infrastructure, but some of the bureaucracy is similar. This last insight is essential to grasp in order to seek capacity building and interoperable solutions toward common goals; empathy is needed to encourage local ownership and sustainability while respecting local challenges and different problem-solving approaches and processes.
Conclusions
The EHET concept afforded deep insight by team members into ways to partner with their hosts to target better health outcomes and meaningful partnership for potential long-term geopolitical impact. Long duration embedded teams, or recurrent insertion, in a single location will achieve greater long-term benefits because of greater health system and cultural understanding. EHETs, once accepted and refined from prototype to standard employment tool, should prove to be a more effective tool in building partnerships, building capacity, and increased security cooperation by using US military resources to support legitimate health needs either in a military-military or military-civilian setting.5 These firsthand accounts provide preliminary evidence that embedded teams may be a critical and needed tool to “ensure that military health engagement is appropriate, constructive, effective, and coordinated with other actors.”6
Acknowledgments
Additional original EHET team members included LCDR Jeanne Jimenez, RN; CDR Francine Worthington, Health Administrator; Maj Tony McClung, RN; Mrs. Romero, RN of LDS Charities, and the staff of the Chacarita clinics in Costa Rica.
1. US Department of Defense. Sustaining U.S. global leadership: priorities for 21st century defense. https://archive.defense.gov/news/Defense_Strategic_Guidance.pdf. Published January 2012. Accessed March 18, 2020.
2. Burkett EK. An embedded health engagement team pilot test, Mil Med. 2019;184(11-12):606-610.
3. Center for Disaster and Humanitarian Assistance Medicine. U.S. participants perspectives on military humanitarian assistance. https://www.hsdl.org/?view&did=446168. Accessed March 18, 2020.
4. Burkett EK. Embedded health engagement teams for improved health outcomes and foreign assistance, Poster presented at: AMSUS Annual Meeting November 30, 2015; San Antonio, TX. http://cdm16005.contentdm.oclc.org/cdm/singleitem/collection/p16005coll8/id/14. Accessed March 18, 2020.
5. Burkett EK, Ubiera J, Vess, J, Griffay T, Neese B, Lawrence C. Developing the prototype embedded health engagement team, Poster presented at: Military Health System Research Symposium, August 21, 2018; Orlando, FL. https://cdm16005.contentdm.oclc.org/digital/collection/p16005coll8/id/61/rec/1. Accessed March 18, 2020.
6. Michaud J, Moss K, Licina D, et al. Security and public health: the interface. Lancet. 2019;393(10168):P276-P286. http://glham.org/wp-content/uploads/Militaries-and-Global-Health-Lancet-Series.pdf. Accessed March 18, 2020.
1. US Department of Defense. Sustaining U.S. global leadership: priorities for 21st century defense. https://archive.defense.gov/news/Defense_Strategic_Guidance.pdf. Published January 2012. Accessed March 18, 2020.
2. Burkett EK. An embedded health engagement team pilot test, Mil Med. 2019;184(11-12):606-610.
3. Center for Disaster and Humanitarian Assistance Medicine. U.S. participants perspectives on military humanitarian assistance. https://www.hsdl.org/?view&did=446168. Accessed March 18, 2020.
4. Burkett EK. Embedded health engagement teams for improved health outcomes and foreign assistance, Poster presented at: AMSUS Annual Meeting November 30, 2015; San Antonio, TX. http://cdm16005.contentdm.oclc.org/cdm/singleitem/collection/p16005coll8/id/14. Accessed March 18, 2020.
5. Burkett EK, Ubiera J, Vess, J, Griffay T, Neese B, Lawrence C. Developing the prototype embedded health engagement team, Poster presented at: Military Health System Research Symposium, August 21, 2018; Orlando, FL. https://cdm16005.contentdm.oclc.org/digital/collection/p16005coll8/id/61/rec/1. Accessed March 18, 2020.
6. Michaud J, Moss K, Licina D, et al. Security and public health: the interface. Lancet. 2019;393(10168):P276-P286. http://glham.org/wp-content/uploads/Militaries-and-Global-Health-Lancet-Series.pdf. Accessed March 18, 2020.
An Interdisciplinary Clinic for Former Prisoners of War
Since the beginning of the American Republic, servicemen have been captured and held as prisoners of war (POWs), including > 130,000 in World War II , > 7,100 in the Korean War, > 700 in the Vietnam War, and 37 in Operation Desert Storm and recent conflicts.1,2 Also, > 80 servicewomen have been held during these conflicts.1-3 Of those living former POWs (FPOWs), almost all are geriatric (aged > 65 years) with a significant portion aged ≥ 85 years.
The physical hardships and psychological stress endured by FPOWs have lifelong deleterious sequelae on health and social functioning.3-5 The experiences of FPOWs are associated with higher prevalence of chronic diseases and diminished functional performance in later life as demonstrated by a survey of FPOWs from World War II.4 The survey assessed health and functional status in a random sample of 101 FPOWs and a group of 107 non-POW combatants from the same military operations. FPOWs reported a higher mean number of somatic symptoms than did non-POWs (7.2 vs 5.4, respectively; P = .002), a higher mean number of diagnosed health conditions (9.4 vs 7.7, respectively; P < .001), and used a greater mean number of medications (4.5 vs 3.4, respectively; P = .001). Among 15 broad categories of diagnoses, differences were found in gastrointestinal disorders (FPOWs 63% vs non-POWs 49%, P = .032), musculoskeletal disorders (FPOWs 76% vs non-POWs 60%, P = .001), and cognitive disorders (FPOWs 31% vs non-POWs 15%, P = .006). FPOWs had a significantly higher proportion of 7 extrapyramidal signs and 6 signs relating to ataxia. On the Instrumental Activities of Daily Living scale, FPOWs were more likely to be impaired than were non-POWs (33% vs 17%, respectively; P = .01). In addition, FPOWs have an increased risk of developing dementia, and this risk is doubled in FPOWs with posttraumatic stress disorder (PTSD) compared with non-FPOWs without PTSD.5
These data indicate that FPOW status is associated with increased risk of disability and loss of independence. Federal statutes established the presumption of a relationship between FPOW status and many comorbidities for VA disability determinations in recognition of such data and to overcome lack of medical records during POW confinement and to accord benefit of the doubt where medical science cannot conclusively link disease etiology to FPOW status, to FPOWs.
Service-Connected Conditions
The historical development of conditions with a presumption of service connection for adjudication of VA compensation/disability claims began in 1921 with the Act to Establish a Veterans’ Bureau and to Improve the Facilities.1 The act simplified and streamlined the claims adjudication process by eliminating the need to obtain evidence on the part of the veteran. The presumption of service connection also facilitated increased accuracy and consistency in adjudications by requiring similar treatment for similar claims. This “presumptive” process relieved claimants and VA of the necessity of producing direct evidence when it was impractical to do so.
In 1970, the first presumptives specific to FPOWs were legislatively established and covered 17 diseases for a FPOW who had been confined for ≥ 30 days (Pub. L. 91-376). The 30-day confinement requirement was later relaxed, and additional presumptives were established that related to diseases that were more common among FPOWs than they were among non-FPOWs. These disorders included traumatic arthritis, stroke, heart disease, osteoporosis, peripheral neuropathy, cold injuries, as well as a variety of digestive and neuropsychiatric disorders. If a FPOW is diagnosed as having ≥ 1 of these conditions and it is judged to be ≥ 10% disabling, the condition is presumed to be a sequelae of the POW experience, and it is classified as a service-connected disability (Table).
FPOW Care And Benefits Teams
Several Veterans Health Administration (VHA) directives have been issued, including the recent VHA directive 1650, which requires that each VHA medical facility have a special Care and Benefits Team (CBT) that is charged with the evaluation and treatment of FPOWs to ensure that “FPOWs receive the highest quality care and benefit services.”6 CBTs must be composed of a clinician trained in internal medicine or family practice; a clinician who is certified through the VA Office of Disability and Medical Assessment to conduct General Medical Compensation and Pension evaluations; a FPOW advocate who typically is a VHA clinical social worker; and a Veterans Benefits Administration (VBA) FPOW coordinator appointed by the local VBA regional office. CBTs can be expanded to include other members as needed. The CBTs are tasked with facilitating interactions between FPOWs, the VHA, and the VBA.
CBTs face several challenges in meeting their responsibilities. For example, the POW experience often results in psychological trauma that foments denial and distrust; hence, thoughtful sensitivity to the sequelae of captivity when approaching FPOWs about personal issues, such as health care, is required. Establishing trusting relationships with FPOWs is necessary if their needs are to be effectively addressed.
While the VHA is mandated to provide priority treatment for FPOWs, including hospital, nursing home, dental, and outpatient treatment, a significant number of FPOWs do not avail themselves of benefits to which they are entitled. Often these FPOWs have not used VA programs and facilities because they are uninformed or confused about VA benefits for FPOWs. As a result, referrals of eligible FPOWs to appropriate programs can be overlooked. Maximizing the service-connected disability rating of FPOWs not only impacts the disability pensions received by these veterans, but also impacts their eligibility for VHA programs, including long-term care and Dependency and Indemnity Compensation, a monthly benefit paid to spouses, children, and/or surviving parents.
In 2013, the FPOW Committee of the South Texas Veterans Health Care System (STVHCS) noted that 40% of FPOWs in our region had no VA primary care or clinic assignment. In consideration of the commitment of the VA to care for FPOWs, the unique POW-related medical and psychological issues, the geriatric age of many FPOWs, and the surprising number of FPOWs currently not receiving VA care, we expanded the concept of the CBT team to create a specialized interdisciplinary FPOW Clinic to address the unique needs of this predominantly elderly population and to involve more FPOWs in the VA system.
