Federal Practitioner

Learning health systems (LHS) promote a continuous process that can assist in making sense of uncertainty when confronting emerging complex conditions such as Long COVID. Long COVID is an infection-associated chronic condition that detrimentally impacts veterans, their families, and the communities in which they live. This complex condition is defined by ongoing, new, or returning symptoms following COVID-19 infection that negatively affect return to meaningful participation in social, recreational, and vocational activities.^1,2 The clinical uncertainty surrounding Long COVID is amplified by unclear etiology, prognosis, and expected course of symptoms.^3,4 Uncertainty surrounding best clinical practices, processes, and policies for Long COVID care has resulted in practice variation despite the emerging evidence base for Long COVID care.⁴ Failure to address gaps in clinical evidence and care implementation threatens to perpetuate fragmented and unnecessary care.

The context surrounding Long COVID created an urgency to rapidly address clinically relevant questions and make sense of any uncertainty. Thus, the Veterans Health Administration (VHA) funded a Long COVID Practice-Based Research Network (LC-PBRN) to build an infrastructure that supports Long COVID research nationally and promotes interdisciplinary collaboration. The LC-PBRN vision is to centralize Long COVID clinical, research, and operational activities. The research infrastructure of the LC-PBRN is designed with an LHS lens to facilitate feedback loops and integrate knowledge learned while making progress towards this vision.⁵ This article describes the phases of infrastructure development and network building, as well as associated lessons learned.

Designing the LC-PBRN Infrastructure

The LC-PBRN is a multisite operation with interdisciplinary representatives from 4 US Department of Veterans Affairs (VA) health care systems. Each site has ≥ 1 principal investigator (0.1-0.4 full-time equivalent [FTE]) and ≥ 1 project staff member (0.5-0.8 FTE). The lead site also employs data and statistical support staff (1.5 FTE). To build this infrastructure, VHA Health Services Research awarded $1 million in November 2023 to the 4 sites. The funding was distributed over 2 years. Additional funding will be required for sustainability. The components and key infrastructure elements of the LC-PBRN are outlined in the Table. The 2-year LC-PBRN implementation activities is outlined in the Appendix.

Vision

The LC-PBRN’s vision is to create an infrastructure that integrates an LHS framework by unifying the VA research approach to Long COVID to ensure veteran, clinician, operational, and researcher involvement (Figure 1). A critical aspect of this is a unifying definition of Long COVID, for which the LC-PBRN has adopted the National Academies of Science, Engineering, and Medicine (NASEM) definition: “Long COVID is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.”⁶ This is a working definition to be refined over time, as necessary, based on new data. The LC-PBRN aligns with existing VA initiatives by serving as a centralized hub for internal and external networking. This approach ensures shareholder needs are identified, resources are allocated appropriately, and redundancy in efforts is avoided. In this spirit, the LC-PBRN maintains a long-term vision of collaborating with other systems to support national efforts to address Long COVID.

Mission and Governance

The LC-PBRN operates with an executive leadership team and 5 cores. The executive leadership team is responsible for overall LC-PBRN operations, management, and direction setting of the LC-PBRN. The executive leadership team meets weekly to provide oversight of each core, which specializes in different aspects. The cores include: Administrative, Partner Engagement and Needs Assessment, Patient Identification and Analysis, Clinical Coordination and Implementation, and Dissemination (Figure 2).

The Administrative core focuses on interagency collaboration to identify and network with key operational and agency leaders to allow for ongoing exploration of funding strategies for Long COVID research. The Administrative core manages 3 teams: an advisory board, Long COVID council, and the strategic planning team. The advisory board meets biannually to oversee achievement of LC-PBRN goals, deliverables, and tactics for meeting these goals. The advisory board includes the LC-PBRN executive leadership team and 13 interagency members from various shareholders (eg, Centers for Disease Control and Prevention, National Institutes of Health, and specialty departments within the VA).

The Long COVID council convenes quarterly to provide scientific input on important overarching issues in Long COVID research, practice, and policy. The council consists of 22 scientific representatives in VA and non-VA contexts, university affiliates, and veteran representatives. The strategic planning team convenes annually to identify how the LC-PBRN and its partners can meet the needs of the broader Long COVID ecosystem and conduct a strengths, opportunities, weaknesses, and threats analysis to identify strategic objectives and expected outcomes. The strategic planning team includes the executive leadership team and key Long COVID shareholders within VHA and affiliated partners. The Partner Engagement and Needs Assessment core aims to solicit feedback from veterans, clinicians, researchers, and operational leadership. Input is gathered through a Veteran Engagement Panel and a modified Delphi consensus process. The panel was formed using a Community Engagement Studio model to engage veterans as consultants on research.⁷ Currently, 10 members represent a range of ages, genders, racial and ethnic backgrounds, and military experience. All veterans have a history of Long COVID and are paid as consultants. Video conference panel meetings occur quarterly for 1 to 2 hours; the meeting length is shorter than typical engagement studios to accommodate for fatigue-related symptoms that may limit attention and ability to participate in longer meetings. Before each panel, the Partner Engagement and Needs Assessment core helps identify key questions and creates a structured agenda. Each panel begins with a presentation of a research study followed by a group discussion led by a trained facilitator. The modified Delphi consensus process focuses on identifying research priority areas for Long COVID within the VA. Veterans living with Long COVID, as well as clinicians and researchers who work closely with patients who have Long COVID, complete a series of progressive surveys to provide input on research priorities.

The Partner Engagement and Needs Assessment core also actively provides outreach to important partners in research, clinical care, and operational leadership to facilitate introductory meetings to (1) ask partners to describe their 5 largest pain points, (2) find pain points within the scope of LC-PBRN resources, and (3) discuss the strengths and capacity of the PBRN. During introductory meetings, communications preferences and a cadence for subsequent meetings are established. Subsequent engagement meetings aim to provide updates and codevelop solutions to emerging issues. This core maintains a living document to track engagement efforts, points of contact for identified and emerging partners, and ensure all communication is timely.

The Patient Identification and Analysis core develops a database of veterans with confirmed or suspected Long COVID. The goal is for researchers to use the database to identify potential participants for clinical trials and monitor clinical care outcomes. When possible, this core works with existing VA data to facilitate research that aligns with the LC-PBRN mission. The core can also use natural language processing and machine learning to work with researchers conducting clinical trials to help identify patients who may meet eligibility criteria.

The Clinical Coordination and Implementation core gathers information on the best practices for identifying and recruiting veterans for Long COVID research as well as compiles strategies for standardized clinical assessments that can both facilitate ongoing research and the successful implementation of evidence-based care. The Clinical Coordination and Implementation core provides support to pilot and multisite trials in 3 ways. First, it develops toolkits such as best practice strategies for recruiting participants for research, template examples of recruitment materials, and a library of patient-reported outcome measures, standardized clinical note titles and templates in use for Long COVID in the national electronic health record. Second, it partners with the Patient Identification and Analysis core to facilitate access to and use of algorithms that identify Long COVID cases based on electronic health records for recruitment. Finally, it compiles a detailed list of potential collaborating sites. The steps to facilitate patient identification and recruitment inform feasibility assessments and improve efficiency of launching pilot studies and multisite trials. The library of outcome measures, standardized clinical notes, and templates can aid and expedite data collection.

The Dissemination core focuses on developing a website, creating a dissemination plan, and actively disseminating products of the LC-PBRN and its partners. This core’s foundational framework is based on the Agency for Healthcare Research and Quality Quick-Start Guide to Dissemination for PBRNs.^8,9 The core built an internal- and external-facing website to connect users with LC-PBRN products, potential outreach contacts, and promote timely updates on LC-PBRN activities. A manual of operating procedures will be drafted to include the development of training for practitioners involved in research projects to learn the processes involved in presenting clinical results for education and training initiatives, presentations, and manuscript preparation. A toolkit will also be developed to support dissemination activities designed to reach a variety of end-users, such as education materials, policy briefings, educational briefs, newsletters, and presentations at local, regional, and national levels.

Key Partners

Key partners exist specific to the LC-PBRN and within the broader VA ecosystem, including VA clinical operations, VA research, and intra-agency collaborations.

LC-PBRN Specific. In addition to the LC-PBRN council, advisory board, and Veteran Engagement Panel discussed earlier, the LC-PBRN has 8 VA Long COVID clinical sites that have joined the network. As part of the network, these sites gain greater insight into the Long COVID ecosystem within the VA through priority access to the Long COVID Veteran Engagement Panel and recognition as members of the network. The LC-PBRN also meets monthly with pilot projects conducted at other VA facilities to learn more about how Long COVID research is being implemented and identify how the LC-PBRN can assist in troubleshooting barriers.

VA Clinical Operations. To support clinical operations, a Long COVID Field Advisory Board was formed through the VA Office of Specialty Care as an operational effort to develop clinical best practice. The LC-PBRN consults with this group on veteran engagement strategies for input on clinical guides and dissemination of practice guide materials. The LC-PBRN also partners with an existing Long COVID Community of Practice and the Office of Primary Care. The Community of Practice provides a learning space for VA staff interested in advancing Long COVID care and assists with disseminating LC-PBRN to the broader Long COVID clinical community. A member of the Office of Primary Care sits on the PBRN advisory board to provide input on engaging primary care practitioners and ensure their unique needs are considered in LC-PBRN initiatives.

VA Research & Interagency Collaborations. The LC-PBRN engages monthly with an interagency workgroup led by the US Department of Health and Human Services Office of Long COVID Research and Practice. These engagements support identification of research gaps that the VA may help address, monitor emerging funding opportunities, and foster collaborations. LC-PBRN representatives also meet with staff at the National Institutes of Health Researching COVID to Enhance Recovery initiative to identify pathways for veteran recruitment.

LHS Feedback Loops

The LC-PBRN was designed with an LHS approach in mind.¹⁰ Throughout development of the LC-PBRN, consideration was given to (1) capture data on new efforts within the Long COVID ecosystem (performance to data), (2) examine performance gaps and identify approaches for best practice (data to knowledge), and (3) implement best practices, develop toolkits, disseminate findings, and measure impacts (knowledge to performance). With this approach, the LC-PBRN is constantly evolving based on new information coming from the internal and external Long COVID ecosystem. Each element was deliberatively considered in relation to how data can be transformed into knowledge, knowledge into performance, and performance into data.

First, an important mechanism for feedback involves establishing clear channels of communication. Regular check-ins with key partners occur through virtual meetings to provide updates, assess needs and challenges, and codevelop action plans. For example, during a check-in with the Long COVID Field Advisory Board, members expressed a desire to incorporate veteran feedback into VA clinical practice recommendations. We provided expertise on different engagement modalities (eg, focus groups vs individual interviews), and collaboration occurred to identify key interview questions for veterans. This process resulted in a published clinician-facing Long COVID Nervous System Clinical Guide (available at [email protected]) that integrated critical feedback from veterans related to neurological symptoms.