The main purpose of this clinic was to advise FPOWs of all VA benefits and services to which they may be entitled by identifying overlooked FPOW presumptives. As the number of FPOWs continues to decrease, outreach to FPOWs and family members has become critical, especially as increased benefits and special services might be available to this increasingly dependent older population. An informal survey of FPOW advocates across the nation found that 21% of FPOWs had disability ratings from the VA of ≤ 60%, including some who had no VA disability rating at all. Thus, an additional goal of the project was to develop a clinic model that could be disseminated throughout the VHA.
Design
The design of the FPOW Clinic team is based on an interdisciplinary model that has proven successful in geriatric medicine.7 The team comprises a physician, a social worker, and a registered nurse.8 All members have expertise in geriatric medicine and specific training in FPOW-related issues by completing a VA employee education training session on FPOW case management. Completion of this training ensured that team members were:
- Familiar with the experiences of FPOWs as well as about the medical, psychosocial, and mental health conditions that affect FPOWs;
- Knowledgeable about FPOW presumptive conditions;
- Familiar with the VBA process for rating FPOW disability claims; and
- Capable of FPOW case coordination, workflow, and communications between the FPOW Clinic team and the VBA to avail FPOWs and their families of all eligible benefits.
In-person FPOW clinic visits and chart reviews helped identify overlooked FPOW benefits. To facilitate case management, a representative of the VBA attended the initial evaluation of each FPOW in the clinic to confirm any overlooked presumptive benefits and to familiarize FPOWs with the claims process. FPOWs were also given the choice to officially enroll in the FPOW clinic for primary care or to remain with their current health care provider. Special efforts were made to enroll those FPOWs who had no STVHCS assigned primary care clinic.
The clinic was scheduled for 4 hours every week. Initial patient visits were 2 hours each and consisted of separate evaluations by each of the 3 FPOW Clinic team members who then met as a team with the addition of the VBA representative. The purpose of this meeting was to discuss overlooked benefits, address any other specific issues noted, and to devise an appropriate interdisciplinary plan. Findings of overlooked benefits and other relevant outcomes then were conveyed to the FPOW. For FPOWs who opted to continue in the clinic for their primary care, subsequent appointments were 1 hour.
Implementation
STVHCS FPOW advocates identified and sent letters to FPOWs announcing the opening of the clinic and its goals. Phone calls were made to each FPOW to address questions and to ascertain their interest. The FPOW advocates then worked directly with schedulers to make clinic appointments. Forty-one FPOWs responded to this initial invitation and attended the new clinic. Subsequently, this number increased through FPOW consults placed by STVHCS primary care providers.
The service-connected disability rating of clinic patients ranged from none (6% of attendees) to 100% (28% of attendees). For 34% of patients, clinic attendance resulted in identification application for overlooked presumptives. VBA evaluation resulted in increased service-connected disability ratings for nearly one-third of clinic patients. All clinic patients without a service-connected disability prior to FPOW clinic evaluation received an increased service-connected disability rating. Overall, 60% of the FPOWs who attended the clinic opted to receive their primary care at the FPOW clinic.
The FPOW Clinic successfully identified overlooked presumptives and facilitated the determination of appropriate service-connected disabilities. Interestingly, the FPOW Clinic encountered an unanticipated challenge to identifying overlooked FPOW benefits—veterans’ medical conditions that are listed by the VHA as being service-connected in the Computerized Patient Record System did not always reflect those listed officially in VBA records. This led to occasional identification of apparently overlooked FPOW presumptives that were already recognized by the VBA but not reflected in VHA records. This issue was addressed by ensuring that VBA representatives attended postclinic meetings with clinic staff and avoided the need to pursue supposedly unrecognized benefits that were recognized.
Telehealth
At present, FPOWs from World War II outnumber those of all other conflicts; however, this group is rapidly dwindling in numbers. World War II FPOWs are aged > 85 years, and therefore among the most frail and dependent of veterans. Often they are homebound and unable to physically travel to clinics for assessment. To serve these veterans, we are modifying the FPOW Clinic to utilize telehealth. The Telehealth FPOW Clinic will obtain relevant data from review of the electronic health record and telehealth-based clinic visits. Telehealth also may be used for assessments of Vietnam War veterans (eg, Agent Orange exposure), atomic veterans, and Gulf War veterans. Once fully designed and implemented, we believe that telehealth will prove to be a cost-effective way to provide clinic benefits to rural and older veterans.
Conclusions
The VHA provides priority medical treatment to FPOWs as well as timely and appropriate assessment of their eligibility for veterans’ benefits. The complexities benefit programs established for FPOWs is often beyond the ken of VHA physicians, social workers, and nurses. Because of this unfamiliarity, referrals of eligible FPOWs to appropriate programs can be overlooked. We established a clinic-based interdisciplinary team (FPOW Clinic) that was fully trained in FPOW benefit programs to identify overlooked benefits for FPOWs and were able to increase the disability rating on approximately one-third of the FPOWs seen in the FPOW Clinic. A telehealth-based version of the FPOW clinic is now being developed.
1. Henning CA; Congressional Research Service. POWs and MIAs: status and accounting issues. https://fas.org/sgp/crs/natsec/RL33452.pdf. Published June 1, 2006. Accessed March 16, 2020.
2. Klein RE, Wells MR, Somers JM. American Prisoners of War (POWs) and Missing in Action (MIAs). Washington, DC: US Department of Veterans Affairs, Office of Policy, Planning, and Preparedness; 2006.
3. Skelton WP 3rd. American ex-prisoners of war. https://m.vfwilserviceoffice.com/upload/VA%20Report%20on%20Former%20POWs.pdf. Updated April 2002. Accessed March 16, 2020.
4. Creasey H, Sulway MR, Dent O, Broe GA, Jorm A, Tennant C. Is experience as a prisoner of war a risk factor for accelerated age-related illness and disability? J Am Geriatr Soc. 1999;47(1):60-64.
5. Meziab O, Kirby KA, Williams B, Yaffe K, Byers AL, Barnes DE. Prisoner of war status, posttraumatic stress disorder, and dementia in older veterans. Alzheimers Dement. 2014;10(3)(suppl):S236-S241.
6. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1650. Special Care and Benefits Teams Evaluating or Treating Former Prisoners of War. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7481. Published July 31, 2018. Accessed March 16, 2020.
7. Boult C, Boult LB, Morishita L, Dowd B, Kane RL, Urdangarin CF. A randomized clinical trial of outpatient geriatric evaluation and management. J Am Geriatr Soc. 2001;49(4):351-359.
8. Kellogg, DL Jr. Geriatric Research, Education and Clinical Center (GRECC): former prisoners of war (FPOW) clinic, methods, procedures & training manual. https://www.southtexas.va.gov/grecc/docs/FPOW_toolkit.pdf. Updated January 28, 2015. Accessed March 16, 2020.
Since the beginning of the American Republic, servicemen have been captured and held as prisoners of war (POWs), including > 130,000 in World War II , > 7,100 in the Korean War, > 700 in the Vietnam War, and 37 in Operation Desert Storm and recent conflicts.1,2 Also, > 80 servicewomen have been held during these conflicts.1-3 Of those living former POWs (FPOWs), almost all are geriatric (aged > 65 years) with a significant portion aged ≥ 85 years.
The physical hardships and psychological stress endured by FPOWs have lifelong deleterious sequelae on health and social functioning.3-5 The experiences of FPOWs are associated with higher prevalence of chronic diseases and diminished functional performance in later life as demonstrated by a survey of FPOWs from World War II.4 The survey assessed health and functional status in a random sample of 101 FPOWs and a group of 107 non-POW combatants from the same military operations. FPOWs reported a higher mean number of somatic symptoms than did non-POWs (7.2 vs 5.4, respectively; P = .002), a higher mean number of diagnosed health conditions (9.4 vs 7.7, respectively; P < .001), and used a greater mean number of medications (4.5 vs 3.4, respectively; P = .001). Among 15 broad categories of diagnoses, differences were found in gastrointestinal disorders (FPOWs 63% vs non-POWs 49%, P = .032), musculoskeletal disorders (FPOWs 76% vs non-POWs 60%, P = .001), and cognitive disorders (FPOWs 31% vs non-POWs 15%, P = .006). FPOWs had a significantly higher proportion of 7 extrapyramidal signs and 6 signs relating to ataxia. On the Instrumental Activities of Daily Living scale, FPOWs were more likely to be impaired than were non-POWs (33% vs 17%, respectively; P = .01). In addition, FPOWs have an increased risk of developing dementia, and this risk is doubled in FPOWs with posttraumatic stress disorder (PTSD) compared with non-FPOWs without PTSD.5
These data indicate that FPOW status is associated with increased risk of disability and loss of independence. Federal statutes established the presumption of a relationship between FPOW status and many comorbidities for VA disability determinations in recognition of such data and to overcome lack of medical records during POW confinement and to accord benefit of the doubt where medical science cannot conclusively link disease etiology to FPOW status, to FPOWs.
Service-Connected Conditions
The historical development of conditions with a presumption of service connection for adjudication of VA compensation/disability claims began in 1921 with the Act to Establish a Veterans’ Bureau and to Improve the Facilities.1 The act simplified and streamlined the claims adjudication process by eliminating the need to obtain evidence on the part of the veteran. The presumption of service connection also facilitated increased accuracy and consistency in adjudications by requiring similar treatment for similar claims. This “presumptive” process relieved claimants and VA of the necessity of producing direct evidence when it was impractical to do so.
In 1970, the first presumptives specific to FPOWs were legislatively established and covered 17 diseases for a FPOW who had been confined for ≥ 30 days (Pub. L. 91-376). The 30-day confinement requirement was later relaxed, and additional presumptives were established that related to diseases that were more common among FPOWs than they were among non-FPOWs. These disorders included traumatic arthritis, stroke, heart disease, osteoporosis, peripheral neuropathy, cold injuries, as well as a variety of digestive and neuropsychiatric disorders. If a FPOW is diagnosed as having ≥ 1 of these conditions and it is judged to be ≥ 10% disabling, the condition is presumed to be a sequelae of the POW experience, and it is classified as a service-connected disability (Table).
FPOW Care And Benefits Teams
Several Veterans Health Administration (VHA) directives have been issued, including the recent VHA directive 1650, which requires that each VHA medical facility have a special Care and Benefits Team (CBT) that is charged with the evaluation and treatment of FPOWs to ensure that “FPOWs receive the highest quality care and benefit services.”6 CBTs must be composed of a clinician trained in internal medicine or family practice; a clinician who is certified through the VA Office of Disability and Medical Assessment to conduct General Medical Compensation and Pension evaluations; a FPOW advocate who typically is a VHA clinical social worker; and a Veterans Benefits Administration (VBA) FPOW coordinator appointed by the local VBA regional office. CBTs can be expanded to include other members as needed. The CBTs are tasked with facilitating interactions between FPOWs, the VHA, and the VBA.
CBTs face several challenges in meeting their responsibilities. For example, the POW experience often results in psychological trauma that foments denial and distrust; hence, thoughtful sensitivity to the sequelae of captivity when approaching FPOWs about personal issues, such as health care, is required. Establishing trusting relationships with FPOWs is necessary if their needs are to be effectively addressed.
While the VHA is mandated to provide priority treatment for FPOWs, including hospital, nursing home, dental, and outpatient treatment, a significant number of FPOWs do not avail themselves of benefits to which they are entitled. Often these FPOWs have not used VA programs and facilities because they are uninformed or confused about VA benefits for FPOWs. As a result, referrals of eligible FPOWs to appropriate programs can be overlooked. Maximizing the service-connected disability rating of FPOWs not only impacts the disability pensions received by these veterans, but also impacts their eligibility for VHA programs, including long-term care and Dependency and Indemnity Compensation, a monthly benefit paid to spouses, children, and/or surviving parents.
In 2013, the FPOW Committee of the South Texas Veterans Health Care System (STVHCS) noted that 40% of FPOWs in our region had no VA primary care or clinic assignment. In consideration of the commitment of the VA to care for FPOWs, the unique POW-related medical and psychological issues, the geriatric age of many FPOWs, and the surprising number of FPOWs currently not receiving VA care, we expanded the concept of the CBT team to create a specialized interdisciplinary FPOW Clinic to address the unique needs of this predominantly elderly population and to involve more FPOWs in the VA system.
The main purpose of this clinic was to advise FPOWs of all VA benefits and services to which they may be entitled by identifying overlooked FPOW presumptives. As the number of FPOWs continues to decrease, outreach to FPOWs and family members has become critical, especially as increased benefits and special services might be available to this increasingly dependent older population. An informal survey of FPOW advocates across the nation found that 21% of FPOWs had disability ratings from the VA of ≤ 60%, including some who had no VA disability rating at all. Thus, an additional goal of the project was to develop a clinic model that could be disseminated throughout the VHA.
Design
The design of the FPOW Clinic team is based on an interdisciplinary model that has proven successful in geriatric medicine.7 The team comprises a physician, a social worker, and a registered nurse.8 All members have expertise in geriatric medicine and specific training in FPOW-related issues by completing a VA employee education training session on FPOW case management. Completion of this training ensured that team members were:
- Familiar with the experiences of FPOWs as well as about the medical, psychosocial, and mental health conditions that affect FPOWs;
- Knowledgeable about FPOW presumptive conditions;
- Familiar with the VBA process for rating FPOW disability claims; and
- Capable of FPOW case coordination, workflow, and communications between the FPOW Clinic team and the VBA to avail FPOWs and their families of all eligible benefits.
In-person FPOW clinic visits and chart reviews helped identify overlooked FPOW benefits. To facilitate case management, a representative of the VBA attended the initial evaluation of each FPOW in the clinic to confirm any overlooked presumptive benefits and to familiarize FPOWs with the claims process. FPOWs were also given the choice to officially enroll in the FPOW clinic for primary care or to remain with their current health care provider. Special efforts were made to enroll those FPOWs who had no STVHCS assigned primary care clinic.
The clinic was scheduled for 4 hours every week. Initial patient visits were 2 hours each and consisted of separate evaluations by each of the 3 FPOW Clinic team members who then met as a team with the addition of the VBA representative. The purpose of this meeting was to discuss overlooked benefits, address any other specific issues noted, and to devise an appropriate interdisciplinary plan. Findings of overlooked benefits and other relevant outcomes then were conveyed to the FPOW. For FPOWs who opted to continue in the clinic for their primary care, subsequent appointments were 1 hour.
Implementation
STVHCS FPOW advocates identified and sent letters to FPOWs announcing the opening of the clinic and its goals. Phone calls were made to each FPOW to address questions and to ascertain their interest. The FPOW advocates then worked directly with schedulers to make clinic appointments. Forty-one FPOWs responded to this initial invitation and attended the new clinic. Subsequently, this number increased through FPOW consults placed by STVHCS primary care providers.
The service-connected disability rating of clinic patients ranged from none (6% of attendees) to 100% (28% of attendees). For 34% of patients, clinic attendance resulted in identification application for overlooked presumptives. VBA evaluation resulted in increased service-connected disability ratings for nearly one-third of clinic patients. All clinic patients without a service-connected disability prior to FPOW clinic evaluation received an increased service-connected disability rating. Overall, 60% of the FPOWs who attended the clinic opted to receive their primary care at the FPOW clinic.
The FPOW Clinic successfully identified overlooked presumptives and facilitated the determination of appropriate service-connected disabilities. Interestingly, the FPOW Clinic encountered an unanticipated challenge to identifying overlooked FPOW benefits—veterans’ medical conditions that are listed by the VHA as being service-connected in the Computerized Patient Record System did not always reflect those listed officially in VBA records. This led to occasional identification of apparently overlooked FPOW presumptives that were already recognized by the VBA but not reflected in VHA records. This issue was addressed by ensuring that VBA representatives attended postclinic meetings with clinic staff and avoided the need to pursue supposedly unrecognized benefits that were recognized.
Telehealth
At present, FPOWs from World War II outnumber those of all other conflicts; however, this group is rapidly dwindling in numbers. World War II FPOWs are aged > 85 years, and therefore among the most frail and dependent of veterans. Often they are homebound and unable to physically travel to clinics for assessment. To serve these veterans, we are modifying the FPOW Clinic to utilize telehealth. The Telehealth FPOW Clinic will obtain relevant data from review of the electronic health record and telehealth-based clinic visits. Telehealth also may be used for assessments of Vietnam War veterans (eg, Agent Orange exposure), atomic veterans, and Gulf War veterans. Once fully designed and implemented, we believe that telehealth will prove to be a cost-effective way to provide clinic benefits to rural and older veterans.
Conclusions
The VHA provides priority medical treatment to FPOWs as well as timely and appropriate assessment of their eligibility for veterans’ benefits. The complexities benefit programs established for FPOWs is often beyond the ken of VHA physicians, social workers, and nurses. Because of this unfamiliarity, referrals of eligible FPOWs to appropriate programs can be overlooked. We established a clinic-based interdisciplinary team (FPOW Clinic) that was fully trained in FPOW benefit programs to identify overlooked benefits for FPOWs and were able to increase the disability rating on approximately one-third of the FPOWs seen in the FPOW Clinic. A telehealth-based version of the FPOW clinic is now being developed.
Since the beginning of the American Republic, servicemen have been captured and held as prisoners of war (POWs), including > 130,000 in World War II , > 7,100 in the Korean War, > 700 in the Vietnam War, and 37 in Operation Desert Storm and recent conflicts.1,2 Also, > 80 servicewomen have been held during these conflicts.1-3 Of those living former POWs (FPOWs), almost all are geriatric (aged > 65 years) with a significant portion aged ≥ 85 years.
The physical hardships and psychological stress endured by FPOWs have lifelong deleterious sequelae on health and social functioning.3-5 The experiences of FPOWs are associated with higher prevalence of chronic diseases and diminished functional performance in later life as demonstrated by a survey of FPOWs from World War II.4 The survey assessed health and functional status in a random sample of 101 FPOWs and a group of 107 non-POW combatants from the same military operations. FPOWs reported a higher mean number of somatic symptoms than did non-POWs (7.2 vs 5.4, respectively; P = .002), a higher mean number of diagnosed health conditions (9.4 vs 7.7, respectively; P < .001), and used a greater mean number of medications (4.5 vs 3.4, respectively; P = .001). Among 15 broad categories of diagnoses, differences were found in gastrointestinal disorders (FPOWs 63% vs non-POWs 49%, P = .032), musculoskeletal disorders (FPOWs 76% vs non-POWs 60%, P = .001), and cognitive disorders (FPOWs 31% vs non-POWs 15%, P = .006). FPOWs had a significantly higher proportion of 7 extrapyramidal signs and 6 signs relating to ataxia. On the Instrumental Activities of Daily Living scale, FPOWs were more likely to be impaired than were non-POWs (33% vs 17%, respectively; P = .01). In addition, FPOWs have an increased risk of developing dementia, and this risk is doubled in FPOWs with posttraumatic stress disorder (PTSD) compared with non-FPOWs without PTSD.5
These data indicate that FPOW status is associated with increased risk of disability and loss of independence. Federal statutes established the presumption of a relationship between FPOW status and many comorbidities for VA disability determinations in recognition of such data and to overcome lack of medical records during POW confinement and to accord benefit of the doubt where medical science cannot conclusively link disease etiology to FPOW status, to FPOWs.