Second, weekly executive leadership meetings include dedicated time for reflection on partner feedback, the current state of Long COVID, and contextual changes that impact deliverable priorities and timelines. Outcomes from these discussions are communicated with VHA Health Services Research and, when appropriate, to key partners to ensure alignment. For example, the Patient Identification and Analysis core was originally tasked with identifying a definition of Long COVID. However, as the broader community moved away from a singular definition, efforts were redirected toward higher-priority issues within the VA Long COVID ecosystem, including veteran enrollment in clinical trials.

Third, the Veteran Engagement Panel captures feedback from those with lived experience to inform Long COVID research and clinical efforts. The panel meetings are strategically designed to ask veterans living with Long COVID specific questions related to a given research or clinical topic of interest. For example, panel sessions with the Field Advisory Board focused on concerns articulated by veterans related to the mental health and gastroenterological symptoms associated with Long COVID. Insights from these discussions will inform development of Long COVID mental health and gastroenterological clinical care guides, with several PBRN investigators serving as subject matter experts. This collaborative approach ensures that veteran perspectives are represented in developing Long COVID clinical care processes.

Fourth, research priorities identified through the Delphi consensus process will inform development of VA Request for Funding Proposals related to Long COVID. The initial survey was developed in collaboration with veterans, clinicians, and researchers across the Veteran Engagement Panel, the Field Advisory Board, and the National Research Action Plan on Long COVID.¹¹ The process was launched in October 2024 and concluded in June 2025. The team conducted 3 consensus rounds with veterans and VA clinicians and researchers. Top priority areas included the testing assessments for diagnosing Long COVID, studying subtypes of Long COVID and treatments for each, and finding biomarkers for Long COVID. A formal publication of the results and analysis is the focus of a future publication.

Fifth, ongoing engagement with the Field Advisory Board has supported adoption of a preliminary set of clinical outcome measures. If universally adopted, these instruments may contribute to the development of a standardized data collection process and serve as common data elements collected for epidemiologic, health services, or clinical trial research.

Lessons Learned and Practice Implications

Throughout the development of the LC-PBRN, several decisions were identified that have impacted infrastructure development and implementation.

Include veterans’ voices to ensure network efforts align with patient needs. Given the novelty of Long COVID, practitioners and researchers are learning as they go. It is important to listen to individuals who live with Long COVID. Throughout the development of the LC-PBRN, veteran perspective has proven how vital it is for them to be heard when it comes to their health care. Clinicians similarly highlighted the value of incorporating patient perspectives into the development of tools and treatment strategies. Develop an interdisciplinary leadership team to foster the diverse viewpoints needed to tackle multifaceted problems. It is important to consider as many clinical and research perspectives as possible because Long COVID is a complex condition with symptoms impacting major organ systems.^12-15 Therefore, the team spans across a multitude of specialties and locations.

Set clear expectations and goals with partners to uphold timely deliverables and stay within the PBRN’s capacity. When including a multitude of partners, teams should consider each of those partners’ experiences and opinions in decision-making conversations. Expectation setting is important to ensure all partners are on the same page and understand the capacity of the LC-PBRN. This allows the team to focus its efforts, avoid being overwhelmed with requests, and provide quality deliverables.

Build engaging relationships to bridge gaps between internal and external partners. A substantial number of resources focus on building relationships with partners so they can trust the LC-PBRN has their best interests in mind. These relationships are important to ensure the VA avoids duplicate efforts. This includes prioritizing connecting partners who are working on similar efforts to promote collaboration across facilities.

Clinical practice implications. The LC-PBRN is working towards clinical practice initiatives derived from this process in partnership with the Long COVID Community of Practice and the participating clinical sites. This may include efforts to increase the uptake of standardized instruments endorsed by clinical partners that facilitate assessment of outcomes. PBRN partners can then use outcomes data to ask and answer clinically relevant research questions and assess care quality to inform the learning process that is integral to an LHS. Future dissemination efforts will be centered around individual initiatives and deliverables from the LC-PBRN.

Conclusions

PBRNs provide an important mechanism to use LHS approaches to successfully convene research around complex issues. PBRNs can support integration across the LHS cycle, allowing for multiple feedback loops, and coordinate activities that work to achieve a larger vision. PBRNs offer centralized mechanisms to collaboratively understand and address complex problems, such as Long COVID, where the uncertainty regarding how to treat occurs in tandem with the urgency to treat. The LC-PBRN model described in this article has the potential to transcend Long COVID by building infrastructure necessary to proactively address current or future clinical conditions or populations with a LHS lens. The infrastructure can require cross-system and sector collaborations, expediency, inclusivity, and patient- and family-centeredness. Future efforts will focus on building out a larger network of VHA sites, facilitating recruitment at site and veteran levels into Long COVID trials through case identification, and systematically support the standardization of clinical data for clinical utility and evaluation of quality and/or outcomes across the VHA.

Learning health systems (LHS) promote a continuous process that can assist in making sense of uncertainty when confronting emerging complex conditions such as Long COVID. Long COVID is an infection-associated chronic condition that detrimentally impacts veterans, their families, and the communities in which they live. This complex condition is defined by ongoing, new, or returning symptoms following COVID-19 infection that negatively affect return to meaningful participation in social, recreational, and vocational activities.^1,2 The clinical uncertainty surrounding Long COVID is amplified by unclear etiology, prognosis, and expected course of symptoms.^3,4 Uncertainty surrounding best clinical practices, processes, and policies for Long COVID care has resulted in practice variation despite the emerging evidence base for Long COVID care.⁴ Failure to address gaps in clinical evidence and care implementation threatens to perpetuate fragmented and unnecessary care.

The context surrounding Long COVID created an urgency to rapidly address clinically relevant questions and make sense of any uncertainty. Thus, the Veterans Health Administration (VHA) funded a Long COVID Practice-Based Research Network (LC-PBRN) to build an infrastructure that supports Long COVID research nationally and promotes interdisciplinary collaboration. The LC-PBRN vision is to centralize Long COVID clinical, research, and operational activities. The research infrastructure of the LC-PBRN is designed with an LHS lens to facilitate feedback loops and integrate knowledge learned while making progress towards this vision.⁵ This article describes the phases of infrastructure development and network building, as well as associated lessons learned.

Designing the LC-PBRN Infrastructure

The LC-PBRN is a multisite operation with interdisciplinary representatives from 4 US Department of Veterans Affairs (VA) health care systems. Each site has ≥ 1 principal investigator (0.1-0.4 full-time equivalent [FTE]) and ≥ 1 project staff member (0.5-0.8 FTE). The lead site also employs data and statistical support staff (1.5 FTE). To build this infrastructure, VHA Health Services Research awarded $1 million in November 2023 to the 4 sites. The funding was distributed over 2 years. Additional funding will be required for sustainability. The components and key infrastructure elements of the LC-PBRN are outlined in the Table. The 2-year LC-PBRN implementation activities is outlined in the Appendix.

Vision

The LC-PBRN’s vision is to create an infrastructure that integrates an LHS framework by unifying the VA research approach to Long COVID to ensure veteran, clinician, operational, and researcher involvement (Figure 1). A critical aspect of this is a unifying definition of Long COVID, for which the LC-PBRN has adopted the National Academies of Science, Engineering, and Medicine (NASEM) definition: “Long COVID is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.”⁶ This is a working definition to be refined over time, as necessary, based on new data. The LC-PBRN aligns with existing VA initiatives by serving as a centralized hub for internal and external networking. This approach ensures shareholder needs are identified, resources are allocated appropriately, and redundancy in efforts is avoided. In this spirit, the LC-PBRN maintains a long-term vision of collaborating with other systems to support national efforts to address Long COVID.

Mission and Governance

The LC-PBRN operates with an executive leadership team and 5 cores. The executive leadership team is responsible for overall LC-PBRN operations, management, and direction setting of the LC-PBRN. The executive leadership team meets weekly to provide oversight of each core, which specializes in different aspects. The cores include: Administrative, Partner Engagement and Needs Assessment, Patient Identification and Analysis, Clinical Coordination and Implementation, and Dissemination (Figure 2).

The Administrative core focuses on interagency collaboration to identify and network with key operational and agency leaders to allow for ongoing exploration of funding strategies for Long COVID research. The Administrative core manages 3 teams: an advisory board, Long COVID council, and the strategic planning team. The advisory board meets biannually to oversee achievement of LC-PBRN goals, deliverables, and tactics for meeting these goals. The advisory board includes the LC-PBRN executive leadership team and 13 interagency members from various shareholders (eg, Centers for Disease Control and Prevention, National Institutes of Health, and specialty departments within the VA).

The Long COVID council convenes quarterly to provide scientific input on important overarching issues in Long COVID research, practice, and policy. The council consists of 22 scientific representatives in VA and non-VA contexts, university affiliates, and veteran representatives. The strategic planning team convenes annually to identify how the LC-PBRN and its partners can meet the needs of the broader Long COVID ecosystem and conduct a strengths, opportunities, weaknesses, and threats analysis to identify strategic objectives and expected outcomes. The strategic planning team includes the executive leadership team and key Long COVID shareholders within VHA and affiliated partners. The Partner Engagement and Needs Assessment core aims to solicit feedback from veterans, clinicians, researchers, and operational leadership. Input is gathered through a Veteran Engagement Panel and a modified Delphi consensus process. The panel was formed using a Community Engagement Studio model to engage veterans as consultants on research.⁷ Currently, 10 members represent a range of ages, genders, racial and ethnic backgrounds, and military experience. All veterans have a history of Long COVID and are paid as consultants. Video conference panel meetings occur quarterly for 1 to 2 hours; the meeting length is shorter than typical engagement studios to accommodate for fatigue-related symptoms that may limit attention and ability to participate in longer meetings. Before each panel, the Partner Engagement and Needs Assessment core helps identify key questions and creates a structured agenda. Each panel begins with a presentation of a research study followed by a group discussion led by a trained facilitator. The modified Delphi consensus process focuses on identifying research priority areas for Long COVID within the VA. Veterans living with Long COVID, as well as clinicians and researchers who work closely with patients who have Long COVID, complete a series of progressive surveys to provide input on research priorities.

The Partner Engagement and Needs Assessment core also actively provides outreach to important partners in research, clinical care, and operational leadership to facilitate introductory meetings to (1) ask partners to describe their 5 largest pain points, (2) find pain points within the scope of LC-PBRN resources, and (3) discuss the strengths and capacity of the PBRN. During introductory meetings, communications preferences and a cadence for subsequent meetings are established. Subsequent engagement meetings aim to provide updates and codevelop solutions to emerging issues. This core maintains a living document to track engagement efforts, points of contact for identified and emerging partners, and ensure all communication is timely.

The Patient Identification and Analysis core develops a database of veterans with confirmed or suspected Long COVID. The goal is for researchers to use the database to identify potential participants for clinical trials and monitor clinical care outcomes. When possible, this core works with existing VA data to facilitate research that aligns with the LC-PBRN mission. The core can also use natural language processing and machine learning to work with researchers conducting clinical trials to help identify patients who may meet eligibility criteria.