Service-Connected Conditions
The historical development of conditions with a presumption of service connection for adjudication of VA compensation/disability claims began in 1921 with the Act to Establish a Veterans’ Bureau and to Improve the Facilities.1 The act simplified and streamlined the claims adjudication process by eliminating the need to obtain evidence on the part of the veteran. The presumption of service connection also facilitated increased accuracy and consistency in adjudications by requiring similar treatment for similar claims. This “presumptive” process relieved claimants and VA of the necessity of producing direct evidence when it was impractical to do so.
In 1970, the first presumptives specific to FPOWs were legislatively established and covered 17 diseases for a FPOW who had been confined for ≥ 30 days (Pub. L. 91-376). The 30-day confinement requirement was later relaxed, and additional presumptives were established that related to diseases that were more common among FPOWs than they were among non-FPOWs. These disorders included traumatic arthritis, stroke, heart disease, osteoporosis, peripheral neuropathy, cold injuries, as well as a variety of digestive and neuropsychiatric disorders. If a FPOW is diagnosed as having ≥ 1 of these conditions and it is judged to be ≥ 10% disabling, the condition is presumed to be a sequelae of the POW experience, and it is classified as a service-connected disability (Table).
FPOW Care And Benefits Teams
Several Veterans Health Administration (VHA) directives have been issued, including the recent VHA directive 1650, which requires that each VHA medical facility have a special Care and Benefits Team (CBT) that is charged with the evaluation and treatment of FPOWs to ensure that “FPOWs receive the highest quality care and benefit services.”6 CBTs must be composed of a clinician trained in internal medicine or family practice; a clinician who is certified through the VA Office of Disability and Medical Assessment to conduct General Medical Compensation and Pension evaluations; a FPOW advocate who typically is a VHA clinical social worker; and a Veterans Benefits Administration (VBA) FPOW coordinator appointed by the local VBA regional office. CBTs can be expanded to include other members as needed. The CBTs are tasked with facilitating interactions between FPOWs, the VHA, and the VBA.
CBTs face several challenges in meeting their responsibilities. For example, the POW experience often results in psychological trauma that foments denial and distrust; hence, thoughtful sensitivity to the sequelae of captivity when approaching FPOWs about personal issues, such as health care, is required. Establishing trusting relationships with FPOWs is necessary if their needs are to be effectively addressed.
While the VHA is mandated to provide priority treatment for FPOWs, including hospital, nursing home, dental, and outpatient treatment, a significant number of FPOWs do not avail themselves of benefits to which they are entitled. Often these FPOWs have not used VA programs and facilities because they are uninformed or confused about VA benefits for FPOWs. As a result, referrals of eligible FPOWs to appropriate programs can be overlooked. Maximizing the service-connected disability rating of FPOWs not only impacts the disability pensions received by these veterans, but also impacts their eligibility for VHA programs, including long-term care and Dependency and Indemnity Compensation, a monthly benefit paid to spouses, children, and/or surviving parents.
In 2013, the FPOW Committee of the South Texas Veterans Health Care System (STVHCS) noted that 40% of FPOWs in our region had no VA primary care or clinic assignment. In consideration of the commitment of the VA to care for FPOWs, the unique POW-related medical and psychological issues, the geriatric age of many FPOWs, and the surprising number of FPOWs currently not receiving VA care, we expanded the concept of the CBT team to create a specialized interdisciplinary FPOW Clinic to address the unique needs of this predominantly elderly population and to involve more FPOWs in the VA system.
The main purpose of this clinic was to advise FPOWs of all VA benefits and services to which they may be entitled by identifying overlooked FPOW presumptives. As the number of FPOWs continues to decrease, outreach to FPOWs and family members has become critical, especially as increased benefits and special services might be available to this increasingly dependent older population. An informal survey of FPOW advocates across the nation found that 21% of FPOWs had disability ratings from the VA of ≤ 60%, including some who had no VA disability rating at all. Thus, an additional goal of the project was to develop a clinic model that could be disseminated throughout the VHA.
Design
The design of the FPOW Clinic team is based on an interdisciplinary model that has proven successful in geriatric medicine.7 The team comprises a physician, a social worker, and a registered nurse.8 All members have expertise in geriatric medicine and specific training in FPOW-related issues by completing a VA employee education training session on FPOW case management. Completion of this training ensured that team members were:
- Familiar with the experiences of FPOWs as well as about the medical, psychosocial, and mental health conditions that affect FPOWs;
- Knowledgeable about FPOW presumptive conditions;
- Familiar with the VBA process for rating FPOW disability claims; and
- Capable of FPOW case coordination, workflow, and communications between the FPOW Clinic team and the VBA to avail FPOWs and their families of all eligible benefits.
In-person FPOW clinic visits and chart reviews helped identify overlooked FPOW benefits. To facilitate case management, a representative of the VBA attended the initial evaluation of each FPOW in the clinic to confirm any overlooked presumptive benefits and to familiarize FPOWs with the claims process. FPOWs were also given the choice to officially enroll in the FPOW clinic for primary care or to remain with their current health care provider. Special efforts were made to enroll those FPOWs who had no STVHCS assigned primary care clinic.
The clinic was scheduled for 4 hours every week. Initial patient visits were 2 hours each and consisted of separate evaluations by each of the 3 FPOW Clinic team members who then met as a team with the addition of the VBA representative. The purpose of this meeting was to discuss overlooked benefits, address any other specific issues noted, and to devise an appropriate interdisciplinary plan. Findings of overlooked benefits and other relevant outcomes then were conveyed to the FPOW. For FPOWs who opted to continue in the clinic for their primary care, subsequent appointments were 1 hour.
Implementation
STVHCS FPOW advocates identified and sent letters to FPOWs announcing the opening of the clinic and its goals. Phone calls were made to each FPOW to address questions and to ascertain their interest. The FPOW advocates then worked directly with schedulers to make clinic appointments. Forty-one FPOWs responded to this initial invitation and attended the new clinic. Subsequently, this number increased through FPOW consults placed by STVHCS primary care providers.
The service-connected disability rating of clinic patients ranged from none (6% of attendees) to 100% (28% of attendees). For 34% of patients, clinic attendance resulted in identification application for overlooked presumptives. VBA evaluation resulted in increased service-connected disability ratings for nearly one-third of clinic patients. All clinic patients without a service-connected disability prior to FPOW clinic evaluation received an increased service-connected disability rating. Overall, 60% of the FPOWs who attended the clinic opted to receive their primary care at the FPOW clinic.
The FPOW Clinic successfully identified overlooked presumptives and facilitated the determination of appropriate service-connected disabilities. Interestingly, the FPOW Clinic encountered an unanticipated challenge to identifying overlooked FPOW benefits—veterans’ medical conditions that are listed by the VHA as being service-connected in the Computerized Patient Record System did not always reflect those listed officially in VBA records. This led to occasional identification of apparently overlooked FPOW presumptives that were already recognized by the VBA but not reflected in VHA records. This issue was addressed by ensuring that VBA representatives attended postclinic meetings with clinic staff and avoided the need to pursue supposedly unrecognized benefits that were recognized.
Telehealth
At present, FPOWs from World War II outnumber those of all other conflicts; however, this group is rapidly dwindling in numbers. World War II FPOWs are aged > 85 years, and therefore among the most frail and dependent of veterans. Often they are homebound and unable to physically travel to clinics for assessment. To serve these veterans, we are modifying the FPOW Clinic to utilize telehealth. The Telehealth FPOW Clinic will obtain relevant data from review of the electronic health record and telehealth-based clinic visits. Telehealth also may be used for assessments of Vietnam War veterans (eg, Agent Orange exposure), atomic veterans, and Gulf War veterans. Once fully designed and implemented, we believe that telehealth will prove to be a cost-effective way to provide clinic benefits to rural and older veterans.
Conclusions
The VHA provides priority medical treatment to FPOWs as well as timely and appropriate assessment of their eligibility for veterans’ benefits. The complexities benefit programs established for FPOWs is often beyond the ken of VHA physicians, social workers, and nurses. Because of this unfamiliarity, referrals of eligible FPOWs to appropriate programs can be overlooked. We established a clinic-based interdisciplinary team (FPOW Clinic) that was fully trained in FPOW benefit programs to identify overlooked benefits for FPOWs and were able to increase the disability rating on approximately one-third of the FPOWs seen in the FPOW Clinic. A telehealth-based version of the FPOW clinic is now being developed.
1. Henning CA; Congressional Research Service. POWs and MIAs: status and accounting issues. https://fas.org/sgp/crs/natsec/RL33452.pdf. Published June 1, 2006. Accessed March 16, 2020.
2. Klein RE, Wells MR, Somers JM. American Prisoners of War (POWs) and Missing in Action (MIAs). Washington, DC: US Department of Veterans Affairs, Office of Policy, Planning, and Preparedness; 2006.
3. Skelton WP 3rd. American ex-prisoners of war. https://m.vfwilserviceoffice.com/upload/VA%20Report%20on%20Former%20POWs.pdf. Updated April 2002. Accessed March 16, 2020.
4. Creasey H, Sulway MR, Dent O, Broe GA, Jorm A, Tennant C. Is experience as a prisoner of war a risk factor for accelerated age-related illness and disability? J Am Geriatr Soc. 1999;47(1):60-64.
5. Meziab O, Kirby KA, Williams B, Yaffe K, Byers AL, Barnes DE. Prisoner of war status, posttraumatic stress disorder, and dementia in older veterans. Alzheimers Dement. 2014;10(3)(suppl):S236-S241.
6. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1650. Special Care and Benefits Teams Evaluating or Treating Former Prisoners of War. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7481. Published July 31, 2018. Accessed March 16, 2020.
7. Boult C, Boult LB, Morishita L, Dowd B, Kane RL, Urdangarin CF. A randomized clinical trial of outpatient geriatric evaluation and management. J Am Geriatr Soc. 2001;49(4):351-359.