The Clinical Coordination and Implementation core gathers information on the best practices for identifying and recruiting veterans for Long COVID research as well as compiles strategies for standardized clinical assessments that can both facilitate ongoing research and the successful implementation of evidence-based care. The Clinical Coordination and Implementation core provides support to pilot and multisite trials in 3 ways. First, it develops toolkits such as best practice strategies for recruiting participants for research, template examples of recruitment materials, and a library of patient-reported outcome measures, standardized clinical note titles and templates in use for Long COVID in the national electronic health record. Second, it partners with the Patient Identification and Analysis core to facilitate access to and use of algorithms that identify Long COVID cases based on electronic health records for recruitment. Finally, it compiles a detailed list of potential collaborating sites. The steps to facilitate patient identification and recruitment inform feasibility assessments and improve efficiency of launching pilot studies and multisite trials. The library of outcome measures, standardized clinical notes, and templates can aid and expedite data collection.

The Dissemination core focuses on developing a website, creating a dissemination plan, and actively disseminating products of the LC-PBRN and its partners. This core’s foundational framework is based on the Agency for Healthcare Research and Quality Quick-Start Guide to Dissemination for PBRNs.^8,9 The core built an internal- and external-facing website to connect users with LC-PBRN products, potential outreach contacts, and promote timely updates on LC-PBRN activities. A manual of operating procedures will be drafted to include the development of training for practitioners involved in research projects to learn the processes involved in presenting clinical results for education and training initiatives, presentations, and manuscript preparation. A toolkit will also be developed to support dissemination activities designed to reach a variety of end-users, such as education materials, policy briefings, educational briefs, newsletters, and presentations at local, regional, and national levels.

Key Partners

Key partners exist specific to the LC-PBRN and within the broader VA ecosystem, including VA clinical operations, VA research, and intra-agency collaborations.

LC-PBRN Specific. In addition to the LC-PBRN council, advisory board, and Veteran Engagement Panel discussed earlier, the LC-PBRN has 8 VA Long COVID clinical sites that have joined the network. As part of the network, these sites gain greater insight into the Long COVID ecosystem within the VA through priority access to the Long COVID Veteran Engagement Panel and recognition as members of the network. The LC-PBRN also meets monthly with pilot projects conducted at other VA facilities to learn more about how Long COVID research is being implemented and identify how the LC-PBRN can assist in troubleshooting barriers.

VA Clinical Operations. To support clinical operations, a Long COVID Field Advisory Board was formed through the VA Office of Specialty Care as an operational effort to develop clinical best practice. The LC-PBRN consults with this group on veteran engagement strategies for input on clinical guides and dissemination of practice guide materials. The LC-PBRN also partners with an existing Long COVID Community of Practice and the Office of Primary Care. The Community of Practice provides a learning space for VA staff interested in advancing Long COVID care and assists with disseminating LC-PBRN to the broader Long COVID clinical community. A member of the Office of Primary Care sits on the PBRN advisory board to provide input on engaging primary care practitioners and ensure their unique needs are considered in LC-PBRN initiatives.

VA Research & Interagency Collaborations. The LC-PBRN engages monthly with an interagency workgroup led by the US Department of Health and Human Services Office of Long COVID Research and Practice. These engagements support identification of research gaps that the VA may help address, monitor emerging funding opportunities, and foster collaborations. LC-PBRN representatives also meet with staff at the National Institutes of Health Researching COVID to Enhance Recovery initiative to identify pathways for veteran recruitment.

LHS Feedback Loops

The LC-PBRN was designed with an LHS approach in mind.¹⁰ Throughout development of the LC-PBRN, consideration was given to (1) capture data on new efforts within the Long COVID ecosystem (performance to data), (2) examine performance gaps and identify approaches for best practice (data to knowledge), and (3) implement best practices, develop toolkits, disseminate findings, and measure impacts (knowledge to performance). With this approach, the LC-PBRN is constantly evolving based on new information coming from the internal and external Long COVID ecosystem. Each element was deliberatively considered in relation to how data can be transformed into knowledge, knowledge into performance, and performance into data.

First, an important mechanism for feedback involves establishing clear channels of communication. Regular check-ins with key partners occur through virtual meetings to provide updates, assess needs and challenges, and codevelop action plans. For example, during a check-in with the Long COVID Field Advisory Board, members expressed a desire to incorporate veteran feedback into VA clinical practice recommendations. We provided expertise on different engagement modalities (eg, focus groups vs individual interviews), and collaboration occurred to identify key interview questions for veterans. This process resulted in a published clinician-facing Long COVID Nervous System Clinical Guide (available at [email protected]) that integrated critical feedback from veterans related to neurological symptoms.

Second, weekly executive leadership meetings include dedicated time for reflection on partner feedback, the current state of Long COVID, and contextual changes that impact deliverable priorities and timelines. Outcomes from these discussions are communicated with VHA Health Services Research and, when appropriate, to key partners to ensure alignment. For example, the Patient Identification and Analysis core was originally tasked with identifying a definition of Long COVID. However, as the broader community moved away from a singular definition, efforts were redirected toward higher-priority issues within the VA Long COVID ecosystem, including veteran enrollment in clinical trials.

Third, the Veteran Engagement Panel captures feedback from those with lived experience to inform Long COVID research and clinical efforts. The panel meetings are strategically designed to ask veterans living with Long COVID specific questions related to a given research or clinical topic of interest. For example, panel sessions with the Field Advisory Board focused on concerns articulated by veterans related to the mental health and gastroenterological symptoms associated with Long COVID. Insights from these discussions will inform development of Long COVID mental health and gastroenterological clinical care guides, with several PBRN investigators serving as subject matter experts. This collaborative approach ensures that veteran perspectives are represented in developing Long COVID clinical care processes.

Fourth, research priorities identified through the Delphi consensus process will inform development of VA Request for Funding Proposals related to Long COVID. The initial survey was developed in collaboration with veterans, clinicians, and researchers across the Veteran Engagement Panel, the Field Advisory Board, and the National Research Action Plan on Long COVID.¹¹ The process was launched in October 2024 and concluded in June 2025. The team conducted 3 consensus rounds with veterans and VA clinicians and researchers. Top priority areas included the testing assessments for diagnosing Long COVID, studying subtypes of Long COVID and treatments for each, and finding biomarkers for Long COVID. A formal publication of the results and analysis is the focus of a future publication.

Fifth, ongoing engagement with the Field Advisory Board has supported adoption of a preliminary set of clinical outcome measures. If universally adopted, these instruments may contribute to the development of a standardized data collection process and serve as common data elements collected for epidemiologic, health services, or clinical trial research.

Lessons Learned and Practice Implications

Throughout the development of the LC-PBRN, several decisions were identified that have impacted infrastructure development and implementation.

Include veterans’ voices to ensure network efforts align with patient needs. Given the novelty of Long COVID, practitioners and researchers are learning as they go. It is important to listen to individuals who live with Long COVID. Throughout the development of the LC-PBRN, veteran perspective has proven how vital it is for them to be heard when it comes to their health care. Clinicians similarly highlighted the value of incorporating patient perspectives into the development of tools and treatment strategies. Develop an interdisciplinary leadership team to foster the diverse viewpoints needed to tackle multifaceted problems. It is important to consider as many clinical and research perspectives as possible because Long COVID is a complex condition with symptoms impacting major organ systems.^12-15 Therefore, the team spans across a multitude of specialties and locations.

Set clear expectations and goals with partners to uphold timely deliverables and stay within the PBRN’s capacity. When including a multitude of partners, teams should consider each of those partners’ experiences and opinions in decision-making conversations. Expectation setting is important to ensure all partners are on the same page and understand the capacity of the LC-PBRN. This allows the team to focus its efforts, avoid being overwhelmed with requests, and provide quality deliverables.

Build engaging relationships to bridge gaps between internal and external partners. A substantial number of resources focus on building relationships with partners so they can trust the LC-PBRN has their best interests in mind. These relationships are important to ensure the VA avoids duplicate efforts. This includes prioritizing connecting partners who are working on similar efforts to promote collaboration across facilities.

Clinical practice implications. The LC-PBRN is working towards clinical practice initiatives derived from this process in partnership with the Long COVID Community of Practice and the participating clinical sites. This may include efforts to increase the uptake of standardized instruments endorsed by clinical partners that facilitate assessment of outcomes. PBRN partners can then use outcomes data to ask and answer clinically relevant research questions and assess care quality to inform the learning process that is integral to an LHS. Future dissemination efforts will be centered around individual initiatives and deliverables from the LC-PBRN.

Conclusions

PBRNs provide an important mechanism to use LHS approaches to successfully convene research around complex issues. PBRNs can support integration across the LHS cycle, allowing for multiple feedback loops, and coordinate activities that work to achieve a larger vision. PBRNs offer centralized mechanisms to collaboratively understand and address complex problems, such as Long COVID, where the uncertainty regarding how to treat occurs in tandem with the urgency to treat. The LC-PBRN model described in this article has the potential to transcend Long COVID by building infrastructure necessary to proactively address current or future clinical conditions or populations with a LHS lens. The infrastructure can require cross-system and sector collaborations, expediency, inclusivity, and patient- and family-centeredness. Future efforts will focus on building out a larger network of VHA sites, facilitating recruitment at site and veteran levels into Long COVID trials through case identification, and systematically support the standardization of clinical data for clinical utility and evaluation of quality and/or outcomes across the VHA.

Learning health systems (LHS) promote a continuous process that can assist in making sense of uncertainty when confronting emerging complex conditions such as Long COVID. Long COVID is an infection-associated chronic condition that detrimentally impacts veterans, their families, and the communities in which they live. This complex condition is defined by ongoing, new, or returning symptoms following COVID-19 infection that negatively affect return to meaningful participation in social, recreational, and vocational activities.^1,2 The clinical uncertainty surrounding Long COVID is amplified by unclear etiology, prognosis, and expected course of symptoms.^3,4 Uncertainty surrounding best clinical practices, processes, and policies for Long COVID care has resulted in practice variation despite the emerging evidence base for Long COVID care.⁴ Failure to address gaps in clinical evidence and care implementation threatens to perpetuate fragmented and unnecessary care.

The context surrounding Long COVID created an urgency to rapidly address clinically relevant questions and make sense of any uncertainty. Thus, the Veterans Health Administration (VHA) funded a Long COVID Practice-Based Research Network (LC-PBRN) to build an infrastructure that supports Long COVID research nationally and promotes interdisciplinary collaboration. The LC-PBRN vision is to centralize Long COVID clinical, research, and operational activities. The research infrastructure of the LC-PBRN is designed with an LHS lens to facilitate feedback loops and integrate knowledge learned while making progress towards this vision.⁵ This article describes the phases of infrastructure development and network building, as well as associated lessons learned.