8. Kellogg, DL Jr. Geriatric Research, Education and Clinical Center (GRECC): former prisoners of war (FPOW) clinic, methods, procedures & training manual. https://www.southtexas.va.gov/grecc/docs/FPOW_toolkit.pdf. Updated January 28, 2015. Accessed March 16, 2020.
1. Henning CA; Congressional Research Service. POWs and MIAs: status and accounting issues. https://fas.org/sgp/crs/natsec/RL33452.pdf. Published June 1, 2006. Accessed March 16, 2020.
2. Klein RE, Wells MR, Somers JM. American Prisoners of War (POWs) and Missing in Action (MIAs). Washington, DC: US Department of Veterans Affairs, Office of Policy, Planning, and Preparedness; 2006.
3. Skelton WP 3rd. American ex-prisoners of war. https://m.vfwilserviceoffice.com/upload/VA%20Report%20on%20Former%20POWs.pdf. Updated April 2002. Accessed March 16, 2020.
4. Creasey H, Sulway MR, Dent O, Broe GA, Jorm A, Tennant C. Is experience as a prisoner of war a risk factor for accelerated age-related illness and disability? J Am Geriatr Soc. 1999;47(1):60-64.
5. Meziab O, Kirby KA, Williams B, Yaffe K, Byers AL, Barnes DE. Prisoner of war status, posttraumatic stress disorder, and dementia in older veterans. Alzheimers Dement. 2014;10(3)(suppl):S236-S241.
6. US Department of Veterans Affairs, Veterans Health Administration. VHA Directive 1650. Special Care and Benefits Teams Evaluating or Treating Former Prisoners of War. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7481. Published July 31, 2018. Accessed March 16, 2020.
7. Boult C, Boult LB, Morishita L, Dowd B, Kane RL, Urdangarin CF. A randomized clinical trial of outpatient geriatric evaluation and management. J Am Geriatr Soc. 2001;49(4):351-359.
8. Kellogg, DL Jr. Geriatric Research, Education and Clinical Center (GRECC): former prisoners of war (FPOW) clinic, methods, procedures & training manual. https://www.southtexas.va.gov/grecc/docs/FPOW_toolkit.pdf. Updated January 28, 2015. Accessed March 16, 2020.
U.S. hospitals facing severe challenges from COVID-19, HHS report says
Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).
From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.
The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.
The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.
To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.
Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.
The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.
As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”
Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
Supply Shortages
The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.
Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.
Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.
To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.
Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.
Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.
Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.
Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.
Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
What Hospitals Want
As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.
“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.
This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.
Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.
Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:
- Let them reassign licensed professionals within their hospitals and across healthcare networks
- Provide flexibility with respect to licensed professionals practicing across state lines
- Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships
This article first appeared on Medscape.com.
Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).
From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.
The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.
The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.
To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.
Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.
The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.
As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”
Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
Supply Shortages
The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.
Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.
Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.
To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.
Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.
Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.
Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.
Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.
Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
What Hospitals Want
As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.
“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.
This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.
Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.
Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:
- Let them reassign licensed professionals within their hospitals and across healthcare networks
- Provide flexibility with respect to licensed professionals practicing across state lines
- Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships
This article first appeared on Medscape.com.
Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).
From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.
The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.
The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.
To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.
Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.
The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.
As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”
Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
Supply Shortages
The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.
Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.
Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.
To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.
Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.
Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.
Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.
Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.
Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
What Hospitals Want
As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.
“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.
This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.
Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.
Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:
- Let them reassign licensed professionals within their hospitals and across healthcare networks
- Provide flexibility with respect to licensed professionals practicing across state lines
- Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships
This article first appeared on Medscape.com.
Aerosolization of COVID-19 and Contamination Risks During Respiratory Treatments
Beyond asthma and chronic obstructive pulmonary disease (COPD), inhalation therapy is a mainstay in the management of bronchiectasis, cystic fibrosis, and pulmonary artery hypertension. Several US Food and Drug Administration off-label indications for inhalational medications include hypoxia secondary to acute respiratory distress syndrome (ARDS) and intraoperative and postoperative pulmonary hypertension during and following cardiac surgery, respectively.1-11 Therapeutic delivery of aerosols to the lung may be provided via nebulization, pressurized metered-dose inhalers (pMDI), and other devices (eg, dry powder inhalers, soft-mist inhalers, and smart inhalers).12 The most common aerosolized medications given in the clinical setting are bronchodilators.12
Product selection is often guided by practice guidelines (Table 1), consideration of the formulation’s advantages and disadvantages (Table 2), and/or formulary considerations. For example, current guidelines for COPD state that there is no evidence for superiority of nebulized bronchodilator therapy over handheld devices in patients who can use them properly.2 Due to equivalence, nebulized formulations are commonly used in hospitals, emergency departments (EDs) and ambulatory clinics based on the drug’s unit cost. In contrast, a pMDI is often more cost-effective for use in ambulatory patients who are administering multiple doses from the same canister.
The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend droplet and contact precautions for all patients suspected or diagnosed with novel coronavirus-19 (COVID-19).13,14 Airborne precautions must be applied when performing aerosol-generating medical procedures (AGMPs), including but not limited to, open suctioning of the respiratory tract, intubation, bronchoscopy, and cardiopulmonary resuscitation (CPR). Data from the severe acute respiratory syndrome (SARS-CoV) epidemic suggest that nebulization of medication is also an AGMP.15-17
Institutions must ensure that their health care workers (HCWs) are wearing appropriate personal protective equipment (PPE) including gloves, long-sleeved gowns, eye protection, and fit-tested particulate respirators (N95 mask) for airborne procedures and are carefully discarding PPE after use.13,14 Due to severe shortages in available respirators in the US supply chain, the CDC has temporarily modified WHO recommendations. Face masks are now an acceptable alternative to protect HCWs from splashes and sprays from procedures not likely to generate aerosols and for cleaning of rooms, although there is no evidence to support this decision.
Internationally, HCWs are falling ill with COVID-19. Data from Italy and Spain show that about 9% to 13% of these countries’ cases are HCWs.18,19 Within the US, the Ohio health department reports approximately 16% of cases are HCWs.20 It is possible that 20% of frontline HCWs will become infected.21 Evolving laboratory research shows that COVID-19 remains viable in aerosols for up to 3 hours postaerosolization, thus making aerosol transmission plausible.22 Nebulizers convert liquids into aerosols and during dispersal may potentially cause secondary inhalation of fugitive emissions.23 Since interim CDC infection control guidance is to allow only essential personnel to enter the room of patients with COVID-19, many facilities will rely on their frontline nursing staff to clean and disinfect high-touch surfaces following routine care activities.24
Achieving adequate fomite disinfection following viral aerosolization may pose a significant problem for any patient receiving scheduled doses of nebulized medications. Additionally, for personnel who clean rooms following intermittent drug nebulization while wearing PPE that includes a face mask, protection from aerosolized virus may be inadequate. Subsequently, fugitive emissions from nebulized medications may potentially contribute to both nosocomial COVID-19 transmission and viral infections in the medical staff until proven otherwise by studies conducted outside of the laboratory. Prevention of infection in the medical staff is imperative since federal health care systems cannot sustain a significant loss of its workforce.
Recommendations
We recommend that health care systems stop business as usual and adopt public health recommendations issued by Canadian and Hong Kong health care authorities for the management of suspected or confirmed COVID-19 disease.25-28 We have further clarified and expanded on these interventions. During viral pandemics, prescribers and health care systems should:
- Deprescribe nebulized therapies on medical wards and intensive care units as an infection control measure. Also avoid use in any outpatient health care setting (eg, community-based clinics, EDs, triage).
- Avoid initiation of nebulized unproven therapies (eg, n-acetylcysteine, hypertonic saline).1
- Use alternative bronchodilator formulations as appropriate (eg, oral β-2 agonist, recognizing its slower onset) before prescribing nebulized agents to patients who are uncooperative or unable to follow directions needed to use a pMDI with a spacer or have experienced a prior poor response to a pMDI with spacer (eg, OptiChamber Diamond, Philips).25,27
- Limit nebulized drug utilization (eg, bronchodilators, epoprostenol) to patients who are on mechanical ventilation and will receive nebulized therapies via a closed system or to patients housed in negative pressure hospital rooms.22 Use a viral filter (eg, Salter Labs system) to decrease the spread of infection for those receiving epoprostenol via face mask.25
- Adjust procurement practices (eg, pharmacy, logistics) to address the transition from nebulized drugs to alternatives.
- Add a safety net to the drug-ordering process by restricting new orders for nebulized therapies to the prior authorization process.27 Apply the exclusion criterion of suspected or definite COVID-19.
- Add a safety net to environmental service practices. Nursing staff should track patients who received ≥ 1 nebulizations via open (before diagnosis) or closed systems so that staff wear suitable PPE to include a N-95 mask while cleaning the room.
Conclusions
To implement the aggressive infection control guidance promulgated here, we recommend collaboration with infection control, pharmacy service (eg, prior authorization team, clinical pharmacy team, and procurement team), respiratory therapy, pulmonary and other critical care physicians, EDs, CPR committee, and other stakeholders. When making significant transitions in clinical care during a viral pandemic, guidelines must be timely, use imperative wording, and consist of easily identifiable education and/or instructions for the affected frontline staff in order to change attitudes.29 Additionally, when transitioning from nebulized bronchodilators to pMDI, educational in-services should be provided to frontline staff to avoid misconceptions regarding pMDI treatment efficacy and patients’ ability to use their pMDI with spacer.30
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville.
1. Strickland SL, Rubin BK, Haas CF, Volsko TA, Drescher GS, O’Malley CA. AARC Clinical Practice Guideline: effectiveness of pharmacologic airway clearance therapies in hospitalized patients. Respir Care. 2015;60(7):1071-1077.
2. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2020 GOLD Report. https://goldcopd.org/gold-reports/. Accessed March 26, 2020.
3. Van Geffen WH, Douma WR, Slebos DJ, Kerstjens HAM. Bronchodilators delivered by nebulizer versus pMDI with spacer or DPI for exacerbations of COPD (Review). Cochrane Database Syst Rev. 2016;8:CD011826.
4. Global Initiative for Asthma. https://ginasthma.org/wp-content/uploads/2019/06/GINA-2019-main-report-June-2019-wms.pdf. Accessed March 26, 2020.
5. Global Initiative for Asthma. Difficult-to-treat and severe asthma in adolescent and adult patients: diagnosis and management. https://ginasthma.org/wp-content/uploads/2019/04/GINA-Severe-asthma-Pocket-Guide-v2.0-wms-1.pdf. Accessed March 26, 2020.
6. Cates CJ, Welsh EJ, Rowe BH. Holding chambers (spacers) versus nebulizers for beta-agonist treatment of acute asthma. Cochrane Database Syst Rev. 2013;9:CD000052.
7. Welsh EJ, Evans DJ, Fowler SJ, Spencer S. Interventions for bronchiectasis: an overview of Cochrane systematic reviews. Cochrane Database Syst Rev. 2015;7:CD010337.
8. Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial hypertension in adults: CHEST Guideline and Expert Panel Report. CHEST. 2014;146(2):449-475.
9. Griffiths MJD, McAuley DF, Perkins GD, et al. Guidelines on the management of acute respiratory distress syndrome. BMJ Open Resp Res. 2019;6(1):e000420.
10. McGinn K, Reichert M. A comparison of inhaled nitric oxide versus inhaled epoprostenol for acute pulmonary hypertension following cardiac surgery. Ann Pharmacother. 2016;50(1):22-26.
11. Dzierba AL, Abel EE, Buckley MS, Lat I. A review of inhaled nitric oxide and aerosolized epoprostenol in acute lung injury or acute respiratory distress syndrome. Pharmacotherapy. 2014;34(3):279-290.
12. Pleasants RA, Hess DR. Aerosol delivery devices for obstructive lung diseases. Respir Care. 2018;63(6):708-733.
13. World Health Organization. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected. https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected Accessed March 26, 2020.
14. Centers for Disease Control and Prevention. Interim clinical guidance for management of patients with confirmed coronavirus disease (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html. Revised March 7, 2020. Accessed March 26, 2020.
15. Wong RSM, Hui DS. Index patient and SARS outbreak in Hong Kong. Emerg Infect Dis. 2004;10(2):339-341.
16. Wong T-W, Lee C-K, Tam W, et al; Outbreak Study Group. Emerg Infect Dis. 2004;10(2):269-276.
17. Seto WH, Tsang D, Yung RWH, et al; Advisors of Expert SARS group of Hospital Authority. Effectiveness of precautions against droplets and contact in prevention of nosocomial transmission of severe acute respiratory syndrome (SARS). Lancet. 2003;361(9368):1519-1520.
18. Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. https://jamanetwork.com/journals/jama/fullarticle/2763401?resultClick=1. Published March 17, 2020. Accessed March 26, 2020.
19. Jones S. Spain: doctors struggle to cope as 514 die from coronavirus in a day. The Guardian. March 24, 2020. https://www.theguardian.com/world/2020/mar/24/spain-doctors-lack-protection-coronavirus-covid-19. Accessed March 27, 2020.
20. 16% of Ohio’s diagnosed COVID-19 cases are healthcare workers. https://www.wlwt.com/article/16-of-ohio-s-diagnosed-covid-19-cases-are-healthcare-workers/31930566#. Updated March 25, 2020. Accessed March 27, 2020.
21. Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30627-9/fulltext. Accessed March 27, 2020.
22. van Doremalen N, Bushmaker T, Morris DH, et al. Aerosol and surface stability of SARS-CoV-2 as Compared with SARS-CoV-1 [published online ahead of print, 2020 Mar 17]. N Engl J Med. 2020;10.1056/NEJMc2004973.
23. McGrath JA, O’Sullivan A, Bennett G, et al. Investigation of the quantity of exhaled aerosol released into the environment during nebulization. Pharmaceutics. 2019;11(2):75.
24. Centers for Disease Control and Prevention. Healthcare Infection prevention and control FAQs for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/infection-control/infection-prevention-control-faq.html. Revised March 24, 2020. Accessed March 26, 2020.
25. Practice standards of respiratory procedures: post SARS era. Use of aerosolized medications. December 2003. http://www.hkresp.com/hkts.php?page=page/hkts/detail&meid=93742. Accessed March 26, 2020.
26. Wax RS, Christian MD. Practical recommendations for critical care and anesthesiology teams caring for novel coronavirus (2019-nCoV) patients. Can J Anesth. 2020. [ePub ahead of print.]
27. Newhouse MT. RE: transmission of coronavirus by nebulizer- as serious, underappreciated risk! https://www.cmaj.ca/content/re-transmission-corona-virus-nebulizer-serious-underappreciated-risk. Accessed March 26, 2020. [ePub ahead of print.]
28. Moira C-Y. Severe acute respiratory syndrome (SARS) and healthcare workers. Int J Occup Environ Health. 2004;10(4):421-427.
29. Timen A, Hulscher MEJL, Rust L, et al. Barriers to implementing infection prevention and control guidelines during crises: experiences of health care professionals. Am J Infect Control. 2010;38(9):726-733.
30. Khoo SM, Tan LK, Said N, Lim TK. Metered-dose inhaler with spacer instead of nebulizer during the outbreak of severe acute respiratory syndrome in Singapore. Respir Care. 2009;54(7):855-860.
Beyond asthma and chronic obstructive pulmonary disease (COPD), inhalation therapy is a mainstay in the management of bronchiectasis, cystic fibrosis, and pulmonary artery hypertension. Several US Food and Drug Administration off-label indications for inhalational medications include hypoxia secondary to acute respiratory distress syndrome (ARDS) and intraoperative and postoperative pulmonary hypertension during and following cardiac surgery, respectively.1-11 Therapeutic delivery of aerosols to the lung may be provided via nebulization, pressurized metered-dose inhalers (pMDI), and other devices (eg, dry powder inhalers, soft-mist inhalers, and smart inhalers).12 The most common aerosolized medications given in the clinical setting are bronchodilators.12
Product selection is often guided by practice guidelines (Table 1), consideration of the formulation’s advantages and disadvantages (Table 2), and/or formulary considerations. For example, current guidelines for COPD state that there is no evidence for superiority of nebulized bronchodilator therapy over handheld devices in patients who can use them properly.2 Due to equivalence, nebulized formulations are commonly used in hospitals, emergency departments (EDs) and ambulatory clinics based on the drug’s unit cost. In contrast, a pMDI is often more cost-effective for use in ambulatory patients who are administering multiple doses from the same canister.
The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend droplet and contact precautions for all patients suspected or diagnosed with novel coronavirus-19 (COVID-19).13,14 Airborne precautions must be applied when performing aerosol-generating medical procedures (AGMPs), including but not limited to, open suctioning of the respiratory tract, intubation, bronchoscopy, and cardiopulmonary resuscitation (CPR). Data from the severe acute respiratory syndrome (SARS-CoV) epidemic suggest that nebulization of medication is also an AGMP.15-17
Institutions must ensure that their health care workers (HCWs) are wearing appropriate personal protective equipment (PPE) including gloves, long-sleeved gowns, eye protection, and fit-tested particulate respirators (N95 mask) for airborne procedures and are carefully discarding PPE after use.13,14 Due to severe shortages in available respirators in the US supply chain, the CDC has temporarily modified WHO recommendations. Face masks are now an acceptable alternative to protect HCWs from splashes and sprays from procedures not likely to generate aerosols and for cleaning of rooms, although there is no evidence to support this decision.
Internationally, HCWs are falling ill with COVID-19. Data from Italy and Spain show that about 9% to 13% of these countries’ cases are HCWs.18,19 Within the US, the Ohio health department reports approximately 16% of cases are HCWs.20 It is possible that 20% of frontline HCWs will become infected.21 Evolving laboratory research shows that COVID-19 remains viable in aerosols for up to 3 hours postaerosolization, thus making aerosol transmission plausible.22 Nebulizers convert liquids into aerosols and during dispersal may potentially cause secondary inhalation of fugitive emissions.23 Since interim CDC infection control guidance is to allow only essential personnel to enter the room of patients with COVID-19, many facilities will rely on their frontline nursing staff to clean and disinfect high-touch surfaces following routine care activities.24
Achieving adequate fomite disinfection following viral aerosolization may pose a significant problem for any patient receiving scheduled doses of nebulized medications. Additionally, for personnel who clean rooms following intermittent drug nebulization while wearing PPE that includes a face mask, protection from aerosolized virus may be inadequate. Subsequently, fugitive emissions from nebulized medications may potentially contribute to both nosocomial COVID-19 transmission and viral infections in the medical staff until proven otherwise by studies conducted outside of the laboratory. Prevention of infection in the medical staff is imperative since federal health care systems cannot sustain a significant loss of its workforce.
Recommendations
We recommend that health care systems stop business as usual and adopt public health recommendations issued by Canadian and Hong Kong health care authorities for the management of suspected or confirmed COVID-19 disease.25-28 We have further clarified and expanded on these interventions. During viral pandemics, prescribers and health care systems should:
- Deprescribe nebulized therapies on medical wards and intensive care units as an infection control measure. Also avoid use in any outpatient health care setting (eg, community-based clinics, EDs, triage).
- Avoid initiation of nebulized unproven therapies (eg, n-acetylcysteine, hypertonic saline).1
- Use alternative bronchodilator formulations as appropriate (eg, oral β-2 agonist, recognizing its slower onset) before prescribing nebulized agents to patients who are uncooperative or unable to follow directions needed to use a pMDI with a spacer or have experienced a prior poor response to a pMDI with spacer (eg, OptiChamber Diamond, Philips).25,27
- Limit nebulized drug utilization (eg, bronchodilators, epoprostenol) to patients who are on mechanical ventilation and will receive nebulized therapies via a closed system or to patients housed in negative pressure hospital rooms.22 Use a viral filter (eg, Salter Labs system) to decrease the spread of infection for those receiving epoprostenol via face mask.25
- Adjust procurement practices (eg, pharmacy, logistics) to address the transition from nebulized drugs to alternatives.
- Add a safety net to the drug-ordering process by restricting new orders for nebulized therapies to the prior authorization process.27 Apply the exclusion criterion of suspected or definite COVID-19.
- Add a safety net to environmental service practices. Nursing staff should track patients who received ≥ 1 nebulizations via open (before diagnosis) or closed systems so that staff wear suitable PPE to include a N-95 mask while cleaning the room.
Conclusions
To implement the aggressive infection control guidance promulgated here, we recommend collaboration with infection control, pharmacy service (eg, prior authorization team, clinical pharmacy team, and procurement team), respiratory therapy, pulmonary and other critical care physicians, EDs, CPR committee, and other stakeholders. When making significant transitions in clinical care during a viral pandemic, guidelines must be timely, use imperative wording, and consist of easily identifiable education and/or instructions for the affected frontline staff in order to change attitudes.29 Additionally, when transitioning from nebulized bronchodilators to pMDI, educational in-services should be provided to frontline staff to avoid misconceptions regarding pMDI treatment efficacy and patients’ ability to use their pMDI with spacer.30
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville.
Beyond asthma and chronic obstructive pulmonary disease (COPD), inhalation therapy is a mainstay in the management of bronchiectasis, cystic fibrosis, and pulmonary artery hypertension. Several US Food and Drug Administration off-label indications for inhalational medications include hypoxia secondary to acute respiratory distress syndrome (ARDS) and intraoperative and postoperative pulmonary hypertension during and following cardiac surgery, respectively.1-11 Therapeutic delivery of aerosols to the lung may be provided via nebulization, pressurized metered-dose inhalers (pMDI), and other devices (eg, dry powder inhalers, soft-mist inhalers, and smart inhalers).12 The most common aerosolized medications given in the clinical setting are bronchodilators.12
Product selection is often guided by practice guidelines (Table 1), consideration of the formulation’s advantages and disadvantages (Table 2), and/or formulary considerations. For example, current guidelines for COPD state that there is no evidence for superiority of nebulized bronchodilator therapy over handheld devices in patients who can use them properly.2 Due to equivalence, nebulized formulations are commonly used in hospitals, emergency departments (EDs) and ambulatory clinics based on the drug’s unit cost. In contrast, a pMDI is often more cost-effective for use in ambulatory patients who are administering multiple doses from the same canister.
The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend droplet and contact precautions for all patients suspected or diagnosed with novel coronavirus-19 (COVID-19).13,14 Airborne precautions must be applied when performing aerosol-generating medical procedures (AGMPs), including but not limited to, open suctioning of the respiratory tract, intubation, bronchoscopy, and cardiopulmonary resuscitation (CPR). Data from the severe acute respiratory syndrome (SARS-CoV) epidemic suggest that nebulization of medication is also an AGMP.15-17
Institutions must ensure that their health care workers (HCWs) are wearing appropriate personal protective equipment (PPE) including gloves, long-sleeved gowns, eye protection, and fit-tested particulate respirators (N95 mask) for airborne procedures and are carefully discarding PPE after use.13,14 Due to severe shortages in available respirators in the US supply chain, the CDC has temporarily modified WHO recommendations. Face masks are now an acceptable alternative to protect HCWs from splashes and sprays from procedures not likely to generate aerosols and for cleaning of rooms, although there is no evidence to support this decision.
Internationally, HCWs are falling ill with COVID-19. Data from Italy and Spain show that about 9% to 13% of these countries’ cases are HCWs.18,19 Within the US, the Ohio health department reports approximately 16% of cases are HCWs.20 It is possible that 20% of frontline HCWs will become infected.21 Evolving laboratory research shows that COVID-19 remains viable in aerosols for up to 3 hours postaerosolization, thus making aerosol transmission plausible.22 Nebulizers convert liquids into aerosols and during dispersal may potentially cause secondary inhalation of fugitive emissions.23 Since interim CDC infection control guidance is to allow only essential personnel to enter the room of patients with COVID-19, many facilities will rely on their frontline nursing staff to clean and disinfect high-touch surfaces following routine care activities.24
Achieving adequate fomite disinfection following viral aerosolization may pose a significant problem for any patient receiving scheduled doses of nebulized medications. Additionally, for personnel who clean rooms following intermittent drug nebulization while wearing PPE that includes a face mask, protection from aerosolized virus may be inadequate. Subsequently, fugitive emissions from nebulized medications may potentially contribute to both nosocomial COVID-19 transmission and viral infections in the medical staff until proven otherwise by studies conducted outside of the laboratory. Prevention of infection in the medical staff is imperative since federal health care systems cannot sustain a significant loss of its workforce.
Recommendations
We recommend that health care systems stop business as usual and adopt public health recommendations issued by Canadian and Hong Kong health care authorities for the management of suspected or confirmed COVID-19 disease.25-28 We have further clarified and expanded on these interventions. During viral pandemics, prescribers and health care systems should:
- Deprescribe nebulized therapies on medical wards and intensive care units as an infection control measure. Also avoid use in any outpatient health care setting (eg, community-based clinics, EDs, triage).
- Avoid initiation of nebulized unproven therapies (eg, n-acetylcysteine, hypertonic saline).1
- Use alternative bronchodilator formulations as appropriate (eg, oral β-2 agonist, recognizing its slower onset) before prescribing nebulized agents to patients who are uncooperative or unable to follow directions needed to use a pMDI with a spacer or have experienced a prior poor response to a pMDI with spacer (eg, OptiChamber Diamond, Philips).25,27
- Limit nebulized drug utilization (eg, bronchodilators, epoprostenol) to patients who are on mechanical ventilation and will receive nebulized therapies via a closed system or to patients housed in negative pressure hospital rooms.22 Use a viral filter (eg, Salter Labs system) to decrease the spread of infection for those receiving epoprostenol via face mask.25
- Adjust procurement practices (eg, pharmacy, logistics) to address the transition from nebulized drugs to alternatives.
- Add a safety net to the drug-ordering process by restricting new orders for nebulized therapies to the prior authorization process.27 Apply the exclusion criterion of suspected or definite COVID-19.
- Add a safety net to environmental service practices. Nursing staff should track patients who received ≥ 1 nebulizations via open (before diagnosis) or closed systems so that staff wear suitable PPE to include a N-95 mask while cleaning the room.
Conclusions
To implement the aggressive infection control guidance promulgated here, we recommend collaboration with infection control, pharmacy service (eg, prior authorization team, clinical pharmacy team, and procurement team), respiratory therapy, pulmonary and other critical care physicians, EDs, CPR committee, and other stakeholders. When making significant transitions in clinical care during a viral pandemic, guidelines must be timely, use imperative wording, and consist of easily identifiable education and/or instructions for the affected frontline staff in order to change attitudes.29 Additionally, when transitioning from nebulized bronchodilators to pMDI, educational in-services should be provided to frontline staff to avoid misconceptions regarding pMDI treatment efficacy and patients’ ability to use their pMDI with spacer.30
Acknowledgments
This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville.
1. Strickland SL, Rubin BK, Haas CF, Volsko TA, Drescher GS, O’Malley CA. AARC Clinical Practice Guideline: effectiveness of pharmacologic airway clearance therapies in hospitalized patients. Respir Care. 2015;60(7):1071-1077.
2. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2020 GOLD Report. https://goldcopd.org/gold-reports/. Accessed March 26, 2020.
3. Van Geffen WH, Douma WR, Slebos DJ, Kerstjens HAM. Bronchodilators delivered by nebulizer versus pMDI with spacer or DPI for exacerbations of COPD (Review). Cochrane Database Syst Rev. 2016;8:CD011826.
4. Global Initiative for Asthma. https://ginasthma.org/wp-content/uploads/2019/06/GINA-2019-main-report-June-2019-wms.pdf. Accessed March 26, 2020.
5. Global Initiative for Asthma. Difficult-to-treat and severe asthma in adolescent and adult patients: diagnosis and management. https://ginasthma.org/wp-content/uploads/2019/04/GINA-Severe-asthma-Pocket-Guide-v2.0-wms-1.pdf. Accessed March 26, 2020.
6. Cates CJ, Welsh EJ, Rowe BH. Holding chambers (spacers) versus nebulizers for beta-agonist treatment of acute asthma. Cochrane Database Syst Rev. 2013;9:CD000052.
7. Welsh EJ, Evans DJ, Fowler SJ, Spencer S. Interventions for bronchiectasis: an overview of Cochrane systematic reviews. Cochrane Database Syst Rev. 2015;7:CD010337.
8. Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial hypertension in adults: CHEST Guideline and Expert Panel Report. CHEST. 2014;146(2):449-475.
9. Griffiths MJD, McAuley DF, Perkins GD, et al. Guidelines on the management of acute respiratory distress syndrome. BMJ Open Resp Res. 2019;6(1):e000420.
10. McGinn K, Reichert M. A comparison of inhaled nitric oxide versus inhaled epoprostenol for acute pulmonary hypertension following cardiac surgery. Ann Pharmacother. 2016;50(1):22-26.