Designing the LC-PBRN Infrastructure

The LC-PBRN is a multisite operation with interdisciplinary representatives from 4 US Department of Veterans Affairs (VA) health care systems. Each site has ≥ 1 principal investigator (0.1-0.4 full-time equivalent [FTE]) and ≥ 1 project staff member (0.5-0.8 FTE). The lead site also employs data and statistical support staff (1.5 FTE). To build this infrastructure, VHA Health Services Research awarded $1 million in November 2023 to the 4 sites. The funding was distributed over 2 years. Additional funding will be required for sustainability. The components and key infrastructure elements of the LC-PBRN are outlined in the Table. The 2-year LC-PBRN implementation activities is outlined in the Appendix.

Vision

The LC-PBRN’s vision is to create an infrastructure that integrates an LHS framework by unifying the VA research approach to Long COVID to ensure veteran, clinician, operational, and researcher involvement (Figure 1). A critical aspect of this is a unifying definition of Long COVID, for which the LC-PBRN has adopted the National Academies of Science, Engineering, and Medicine (NASEM) definition: “Long COVID is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.”⁶ This is a working definition to be refined over time, as necessary, based on new data. The LC-PBRN aligns with existing VA initiatives by serving as a centralized hub for internal and external networking. This approach ensures shareholder needs are identified, resources are allocated appropriately, and redundancy in efforts is avoided. In this spirit, the LC-PBRN maintains a long-term vision of collaborating with other systems to support national efforts to address Long COVID.

Mission and Governance

The LC-PBRN operates with an executive leadership team and 5 cores. The executive leadership team is responsible for overall LC-PBRN operations, management, and direction setting of the LC-PBRN. The executive leadership team meets weekly to provide oversight of each core, which specializes in different aspects. The cores include: Administrative, Partner Engagement and Needs Assessment, Patient Identification and Analysis, Clinical Coordination and Implementation, and Dissemination (Figure 2).

The Administrative core focuses on interagency collaboration to identify and network with key operational and agency leaders to allow for ongoing exploration of funding strategies for Long COVID research. The Administrative core manages 3 teams: an advisory board, Long COVID council, and the strategic planning team. The advisory board meets biannually to oversee achievement of LC-PBRN goals, deliverables, and tactics for meeting these goals. The advisory board includes the LC-PBRN executive leadership team and 13 interagency members from various shareholders (eg, Centers for Disease Control and Prevention, National Institutes of Health, and specialty departments within the VA).

The Long COVID council convenes quarterly to provide scientific input on important overarching issues in Long COVID research, practice, and policy. The council consists of 22 scientific representatives in VA and non-VA contexts, university affiliates, and veteran representatives. The strategic planning team convenes annually to identify how the LC-PBRN and its partners can meet the needs of the broader Long COVID ecosystem and conduct a strengths, opportunities, weaknesses, and threats analysis to identify strategic objectives and expected outcomes. The strategic planning team includes the executive leadership team and key Long COVID shareholders within VHA and affiliated partners. The Partner Engagement and Needs Assessment core aims to solicit feedback from veterans, clinicians, researchers, and operational leadership. Input is gathered through a Veteran Engagement Panel and a modified Delphi consensus process. The panel was formed using a Community Engagement Studio model to engage veterans as consultants on research.⁷ Currently, 10 members represent a range of ages, genders, racial and ethnic backgrounds, and military experience. All veterans have a history of Long COVID and are paid as consultants. Video conference panel meetings occur quarterly for 1 to 2 hours; the meeting length is shorter than typical engagement studios to accommodate for fatigue-related symptoms that may limit attention and ability to participate in longer meetings. Before each panel, the Partner Engagement and Needs Assessment core helps identify key questions and creates a structured agenda. Each panel begins with a presentation of a research study followed by a group discussion led by a trained facilitator. The modified Delphi consensus process focuses on identifying research priority areas for Long COVID within the VA. Veterans living with Long COVID, as well as clinicians and researchers who work closely with patients who have Long COVID, complete a series of progressive surveys to provide input on research priorities.

The Partner Engagement and Needs Assessment core also actively provides outreach to important partners in research, clinical care, and operational leadership to facilitate introductory meetings to (1) ask partners to describe their 5 largest pain points, (2) find pain points within the scope of LC-PBRN resources, and (3) discuss the strengths and capacity of the PBRN. During introductory meetings, communications preferences and a cadence for subsequent meetings are established. Subsequent engagement meetings aim to provide updates and codevelop solutions to emerging issues. This core maintains a living document to track engagement efforts, points of contact for identified and emerging partners, and ensure all communication is timely.

The Patient Identification and Analysis core develops a database of veterans with confirmed or suspected Long COVID. The goal is for researchers to use the database to identify potential participants for clinical trials and monitor clinical care outcomes. When possible, this core works with existing VA data to facilitate research that aligns with the LC-PBRN mission. The core can also use natural language processing and machine learning to work with researchers conducting clinical trials to help identify patients who may meet eligibility criteria.

The Clinical Coordination and Implementation core gathers information on the best practices for identifying and recruiting veterans for Long COVID research as well as compiles strategies for standardized clinical assessments that can both facilitate ongoing research and the successful implementation of evidence-based care. The Clinical Coordination and Implementation core provides support to pilot and multisite trials in 3 ways. First, it develops toolkits such as best practice strategies for recruiting participants for research, template examples of recruitment materials, and a library of patient-reported outcome measures, standardized clinical note titles and templates in use for Long COVID in the national electronic health record. Second, it partners with the Patient Identification and Analysis core to facilitate access to and use of algorithms that identify Long COVID cases based on electronic health records for recruitment. Finally, it compiles a detailed list of potential collaborating sites. The steps to facilitate patient identification and recruitment inform feasibility assessments and improve efficiency of launching pilot studies and multisite trials. The library of outcome measures, standardized clinical notes, and templates can aid and expedite data collection.

The Dissemination core focuses on developing a website, creating a dissemination plan, and actively disseminating products of the LC-PBRN and its partners. This core’s foundational framework is based on the Agency for Healthcare Research and Quality Quick-Start Guide to Dissemination for PBRNs.^8,9 The core built an internal- and external-facing website to connect users with LC-PBRN products, potential outreach contacts, and promote timely updates on LC-PBRN activities. A manual of operating procedures will be drafted to include the development of training for practitioners involved in research projects to learn the processes involved in presenting clinical results for education and training initiatives, presentations, and manuscript preparation. A toolkit will also be developed to support dissemination activities designed to reach a variety of end-users, such as education materials, policy briefings, educational briefs, newsletters, and presentations at local, regional, and national levels.

Key Partners

Key partners exist specific to the LC-PBRN and within the broader VA ecosystem, including VA clinical operations, VA research, and intra-agency collaborations.

LC-PBRN Specific. In addition to the LC-PBRN council, advisory board, and Veteran Engagement Panel discussed earlier, the LC-PBRN has 8 VA Long COVID clinical sites that have joined the network. As part of the network, these sites gain greater insight into the Long COVID ecosystem within the VA through priority access to the Long COVID Veteran Engagement Panel and recognition as members of the network. The LC-PBRN also meets monthly with pilot projects conducted at other VA facilities to learn more about how Long COVID research is being implemented and identify how the LC-PBRN can assist in troubleshooting barriers.

VA Clinical Operations. To support clinical operations, a Long COVID Field Advisory Board was formed through the VA Office of Specialty Care as an operational effort to develop clinical best practice. The LC-PBRN consults with this group on veteran engagement strategies for input on clinical guides and dissemination of practice guide materials. The LC-PBRN also partners with an existing Long COVID Community of Practice and the Office of Primary Care. The Community of Practice provides a learning space for VA staff interested in advancing Long COVID care and assists with disseminating LC-PBRN to the broader Long COVID clinical community. A member of the Office of Primary Care sits on the PBRN advisory board to provide input on engaging primary care practitioners and ensure their unique needs are considered in LC-PBRN initiatives.

VA Research & Interagency Collaborations. The LC-PBRN engages monthly with an interagency workgroup led by the US Department of Health and Human Services Office of Long COVID Research and Practice. These engagements support identification of research gaps that the VA may help address, monitor emerging funding opportunities, and foster collaborations. LC-PBRN representatives also meet with staff at the National Institutes of Health Researching COVID to Enhance Recovery initiative to identify pathways for veteran recruitment.

LHS Feedback Loops

The LC-PBRN was designed with an LHS approach in mind.¹⁰ Throughout development of the LC-PBRN, consideration was given to (1) capture data on new efforts within the Long COVID ecosystem (performance to data), (2) examine performance gaps and identify approaches for best practice (data to knowledge), and (3) implement best practices, develop toolkits, disseminate findings, and measure impacts (knowledge to performance). With this approach, the LC-PBRN is constantly evolving based on new information coming from the internal and external Long COVID ecosystem. Each element was deliberatively considered in relation to how data can be transformed into knowledge, knowledge into performance, and performance into data.

First, an important mechanism for feedback involves establishing clear channels of communication. Regular check-ins with key partners occur through virtual meetings to provide updates, assess needs and challenges, and codevelop action plans. For example, during a check-in with the Long COVID Field Advisory Board, members expressed a desire to incorporate veteran feedback into VA clinical practice recommendations. We provided expertise on different engagement modalities (eg, focus groups vs individual interviews), and collaboration occurred to identify key interview questions for veterans. This process resulted in a published clinician-facing Long COVID Nervous System Clinical Guide (available at [email protected]) that integrated critical feedback from veterans related to neurological symptoms.

Second, weekly executive leadership meetings include dedicated time for reflection on partner feedback, the current state of Long COVID, and contextual changes that impact deliverable priorities and timelines. Outcomes from these discussions are communicated with VHA Health Services Research and, when appropriate, to key partners to ensure alignment. For example, the Patient Identification and Analysis core was originally tasked with identifying a definition of Long COVID. However, as the broader community moved away from a singular definition, efforts were redirected toward higher-priority issues within the VA Long COVID ecosystem, including veteran enrollment in clinical trials.

Third, the Veteran Engagement Panel captures feedback from those with lived experience to inform Long COVID research and clinical efforts. The panel meetings are strategically designed to ask veterans living with Long COVID specific questions related to a given research or clinical topic of interest. For example, panel sessions with the Field Advisory Board focused on concerns articulated by veterans related to the mental health and gastroenterological symptoms associated with Long COVID. Insights from these discussions will inform development of Long COVID mental health and gastroenterological clinical care guides, with several PBRN investigators serving as subject matter experts. This collaborative approach ensures that veteran perspectives are represented in developing Long COVID clinical care processes.

Fourth, research priorities identified through the Delphi consensus process will inform development of VA Request for Funding Proposals related to Long COVID. The initial survey was developed in collaboration with veterans, clinicians, and researchers across the Veteran Engagement Panel, the Field Advisory Board, and the National Research Action Plan on Long COVID.¹¹ The process was launched in October 2024 and concluded in June 2025. The team conducted 3 consensus rounds with veterans and VA clinicians and researchers. Top priority areas included the testing assessments for diagnosing Long COVID, studying subtypes of Long COVID and treatments for each, and finding biomarkers for Long COVID. A formal publication of the results and analysis is the focus of a future publication.

Fifth, ongoing engagement with the Field Advisory Board has supported adoption of a preliminary set of clinical outcome measures. If universally adopted, these instruments may contribute to the development of a standardized data collection process and serve as common data elements collected for epidemiologic, health services, or clinical trial research.

Lessons Learned and Practice Implications

Throughout the development of the LC-PBRN, several decisions were identified that have impacted infrastructure development and implementation.

Include veterans’ voices to ensure network efforts align with patient needs. Given the novelty of Long COVID, practitioners and researchers are learning as they go. It is important to listen to individuals who live with Long COVID. Throughout the development of the LC-PBRN, veteran perspective has proven how vital it is for them to be heard when it comes to their health care. Clinicians similarly highlighted the value of incorporating patient perspectives into the development of tools and treatment strategies. Develop an interdisciplinary leadership team to foster the diverse viewpoints needed to tackle multifaceted problems. It is important to consider as many clinical and research perspectives as possible because Long COVID is a complex condition with symptoms impacting major organ systems.^12-15 Therefore, the team spans across a multitude of specialties and locations.

Set clear expectations and goals with partners to uphold timely deliverables and stay within the PBRN’s capacity. When including a multitude of partners, teams should consider each of those partners’ experiences and opinions in decision-making conversations. Expectation setting is important to ensure all partners are on the same page and understand the capacity of the LC-PBRN. This allows the team to focus its efforts, avoid being overwhelmed with requests, and provide quality deliverables.

Build engaging relationships to bridge gaps between internal and external partners. A substantial number of resources focus on building relationships with partners so they can trust the LC-PBRN has their best interests in mind. These relationships are important to ensure the VA avoids duplicate efforts. This includes prioritizing connecting partners who are working on similar efforts to promote collaboration across facilities.

Clinical practice implications. The LC-PBRN is working towards clinical practice initiatives derived from this process in partnership with the Long COVID Community of Practice and the participating clinical sites. This may include efforts to increase the uptake of standardized instruments endorsed by clinical partners that facilitate assessment of outcomes. PBRN partners can then use outcomes data to ask and answer clinically relevant research questions and assess care quality to inform the learning process that is integral to an LHS. Future dissemination efforts will be centered around individual initiatives and deliverables from the LC-PBRN.

Conclusions

PBRNs provide an important mechanism to use LHS approaches to successfully convene research around complex issues. PBRNs can support integration across the LHS cycle, allowing for multiple feedback loops, and coordinate activities that work to achieve a larger vision. PBRNs offer centralized mechanisms to collaboratively understand and address complex problems, such as Long COVID, where the uncertainty regarding how to treat occurs in tandem with the urgency to treat. The LC-PBRN model described in this article has the potential to transcend Long COVID by building infrastructure necessary to proactively address current or future clinical conditions or populations with a LHS lens. The infrastructure can require cross-system and sector collaborations, expediency, inclusivity, and patient- and family-centeredness. Future efforts will focus on building out a larger network of VHA sites, facilitating recruitment at site and veteran levels into Long COVID trials through case identification, and systematically support the standardization of clinical data for clinical utility and evaluation of quality and/or outcomes across the VHA.

TOPLINE:

Among patients with ulcerative colitis (UC) who develop colorectal cancer (CRC), greater background mucosal inflammation at the time of CRC diagnosis is associated with progressively worse survival outcomes, with tumors arising within the UC-involved segment having worse prognosis.

METHODOLOGY:

• Patients with UC are at an increased risk for CRC, with risk influenced by the extent and intensity of underlying mucosal inflammation.
• Researchers retrospectively reviewed medical records of patients with UC diagnosed with CRC between 1983 and 2020 at 43 institutions across Japan to determine whether inflammation at cancer diagnosis affected prognosis.
• After endoscopic assessment, tumors were classified as arising inside the UC‑involved segment at diagnosis (within‑area tumors) or outside that segment (outside‑area tumors).
• The Mayo endoscopic score (MES) was used to grade background mucosal inflammation in the within‑area group as inactive (MES 0), mild-moderate (MES 1-2), or severe (MES 3).
• The primary endpoint was 5-year recurrence-free survival, and the secondary endpoint was 5-year cancer-specific survival.

TAKEAWAY:

• Among 723 patients followed for a median of 51 months, 683 had within-area tumors (mean age at CRC diagnosis, 51.8 years; 61.9% male) and 40 had outside-area tumors (mean age at CRC diagnosis, 61.1 years; 60.0% male).
• The within-area group had lower rate of 5-year recurrence-free survival than the outside-area group (75.1% vs 87.6%; P = .022), and lower rate of 5-year cancer-specific survival (81.1% vs 94.3%; P = .038).
• Within-area tumor location independently predicted worse recurrence-free survival (adjusted hazard ratio, 2.99; P = .030).
• In the within‑area group, higher MES was associated with stepwise (although nonsignificant) declines in recurrence‑free survival (inactive, 84.4%; mild-moderate, 79.4%; severe, 73.8%; P = .150). Corresponding cancer‑specific survival rates in these groups declined significantly (89.0%, 84.8%, and 73.8%, respectively; P = .048).

IN PRACTICE:

“These findings shift the clinical focus from inflammation as a risk factor for carcinogenesis to inflammation as a prognostic determinant, highlighting a potential new role for systematic endoscopic assessment of the background mucosa at cancer diagnosis,” the authors wrote.

SOURCE:

This study was led by Akiyoshi Ikebata, Department of Surgery, Keio University School of Medicine, Tokyo, Japan. It was published online in December 2025, in the Journal of Crohn's and Colitis.

LIMITATIONS:

The retrospective design introduced potential for unmeasured confounding and selection bias. The MES was assigned by local physicians without central review, which may have introduced variability. The small size of the outside‑area tumor group increased the risk for baseline imbalances.

DISCLOSURES:

No specific funding source was reported. The authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Among patients with ulcerative colitis (UC) who develop colorectal cancer (CRC), greater background mucosal inflammation at the time of CRC diagnosis is associated with progressively worse survival outcomes, with tumors arising within the UC-involved segment having worse prognosis.

METHODOLOGY:

• Patients with UC are at an increased risk for CRC, with risk influenced by the extent and intensity of underlying mucosal inflammation.
• Researchers retrospectively reviewed medical records of patients with UC diagnosed with CRC between 1983 and 2020 at 43 institutions across Japan to determine whether inflammation at cancer diagnosis affected prognosis.
• After endoscopic assessment, tumors were classified as arising inside the UC‑involved segment at diagnosis (within‑area tumors) or outside that segment (outside‑area tumors).
• The Mayo endoscopic score (MES) was used to grade background mucosal inflammation in the within‑area group as inactive (MES 0), mild-moderate (MES 1-2), or severe (MES 3).
• The primary endpoint was 5-year recurrence-free survival, and the secondary endpoint was 5-year cancer-specific survival.

TAKEAWAY:

• Among 723 patients followed for a median of 51 months, 683 had within-area tumors (mean age at CRC diagnosis, 51.8 years; 61.9% male) and 40 had outside-area tumors (mean age at CRC diagnosis, 61.1 years; 60.0% male).
• The within-area group had lower rate of 5-year recurrence-free survival than the outside-area group (75.1% vs 87.6%; P = .022), and lower rate of 5-year cancer-specific survival (81.1% vs 94.3%; P = .038).
• Within-area tumor location independently predicted worse recurrence-free survival (adjusted hazard ratio, 2.99; P = .030).
• In the within‑area group, higher MES was associated with stepwise (although nonsignificant) declines in recurrence‑free survival (inactive, 84.4%; mild-moderate, 79.4%; severe, 73.8%; P = .150). Corresponding cancer‑specific survival rates in these groups declined significantly (89.0%, 84.8%, and 73.8%, respectively; P = .048).

IN PRACTICE:

“These findings shift the clinical focus from inflammation as a risk factor for carcinogenesis to inflammation as a prognostic determinant, highlighting a potential new role for systematic endoscopic assessment of the background mucosa at cancer diagnosis,” the authors wrote.

SOURCE:

This study was led by Akiyoshi Ikebata, Department of Surgery, Keio University School of Medicine, Tokyo, Japan. It was published online in December 2025, in the Journal of Crohn's and Colitis.

LIMITATIONS:

The retrospective design introduced potential for unmeasured confounding and selection bias. The MES was assigned by local physicians without central review, which may have introduced variability. The small size of the outside‑area tumor group increased the risk for baseline imbalances.

DISCLOSURES:

No specific funding source was reported. The authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Among patients with ulcerative colitis (UC) who develop colorectal cancer (CRC), greater background mucosal inflammation at the time of CRC diagnosis is associated with progressively worse survival outcomes, with tumors arising within the UC-involved segment having worse prognosis.

METHODOLOGY:

• Patients with UC are at an increased risk for CRC, with risk influenced by the extent and intensity of underlying mucosal inflammation.
• Researchers retrospectively reviewed medical records of patients with UC diagnosed with CRC between 1983 and 2020 at 43 institutions across Japan to determine whether inflammation at cancer diagnosis affected prognosis.
• After endoscopic assessment, tumors were classified as arising inside the UC‑involved segment at diagnosis (within‑area tumors) or outside that segment (outside‑area tumors).
• The Mayo endoscopic score (MES) was used to grade background mucosal inflammation in the within‑area group as inactive (MES 0), mild-moderate (MES 1-2), or severe (MES 3).
• The primary endpoint was 5-year recurrence-free survival, and the secondary endpoint was 5-year cancer-specific survival.

TAKEAWAY:

• Among 723 patients followed for a median of 51 months, 683 had within-area tumors (mean age at CRC diagnosis, 51.8 years; 61.9% male) and 40 had outside-area tumors (mean age at CRC diagnosis, 61.1 years; 60.0% male).
• The within-area group had lower rate of 5-year recurrence-free survival than the outside-area group (75.1% vs 87.6%; P = .022), and lower rate of 5-year cancer-specific survival (81.1% vs 94.3%; P = .038).
• Within-area tumor location independently predicted worse recurrence-free survival (adjusted hazard ratio, 2.99; P = .030).
• In the within‑area group, higher MES was associated with stepwise (although nonsignificant) declines in recurrence‑free survival (inactive, 84.4%; mild-moderate, 79.4%; severe, 73.8%; P = .150). Corresponding cancer‑specific survival rates in these groups declined significantly (89.0%, 84.8%, and 73.8%, respectively; P = .048).

IN PRACTICE:

“These findings shift the clinical focus from inflammation as a risk factor for carcinogenesis to inflammation as a prognostic determinant, highlighting a potential new role for systematic endoscopic assessment of the background mucosa at cancer diagnosis,” the authors wrote.

SOURCE:

This study was led by Akiyoshi Ikebata, Department of Surgery, Keio University School of Medicine, Tokyo, Japan. It was published online in December 2025, in the Journal of Crohn's and Colitis.

LIMITATIONS:

The retrospective design introduced potential for unmeasured confounding and selection bias. The MES was assigned by local physicians without central review, which may have introduced variability. The small size of the outside‑area tumor group increased the risk for baseline imbalances.