11. Dzierba AL, Abel EE, Buckley MS, Lat I. A review of inhaled nitric oxide and aerosolized epoprostenol in acute lung injury or acute respiratory distress syndrome. Pharmacotherapy. 2014;34(3):279-290.
12. Pleasants RA, Hess DR. Aerosol delivery devices for obstructive lung diseases. Respir Care. 2018;63(6):708-733.
13. World Health Organization. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected. https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected Accessed March 26, 2020.
14. Centers for Disease Control and Prevention. Interim clinical guidance for management of patients with confirmed coronavirus disease (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html. Revised March 7, 2020. Accessed March 26, 2020.
15. Wong RSM, Hui DS. Index patient and SARS outbreak in Hong Kong. Emerg Infect Dis. 2004;10(2):339-341.
16. Wong T-W, Lee C-K, Tam W, et al; Outbreak Study Group. Emerg Infect Dis. 2004;10(2):269-276.
17. Seto WH, Tsang D, Yung RWH, et al; Advisors of Expert SARS group of Hospital Authority. Effectiveness of precautions against droplets and contact in prevention of nosocomial transmission of severe acute respiratory syndrome (SARS). Lancet. 2003;361(9368):1519-1520.
18. Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. https://jamanetwork.com/journals/jama/fullarticle/2763401?resultClick=1. Published March 17, 2020. Accessed March 26, 2020.
19. Jones S. Spain: doctors struggle to cope as 514 die from coronavirus in a day. The Guardian. March 24, 2020. https://www.theguardian.com/world/2020/mar/24/spain-doctors-lack-protection-coronavirus-covid-19. Accessed March 27, 2020.
20. 16% of Ohio’s diagnosed COVID-19 cases are healthcare workers. https://www.wlwt.com/article/16-of-ohio-s-diagnosed-covid-19-cases-are-healthcare-workers/31930566#. Updated March 25, 2020. Accessed March 27, 2020.
21. Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30627-9/fulltext. Accessed March 27, 2020.
22. van Doremalen N, Bushmaker T, Morris DH, et al. Aerosol and surface stability of SARS-CoV-2 as Compared with SARS-CoV-1 [published online ahead of print, 2020 Mar 17]. N Engl J Med. 2020;10.1056/NEJMc2004973.
23. McGrath JA, O’Sullivan A, Bennett G, et al. Investigation of the quantity of exhaled aerosol released into the environment during nebulization. Pharmaceutics. 2019;11(2):75.
24. Centers for Disease Control and Prevention. Healthcare Infection prevention and control FAQs for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/infection-control/infection-prevention-control-faq.html. Revised March 24, 2020. Accessed March 26, 2020.
25. Practice standards of respiratory procedures: post SARS era. Use of aerosolized medications. December 2003. http://www.hkresp.com/hkts.php?page=page/hkts/detail&meid=93742. Accessed March 26, 2020.
26. Wax RS, Christian MD. Practical recommendations for critical care and anesthesiology teams caring for novel coronavirus (2019-nCoV) patients. Can J Anesth. 2020. [ePub ahead of print.]
27. Newhouse MT. RE: transmission of coronavirus by nebulizer- as serious, underappreciated risk! https://www.cmaj.ca/content/re-transmission-corona-virus-nebulizer-serious-underappreciated-risk. Accessed March 26, 2020. [ePub ahead of print.]
28. Moira C-Y. Severe acute respiratory syndrome (SARS) and healthcare workers. Int J Occup Environ Health. 2004;10(4):421-427.
29. Timen A, Hulscher MEJL, Rust L, et al. Barriers to implementing infection prevention and control guidelines during crises: experiences of health care professionals. Am J Infect Control. 2010;38(9):726-733.
30. Khoo SM, Tan LK, Said N, Lim TK. Metered-dose inhaler with spacer instead of nebulizer during the outbreak of severe acute respiratory syndrome in Singapore. Respir Care. 2009;54(7):855-860.
1. Strickland SL, Rubin BK, Haas CF, Volsko TA, Drescher GS, O’Malley CA. AARC Clinical Practice Guideline: effectiveness of pharmacologic airway clearance therapies in hospitalized patients. Respir Care. 2015;60(7):1071-1077.
2. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2020 GOLD Report. https://goldcopd.org/gold-reports/. Accessed March 26, 2020.
3. Van Geffen WH, Douma WR, Slebos DJ, Kerstjens HAM. Bronchodilators delivered by nebulizer versus pMDI with spacer or DPI for exacerbations of COPD (Review). Cochrane Database Syst Rev. 2016;8:CD011826.
4. Global Initiative for Asthma. https://ginasthma.org/wp-content/uploads/2019/06/GINA-2019-main-report-June-2019-wms.pdf. Accessed March 26, 2020.
5. Global Initiative for Asthma. Difficult-to-treat and severe asthma in adolescent and adult patients: diagnosis and management. https://ginasthma.org/wp-content/uploads/2019/04/GINA-Severe-asthma-Pocket-Guide-v2.0-wms-1.pdf. Accessed March 26, 2020.
6. Cates CJ, Welsh EJ, Rowe BH. Holding chambers (spacers) versus nebulizers for beta-agonist treatment of acute asthma. Cochrane Database Syst Rev. 2013;9:CD000052.
7. Welsh EJ, Evans DJ, Fowler SJ, Spencer S. Interventions for bronchiectasis: an overview of Cochrane systematic reviews. Cochrane Database Syst Rev. 2015;7:CD010337.
8. Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial hypertension in adults: CHEST Guideline and Expert Panel Report. CHEST. 2014;146(2):449-475.
9. Griffiths MJD, McAuley DF, Perkins GD, et al. Guidelines on the management of acute respiratory distress syndrome. BMJ Open Resp Res. 2019;6(1):e000420.
10. McGinn K, Reichert M. A comparison of inhaled nitric oxide versus inhaled epoprostenol for acute pulmonary hypertension following cardiac surgery. Ann Pharmacother. 2016;50(1):22-26.
11. Dzierba AL, Abel EE, Buckley MS, Lat I. A review of inhaled nitric oxide and aerosolized epoprostenol in acute lung injury or acute respiratory distress syndrome. Pharmacotherapy. 2014;34(3):279-290.
12. Pleasants RA, Hess DR. Aerosol delivery devices for obstructive lung diseases. Respir Care. 2018;63(6):708-733.
13. World Health Organization. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected. https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected Accessed March 26, 2020.
14. Centers for Disease Control and Prevention. Interim clinical guidance for management of patients with confirmed coronavirus disease (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html. Revised March 7, 2020. Accessed March 26, 2020.
15. Wong RSM, Hui DS. Index patient and SARS outbreak in Hong Kong. Emerg Infect Dis. 2004;10(2):339-341.
16. Wong T-W, Lee C-K, Tam W, et al; Outbreak Study Group. Emerg Infect Dis. 2004;10(2):269-276.
17. Seto WH, Tsang D, Yung RWH, et al; Advisors of Expert SARS group of Hospital Authority. Effectiveness of precautions against droplets and contact in prevention of nosocomial transmission of severe acute respiratory syndrome (SARS). Lancet. 2003;361(9368):1519-1520.
18. Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. https://jamanetwork.com/journals/jama/fullarticle/2763401?resultClick=1. Published March 17, 2020. Accessed March 26, 2020.
19. Jones S. Spain: doctors struggle to cope as 514 die from coronavirus in a day. The Guardian. March 24, 2020. https://www.theguardian.com/world/2020/mar/24/spain-doctors-lack-protection-coronavirus-covid-19. Accessed March 27, 2020.
20. 16% of Ohio’s diagnosed COVID-19 cases are healthcare workers. https://www.wlwt.com/article/16-of-ohio-s-diagnosed-covid-19-cases-are-healthcare-workers/31930566#. Updated March 25, 2020. Accessed March 27, 2020.
21. Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30627-9/fulltext. Accessed March 27, 2020.
22. van Doremalen N, Bushmaker T, Morris DH, et al. Aerosol and surface stability of SARS-CoV-2 as Compared with SARS-CoV-1 [published online ahead of print, 2020 Mar 17]. N Engl J Med. 2020;10.1056/NEJMc2004973.
23. McGrath JA, O’Sullivan A, Bennett G, et al. Investigation of the quantity of exhaled aerosol released into the environment during nebulization. Pharmaceutics. 2019;11(2):75.
24. Centers for Disease Control and Prevention. Healthcare Infection prevention and control FAQs for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/infection-control/infection-prevention-control-faq.html. Revised March 24, 2020. Accessed March 26, 2020.
25. Practice standards of respiratory procedures: post SARS era. Use of aerosolized medications. December 2003. http://www.hkresp.com/hkts.php?page=page/hkts/detail&meid=93742. Accessed March 26, 2020.
26. Wax RS, Christian MD. Practical recommendations for critical care and anesthesiology teams caring for novel coronavirus (2019-nCoV) patients. Can J Anesth. 2020. [ePub ahead of print.]
27. Newhouse MT. RE: transmission of coronavirus by nebulizer- as serious, underappreciated risk! https://www.cmaj.ca/content/re-transmission-corona-virus-nebulizer-serious-underappreciated-risk. Accessed March 26, 2020. [ePub ahead of print.]
28. Moira C-Y. Severe acute respiratory syndrome (SARS) and healthcare workers. Int J Occup Environ Health. 2004;10(4):421-427.
29. Timen A, Hulscher MEJL, Rust L, et al. Barriers to implementing infection prevention and control guidelines during crises: experiences of health care professionals. Am J Infect Control. 2010;38(9):726-733.
30. Khoo SM, Tan LK, Said N, Lim TK. Metered-dose inhaler with spacer instead of nebulizer during the outbreak of severe acute respiratory syndrome in Singapore. Respir Care. 2009;54(7):855-860.