DISCLOSURES:

No specific funding source was reported. The authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Among patients with high-risk malignant colorectal polyps, 19% had residual disease, with rates of 25% in the immediate surgery group vs 9% in the nonoperative management group. The rate of rectum and sphincter preservation in the nonoperative surveillance group was over 90%, and all recurrences were successfully treated with salvage surgery or chemoradiotherapy.

METHODOLOGY:

• Although guidelines in the US recommend colorectal resection when a malignant colorectal polyp has high-risk features, some patients choose nonoperative management instead to avoid the associated averse effects and impact on quality of life. The safety of nonoperative management, however, remains unclear.
• A single-center cohort study conducted between 2015 and 2022 included 336 patients who underwent polypectomy in the colon (n = 226) or rectum (n = 110) and had at least one high-risk feature. High-risk features included positive margins, piecemeal resection with unclear margin, lymphovascular invasion, perineural invasion, poor differentiation, and tumor budding.
• The analysis compared rates of residual disease between those who had immediate surgery (62%) and nonoperative management (38%) following the removal of a malignant polyp, 15% of whom (n = 19) received systemic chemotherapy after polypectomy.
• Researchers also assessed the rates of distant metastasis between the two groups and the association between specific high-risk features and residual disease or post-treatment complications.

TAKEAWAY:

• In the overall population, 19% of patients had residual disease (63 of 336). Among the 208 patients who had immediate surgery, 25% (n = 51) had residual disease, including 9% (n = 19) with residual disease in the bowel wall and 19% (n = 39) in locoregional lymph nodes. Postoperative complications occurred in 12% of patients (n = 25) in the immediate surgery group, with 3% (n = 7) having complications considered grade 3 or higher.
• Among the 128 patients who received nonoperative surveillance, 9% (n = 12) developed recurrence during surveillance, 6% (n = 7) in the bowel wall and 4% (n = 5) in locoregional lymph nodes. All recurrences in the nonoperative surveillance group were successfully treated with either salvage surgery (n = 6) or chemoradiotherapy (n = 6).
• Among patients in the nonoperative group with a malignant polyp removed from the rectum, the rate of rectum preservation was 94% (74 of 79 patients); the sphincter preservation rate was 91% for tumors < 5 cm from the anal verge.
• Distant metastases occurred in 2% of all patients across both groups.

IN PRACTICE:

"The risk of residual disease after the removal of a malignant colorectal polyp with [high-risk features] is considerable, but nonoperative management offers the potential for organ preservation, with the availability of effective salvage options if rectal cancer is detected," the authors of the study concluded.

SOURCE:

The study, led by Thikhamporn Tawantanakorn, MD, and Martin R. Weiser, MD, of Memorial Sloan Kettering Cancer Center in New York City, was published online in JCO Oncology Advances.

LIMITATIONS:

The researchers noted several limitations, including variable follow-up among patients and challenges in assessing polypectomy histology, particularly after piecemeal resection, which limited evaluation of certain high-risk features such as tumor budding. Additionally, as the study was conducted at a specialized cancer center with dedicated gastrointestinal pathology and radiology services and readily available office endoscopy, the results may not be fully generalizable to less specialized centers.

DISCLOSURES:

Jinru Shia, MD, reported receiving consulting fees from Paige.AI and research funding through their institution. Andrea Cercek, MD, disclosed consulting roles with multiple pharmaceutical companies, including GlaxoSmithKline, Incyte, Merck, and others, as well as research funding from GlaxoSmithKline and Pfizer. Weiser reported receiving royalties as a section editor for UpToDate. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Among patients with high-risk malignant colorectal polyps, 19% had residual disease, with rates of 25% in the immediate surgery group vs 9% in the nonoperative management group. The rate of rectum and sphincter preservation in the nonoperative surveillance group was over 90%, and all recurrences were successfully treated with salvage surgery or chemoradiotherapy.

METHODOLOGY:

• Although guidelines in the US recommend colorectal resection when a malignant colorectal polyp has high-risk features, some patients choose nonoperative management instead to avoid the associated averse effects and impact on quality of life. The safety of nonoperative management, however, remains unclear.
• A single-center cohort study conducted between 2015 and 2022 included 336 patients who underwent polypectomy in the colon (n = 226) or rectum (n = 110) and had at least one high-risk feature. High-risk features included positive margins, piecemeal resection with unclear margin, lymphovascular invasion, perineural invasion, poor differentiation, and tumor budding.
• The analysis compared rates of residual disease between those who had immediate surgery (62%) and nonoperative management (38%) following the removal of a malignant polyp, 15% of whom (n = 19) received systemic chemotherapy after polypectomy.
• Researchers also assessed the rates of distant metastasis between the two groups and the association between specific high-risk features and residual disease or post-treatment complications.

TAKEAWAY:

• In the overall population, 19% of patients had residual disease (63 of 336). Among the 208 patients who had immediate surgery, 25% (n = 51) had residual disease, including 9% (n = 19) with residual disease in the bowel wall and 19% (n = 39) in locoregional lymph nodes. Postoperative complications occurred in 12% of patients (n = 25) in the immediate surgery group, with 3% (n = 7) having complications considered grade 3 or higher.
• Among the 128 patients who received nonoperative surveillance, 9% (n = 12) developed recurrence during surveillance, 6% (n = 7) in the bowel wall and 4% (n = 5) in locoregional lymph nodes. All recurrences in the nonoperative surveillance group were successfully treated with either salvage surgery (n = 6) or chemoradiotherapy (n = 6).
• Among patients in the nonoperative group with a malignant polyp removed from the rectum, the rate of rectum preservation was 94% (74 of 79 patients); the sphincter preservation rate was 91% for tumors < 5 cm from the anal verge.
• Distant metastases occurred in 2% of all patients across both groups.

IN PRACTICE:

"The risk of residual disease after the removal of a malignant colorectal polyp with [high-risk features] is considerable, but nonoperative management offers the potential for organ preservation, with the availability of effective salvage options if rectal cancer is detected," the authors of the study concluded.

SOURCE:

The study, led by Thikhamporn Tawantanakorn, MD, and Martin R. Weiser, MD, of Memorial Sloan Kettering Cancer Center in New York City, was published online in JCO Oncology Advances.

LIMITATIONS:

The researchers noted several limitations, including variable follow-up among patients and challenges in assessing polypectomy histology, particularly after piecemeal resection, which limited evaluation of certain high-risk features such as tumor budding. Additionally, as the study was conducted at a specialized cancer center with dedicated gastrointestinal pathology and radiology services and readily available office endoscopy, the results may not be fully generalizable to less specialized centers.

DISCLOSURES:

Jinru Shia, MD, reported receiving consulting fees from Paige.AI and research funding through their institution. Andrea Cercek, MD, disclosed consulting roles with multiple pharmaceutical companies, including GlaxoSmithKline, Incyte, Merck, and others, as well as research funding from GlaxoSmithKline and Pfizer. Weiser reported receiving royalties as a section editor for UpToDate. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Among patients with high-risk malignant colorectal polyps, 19% had residual disease, with rates of 25% in the immediate surgery group vs 9% in the nonoperative management group. The rate of rectum and sphincter preservation in the nonoperative surveillance group was over 90%, and all recurrences were successfully treated with salvage surgery or chemoradiotherapy.

METHODOLOGY:

• Although guidelines in the US recommend colorectal resection when a malignant colorectal polyp has high-risk features, some patients choose nonoperative management instead to avoid the associated averse effects and impact on quality of life. The safety of nonoperative management, however, remains unclear.
• A single-center cohort study conducted between 2015 and 2022 included 336 patients who underwent polypectomy in the colon (n = 226) or rectum (n = 110) and had at least one high-risk feature. High-risk features included positive margins, piecemeal resection with unclear margin, lymphovascular invasion, perineural invasion, poor differentiation, and tumor budding.
• The analysis compared rates of residual disease between those who had immediate surgery (62%) and nonoperative management (38%) following the removal of a malignant polyp, 15% of whom (n = 19) received systemic chemotherapy after polypectomy.
• Researchers also assessed the rates of distant metastasis between the two groups and the association between specific high-risk features and residual disease or post-treatment complications.

TAKEAWAY:

• In the overall population, 19% of patients had residual disease (63 of 336). Among the 208 patients who had immediate surgery, 25% (n = 51) had residual disease, including 9% (n = 19) with residual disease in the bowel wall and 19% (n = 39) in locoregional lymph nodes. Postoperative complications occurred in 12% of patients (n = 25) in the immediate surgery group, with 3% (n = 7) having complications considered grade 3 or higher.
• Among the 128 patients who received nonoperative surveillance, 9% (n = 12) developed recurrence during surveillance, 6% (n = 7) in the bowel wall and 4% (n = 5) in locoregional lymph nodes. All recurrences in the nonoperative surveillance group were successfully treated with either salvage surgery (n = 6) or chemoradiotherapy (n = 6).
• Among patients in the nonoperative group with a malignant polyp removed from the rectum, the rate of rectum preservation was 94% (74 of 79 patients); the sphincter preservation rate was 91% for tumors < 5 cm from the anal verge.
• Distant metastases occurred in 2% of all patients across both groups.

IN PRACTICE:

"The risk of residual disease after the removal of a malignant colorectal polyp with [high-risk features] is considerable, but nonoperative management offers the potential for organ preservation, with the availability of effective salvage options if rectal cancer is detected," the authors of the study concluded.

SOURCE:

The study, led by Thikhamporn Tawantanakorn, MD, and Martin R. Weiser, MD, of Memorial Sloan Kettering Cancer Center in New York City, was published online in JCO Oncology Advances.

LIMITATIONS:

The researchers noted several limitations, including variable follow-up among patients and challenges in assessing polypectomy histology, particularly after piecemeal resection, which limited evaluation of certain high-risk features such as tumor budding. Additionally, as the study was conducted at a specialized cancer center with dedicated gastrointestinal pathology and radiology services and readily available office endoscopy, the results may not be fully generalizable to less specialized centers.

DISCLOSURES:

Jinru Shia, MD, reported receiving consulting fees from Paige.AI and research funding through their institution. Andrea Cercek, MD, disclosed consulting roles with multiple pharmaceutical companies, including GlaxoSmithKline, Incyte, Merck, and others, as well as research funding from GlaxoSmithKline and Pfizer. Weiser reported receiving royalties as a section editor for UpToDate. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.

Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.

SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”

Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.

The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.

Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”

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

The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.

Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.

SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”

Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.

The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.

Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”

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

The FDA has granted accelerated approval for a subcutaneous (SC) formulation of mosunetuzumab (Lunsumio VELO, Roche) for the treatment of certain adults with relapsed or refractory follicular lymphoma.

Specifically, the CD20 × CD3 bispecific antibody — which was initially approved as an intravenous (IV) formulation and was the first of its kind approved for relapsed or refractory follicular lymphoma after at least 2 prior lines of therapy — is now approved for SC administration in the same setting, according to a Roche press release.

SC delivery reduces treatment time to about 1 minute compared with the 2–4 hours required with IV infusion. Like the IV formulation, the SC version can be administered in the outpatient setting and is a fixed-duration treatment given for a defined period, Roche noted, adding that “[b]y contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.”

Full approval, which may be contingent on verification of benefit in a confirmatory trial, was based on findings from the phase 1/2 G029781 study of both IV and SC formulations in patients with relapsed or refractory non–Hodgkin lymphoma, including follicular lymphoma.

The objective response rate and complete response rate with SC formulation were 75% and 59%, respectively. The median duration of response was 22.4 months.

Adverse reactions occurring in at least 20% of patients were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), SARS–CoV–2 infection, musculoskeletal pain, and diarrhea. CRS occurred in 30% of patients. Most of those events were low-grade, and all resolved after a median of 2 days.

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” stated Ian Flinn, MD, PhD, of Tennessee Oncology and OneOncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”

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

TOPLINE:

Rural cancer survivors experience significantly higher rates of chronic pain at 43.0% than those among urban survivors at 33.5%. Even after controlling for demographics and health conditions, rural residents showed 21% higher odds of experiencing chronic pain.

METHODOLOGY:

• Chronic pain prevalence among cancer survivors is twice that of the general US population and is associated with numerous negative outcomes. Rural residence is frequently linked to debilitating long-term survivorship effects, and current data lack information on whether chronic pain disparity exists specifically for rural cancer survivors.
• Researchers pooled data from the 2019–2021 and 2023 National Health Interview Survey, a cross–sectional survey conducted by the National Center for Health Statistics.
• Analysis included 5542 adult cancer survivors diagnosed within the previous 5 years, with 51.6% female participants and 48.4% male participants.
• Chronic pain was defined as pain experienced on most or all days over the past 3 months, following National Center for Health Statistics conventions.
• Rural residence classification was based on noncore or nonmetropolitan counties using the modified National Center for Health Statistics Urban–Rural Classification Scheme for Counties.

TAKEAWAY:

• Rural cancer survivors showed significantly higher odds of experiencing chronic pain compared with urban survivors (odds ratio [OR], 1.21; 95% CI, 1.01-1.45).
• Rural survivors were more likely to be non–Hispanic White, have less than a 4-year college degree, have an income below 200% of the federal poverty level, and have slightly more chronic health conditions.
• Having an income below 100% of the federal poverty level was associated with doubled odds of chronic pain (OR, 2.07; 95% CI, 1.54-2.77) compared with having an income at least four times the federal poverty level.
• Each additional health condition increased the odds of experiencing chronic pain by 32% (OR, 1.32; 95% CI, 1.26-1.39).

IN PRACTICE:

“Policymakers and health systems should work to close this gap by increasing the availability of pain management resources for rural cancer survivors. Approaches could include innovative payment models for integrative medicine in rural areas or supporting rural clinician access to pain specialists,” the authors of the study wrote.

SOURCE:

This study was led by Hyojin Choi, PhD, Department of Family Medicine, The Robert Larner MD College of Medicine, University of Vermont in Burlington, Vermont. It was published online in JAMA Network Open.

LIMITATIONS:

The authors note that the cross–sectional design of the study and limited information on individual respondents’ use of multimodal pain treatment options constrain the interpretation of findings.

DISCLOSURES:

The authors did not report any relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Rural cancer survivors experience significantly higher rates of chronic pain at 43.0% than those among urban survivors at 33.5%. Even after controlling for demographics and health conditions, rural residents showed 21% higher odds of experiencing chronic pain.

METHODOLOGY:

• Chronic pain prevalence among cancer survivors is twice that of the general US population and is associated with numerous negative outcomes. Rural residence is frequently linked to debilitating long-term survivorship effects, and current data lack information on whether chronic pain disparity exists specifically for rural cancer survivors.
• Researchers pooled data from the 2019–2021 and 2023 National Health Interview Survey, a cross–sectional survey conducted by the National Center for Health Statistics.
• Analysis included 5542 adult cancer survivors diagnosed within the previous 5 years, with 51.6% female participants and 48.4% male participants.
• Chronic pain was defined as pain experienced on most or all days over the past 3 months, following National Center for Health Statistics conventions.
• Rural residence classification was based on noncore or nonmetropolitan counties using the modified National Center for Health Statistics Urban–Rural Classification Scheme for Counties.

TAKEAWAY:

• Rural cancer survivors showed significantly higher odds of experiencing chronic pain compared with urban survivors (odds ratio [OR], 1.21; 95% CI, 1.01-1.45).
• Rural survivors were more likely to be non–Hispanic White, have less than a 4-year college degree, have an income below 200% of the federal poverty level, and have slightly more chronic health conditions.
• Having an income below 100% of the federal poverty level was associated with doubled odds of chronic pain (OR, 2.07; 95% CI, 1.54-2.77) compared with having an income at least four times the federal poverty level.
• Each additional health condition increased the odds of experiencing chronic pain by 32% (OR, 1.32; 95% CI, 1.26-1.39).

IN PRACTICE:

“Policymakers and health systems should work to close this gap by increasing the availability of pain management resources for rural cancer survivors. Approaches could include innovative payment models for integrative medicine in rural areas or supporting rural clinician access to pain specialists,” the authors of the study wrote.

SOURCE:

This study was led by Hyojin Choi, PhD, Department of Family Medicine, The Robert Larner MD College of Medicine, University of Vermont in Burlington, Vermont. It was published online in JAMA Network Open.

LIMITATIONS:

The authors note that the cross–sectional design of the study and limited information on individual respondents’ use of multimodal pain treatment options constrain the interpretation of findings.

DISCLOSURES:

The authors did not report any relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Rural cancer survivors experience significantly higher rates of chronic pain at 43.0% than those among urban survivors at 33.5%. Even after controlling for demographics and health conditions, rural residents showed 21% higher odds of experiencing chronic pain.

METHODOLOGY:

• Chronic pain prevalence among cancer survivors is twice that of the general US population and is associated with numerous negative outcomes. Rural residence is frequently linked to debilitating long-term survivorship effects, and current data lack information on whether chronic pain disparity exists specifically for rural cancer survivors.
• Researchers pooled data from the 2019–2021 and 2023 National Health Interview Survey, a cross–sectional survey conducted by the National Center for Health Statistics.
• Analysis included 5542 adult cancer survivors diagnosed within the previous 5 years, with 51.6% female participants and 48.4% male participants.
• Chronic pain was defined as pain experienced on most or all days over the past 3 months, following National Center for Health Statistics conventions.
• Rural residence classification was based on noncore or nonmetropolitan counties using the modified National Center for Health Statistics Urban–Rural Classification Scheme for Counties.

TAKEAWAY:

• Rural cancer survivors showed significantly higher odds of experiencing chronic pain compared with urban survivors (odds ratio [OR], 1.21; 95% CI, 1.01-1.45).
• Rural survivors were more likely to be non–Hispanic White, have less than a 4-year college degree, have an income below 200% of the federal poverty level, and have slightly more chronic health conditions.
• Having an income below 100% of the federal poverty level was associated with doubled odds of chronic pain (OR, 2.07; 95% CI, 1.54-2.77) compared with having an income at least four times the federal poverty level.
• Each additional health condition increased the odds of experiencing chronic pain by 32% (OR, 1.32; 95% CI, 1.26-1.39).

IN PRACTICE:

“Policymakers and health systems should work to close this gap by increasing the availability of pain management resources for rural cancer survivors. Approaches could include innovative payment models for integrative medicine in rural areas or supporting rural clinician access to pain specialists,” the authors of the study wrote.

SOURCE:

This study was led by Hyojin Choi, PhD, Department of Family Medicine, The Robert Larner MD College of Medicine, University of Vermont in Burlington, Vermont. It was published online in JAMA Network Open.

LIMITATIONS:

The authors note that the cross–sectional design of the study and limited information on individual respondents’ use of multimodal pain treatment options constrain the interpretation of findings.

DISCLOSURES:

The authors did not report any relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Emergency department (ED) visits by veterans for low-acuity conditions declined following the US Department of Veterans Affairs (VA) virtual care expansion in March 2020 and remained 12% below the baseline rate through February 2023.

METHODOLOGY:

• Researchers conducted a retrospective cross-sectional analysis using data from the VA Corporate Data Warehouse, including 10,364,893 ED visits (54.3% low-acuity visits) by about 2.6 million veterans (mean age, 60.8 years; 89.6% men; 63.7% White individuals) between March 2017 and February 2023.
• They evaluated the impact of the virtual care expansion — defined as the transition to virtual visits, including telephone and video care — which was implemented from March to May 2020, and assessed outcomes through that period.
• The primary outcome was the change in monthly counts of low-acuity visits to VA EDs, assessed using an interrupted time series analysis. The analysis focused on two intervention points: March 2020 (the start of the pandemic and virtual care scale-up) and May 2020 (when virtual care plateaued).
• A secondary analysis assessed the characteristics of ED users with low-acuity visits before and after the virtual care expansion, using 2 years of data — baseline pre-expansion year 3 (March 2019 to February 2020) and post-expansion year 3 (March 2022 to February 2023).

TAKEAWAY:

• Low-acuity ED utilization dropped by 24,514 visits (P < .001) in March 2020, followed by a modest increase of 7863 visits per month (P = .047) after May 2020, but remained 12.4% below the baseline rate by the end of February 2023.
• High-acuity visits showed similar patterns, with an initial decrease of 22,197 visits in March 2020 (P < .001) and a subsequent increase of 4180 visits per month in the post-expansion period (P = .05).
• Increased virtual care utilization was not significantly associated with reduced ED use for selected low-acuity conditions. The largest relative reductions were observed for major depression (42.4%), gastroenteritis (38.3%), and conjunctivitis (35.6%), whereas the largest absolute reductions occurred in low back pain, knee pain, and cellulitis.
• ED users with low-acuity ED visits in the post-expansion period were more likely to have 100% VA service connection (20.2% vs 14.6%), less medically complex (mean Elixhauser comorbidity score, 3.8 vs 4.2), and more likely to be classified as highly disabled (55.0% vs 48.1%) compared with those in the pre-expansion period.

IN PRACTICE:

“In this national, cross-sectional study, low-acuity ED utilization declined after the VA’s expansion of virtual care. While shifting low-acuity care away from ED settings toward virtual options may improve the value and efficiency of services, questions remain about the effects on quality and patient satisfaction,” the authors wrote. “Further research should be directed at exploring patient- and system-level factors that influence care-seeking decisions for low-acuity conditions,” they added.

SOURCE:

The study was led by Anu Ramachandran, MD, MPH, VA Palo Alto Health Care System, Menlo Park, California. It was published online on JAMA Network Open.

LIMITATIONS:

The classification of visits as low acuity in this study was based on International Classification of Diseases, Tenth Revision codes and discharge disposition; this classification did not imply inappropriate ED use as factors such as symptom severity, medical comorbidities, and access to care — which can influence care-seeking decisions — were not captured. The study did not assess all potential alternatives, including VA Urgent Care centers. Additionally, although virtual care use increased as ED visits declined, the models did not provide evidence of direct substitution.

DISCLOSURES:

The study received support from grants from the Department of VA, Veterans Health Administration, Office of Health Systems Research and Development. One author reported receiving research support through Department of VA Office of Health Systems Research and Development interagency agreement, whereas another reported receiving grant support from the VA Health Services Research program and being employed by the Veterans Affairs during the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Emergency department (ED) visits by veterans for low-acuity conditions declined following the US Department of Veterans Affairs (VA) virtual care expansion in March 2020 and remained 12% below the baseline rate through February 2023.

METHODOLOGY:

• Researchers conducted a retrospective cross-sectional analysis using data from the VA Corporate Data Warehouse, including 10,364,893 ED visits (54.3% low-acuity visits) by about 2.6 million veterans (mean age, 60.8 years; 89.6% men; 63.7% White individuals) between March 2017 and February 2023.
• They evaluated the impact of the virtual care expansion — defined as the transition to virtual visits, including telephone and video care — which was implemented from March to May 2020, and assessed outcomes through that period.
• The primary outcome was the change in monthly counts of low-acuity visits to VA EDs, assessed using an interrupted time series analysis. The analysis focused on two intervention points: March 2020 (the start of the pandemic and virtual care scale-up) and May 2020 (when virtual care plateaued).
• A secondary analysis assessed the characteristics of ED users with low-acuity visits before and after the virtual care expansion, using 2 years of data — baseline pre-expansion year 3 (March 2019 to February 2020) and post-expansion year 3 (March 2022 to February 2023).

TAKEAWAY:

• Low-acuity ED utilization dropped by 24,514 visits (P < .001) in March 2020, followed by a modest increase of 7863 visits per month (P = .047) after May 2020, but remained 12.4% below the baseline rate by the end of February 2023.
• High-acuity visits showed similar patterns, with an initial decrease of 22,197 visits in March 2020 (P < .001) and a subsequent increase of 4180 visits per month in the post-expansion period (P = .05).
• Increased virtual care utilization was not significantly associated with reduced ED use for selected low-acuity conditions. The largest relative reductions were observed for major depression (42.4%), gastroenteritis (38.3%), and conjunctivitis (35.6%), whereas the largest absolute reductions occurred in low back pain, knee pain, and cellulitis.
• ED users with low-acuity ED visits in the post-expansion period were more likely to have 100% VA service connection (20.2% vs 14.6%), less medically complex (mean Elixhauser comorbidity score, 3.8 vs 4.2), and more likely to be classified as highly disabled (55.0% vs 48.1%) compared with those in the pre-expansion period.

IN PRACTICE:

“In this national, cross-sectional study, low-acuity ED utilization declined after the VA’s expansion of virtual care. While shifting low-acuity care away from ED settings toward virtual options may improve the value and efficiency of services, questions remain about the effects on quality and patient satisfaction,” the authors wrote. “Further research should be directed at exploring patient- and system-level factors that influence care-seeking decisions for low-acuity conditions,” they added.

SOURCE:

The study was led by Anu Ramachandran, MD, MPH, VA Palo Alto Health Care System, Menlo Park, California. It was published online on JAMA Network Open.

LIMITATIONS:

The classification of visits as low acuity in this study was based on International Classification of Diseases, Tenth Revision codes and discharge disposition; this classification did not imply inappropriate ED use as factors such as symptom severity, medical comorbidities, and access to care — which can influence care-seeking decisions — were not captured. The study did not assess all potential alternatives, including VA Urgent Care centers. Additionally, although virtual care use increased as ED visits declined, the models did not provide evidence of direct substitution.

DISCLOSURES:

The study received support from grants from the Department of VA, Veterans Health Administration, Office of Health Systems Research and Development. One author reported receiving research support through Department of VA Office of Health Systems Research and Development interagency agreement, whereas another reported receiving grant support from the VA Health Services Research program and being employed by the Veterans Affairs during the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Emergency department (ED) visits by veterans for low-acuity conditions declined following the US Department of Veterans Affairs (VA) virtual care expansion in March 2020 and remained 12% below the baseline rate through February 2023.

METHODOLOGY:

• Researchers conducted a retrospective cross-sectional analysis using data from the VA Corporate Data Warehouse, including 10,364,893 ED visits (54.3% low-acuity visits) by about 2.6 million veterans (mean age, 60.8 years; 89.6% men; 63.7% White individuals) between March 2017 and February 2023.
• They evaluated the impact of the virtual care expansion — defined as the transition to virtual visits, including telephone and video care — which was implemented from March to May 2020, and assessed outcomes through that period.
• The primary outcome was the change in monthly counts of low-acuity visits to VA EDs, assessed using an interrupted time series analysis. The analysis focused on two intervention points: March 2020 (the start of the pandemic and virtual care scale-up) and May 2020 (when virtual care plateaued).
• A secondary analysis assessed the characteristics of ED users with low-acuity visits before and after the virtual care expansion, using 2 years of data — baseline pre-expansion year 3 (March 2019 to February 2020) and post-expansion year 3 (March 2022 to February 2023).

TAKEAWAY:

• Low-acuity ED utilization dropped by 24,514 visits (P < .001) in March 2020, followed by a modest increase of 7863 visits per month (P = .047) after May 2020, but remained 12.4% below the baseline rate by the end of February 2023.
• High-acuity visits showed similar patterns, with an initial decrease of 22,197 visits in March 2020 (P < .001) and a subsequent increase of 4180 visits per month in the post-expansion period (P = .05).
• Increased virtual care utilization was not significantly associated with reduced ED use for selected low-acuity conditions. The largest relative reductions were observed for major depression (42.4%), gastroenteritis (38.3%), and conjunctivitis (35.6%), whereas the largest absolute reductions occurred in low back pain, knee pain, and cellulitis.
• ED users with low-acuity ED visits in the post-expansion period were more likely to have 100% VA service connection (20.2% vs 14.6%), less medically complex (mean Elixhauser comorbidity score, 3.8 vs 4.2), and more likely to be classified as highly disabled (55.0% vs 48.1%) compared with those in the pre-expansion period.

IN PRACTICE:

“In this national, cross-sectional study, low-acuity ED utilization declined after the VA’s expansion of virtual care. While shifting low-acuity care away from ED settings toward virtual options may improve the value and efficiency of services, questions remain about the effects on quality and patient satisfaction,” the authors wrote. “Further research should be directed at exploring patient- and system-level factors that influence care-seeking decisions for low-acuity conditions,” they added.

SOURCE:

The study was led by Anu Ramachandran, MD, MPH, VA Palo Alto Health Care System, Menlo Park, California. It was published online on JAMA Network Open.

LIMITATIONS:

The classification of visits as low acuity in this study was based on International Classification of Diseases, Tenth Revision codes and discharge disposition; this classification did not imply inappropriate ED use as factors such as symptom severity, medical comorbidities, and access to care — which can influence care-seeking decisions — were not captured. The study did not assess all potential alternatives, including VA Urgent Care centers. Additionally, although virtual care use increased as ED visits declined, the models did not provide evidence of direct substitution.

DISCLOSURES:

The study received support from grants from the Department of VA, Veterans Health Administration, Office of Health Systems Research and Development. One author reported receiving research support through Department of VA Office of Health Systems Research and Development interagency agreement, whereas another reported receiving grant support from the VA Health Services Research program and being employed by the Veterans Affairs during the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Veterans received a diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) a median of 490 days after heart failure (HF) diagnosis. Those who had atrial fibrillation, coronary artery disease, or chronic kidney disease experienced longer diagnostic delays, whereas older or Black patients experienced shorter delays.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from the US Veterans Health Administration to quantify the time from HF diagnosis to ATTR-CM diagnosis and identify predictors of delays in diagnosis.
• They included veterans with HF and incident ATTR-CM diagnosed between 2016 and 2022; these veterans were identified using an algorithm based on diagnoses and medications.
• The final analysis included 2557 veterans, with a median age of 80.5 years; 99.5% were men, and 56.3% were White individuals.
• Assessments captured the time from the first HF diagnosis, the first outpatient prescription for a loop diuretic, and the first hospitalization for HF to the first ATTR-CM diagnosis, along with demographics and comorbidities.
• The primary outcome was the number of days from incident HF diagnosis to incident ATTR-CM diagnosis; a delay of > 6 months was considered meaningful.

TAKEAWAY:

• The median time from HF diagnosis to ATTR-CM diagnosis was 490 days. Overall, 65% of veterans experienced diagnostic delays > 6 months, and > 25% had delays longer than 3 years.
• Factors associated with a shorter time to ATTR-CM diagnosis included Black race (adjusted odds ratio [aOR], 0.71; 95% CI, 0.57-0.88) and older age (aOR per 10 years, 0.66; 95% CI, 0.59-0.73).
• The likelihood of longer diagnostic delays was higher in patients with coronary artery disease (aOR, 1.38; 95% CI, 1.15-1.64) and chronic kidney disease (aOR, 1.79; 95% CI, 1.50-2.15). Those with atrial fibrillation were more likely to have longer delays, although the lower bound of 95% CI was borderline (aOR, 1.21; 95% CI, 1.00-1.45).
• Among veterans with prior prescriptions of loop diuretics, the median time from the first prescription to ATTR-CM diagnosis was 835 days. Among those with a prior hospitalization for HF, the median time from hospitalization to ATTR-CM diagnosis was 300 days.

IN PRACTICE:

“This study supports the need for increased testing for ATTR-CM, thorough evaluation of cardiomyopathy etiologies at the time of HF diagnosis, and the need for new interventions that shorten the diagnostic delay in ATTR-CM,” the researchers reported.

SOURCE:

This study was led by Gabriela Spencer-Bonilla, MD, MSc, of Stanford University School of Medicine in Stanford, California. It was published online on JACC .

LIMITATIONS:

The analysis was limited to veterans engaged long enough for diagnoses of both HF and ATTR-CM. The findings may not be generalized to women given the predominantly male cohort. Echocardiography and ATTR subtype or genetic data were unavailable.

DISCLOSURES:

This study received funding from AstraZeneca. Four authors reported being the employees and stockholders of AstraZeneca. Several authors reported receiving research funding, consulting fees, and/or having equity in multiple pharmaceutical and healthcare companies, including Novo Nordisk, Bridge Bio, and Pfizer. Two authors reported receiving support from the American Heart Association, with one of them also receiving support from the National Institutes of Health.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Veterans received a diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) a median of 490 days after heart failure (HF) diagnosis. Those who had atrial fibrillation, coronary artery disease, or chronic kidney disease experienced longer diagnostic delays, whereas older or Black patients experienced shorter delays.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from the US Veterans Health Administration to quantify the time from HF diagnosis to ATTR-CM diagnosis and identify predictors of delays in diagnosis.
• They included veterans with HF and incident ATTR-CM diagnosed between 2016 and 2022; these veterans were identified using an algorithm based on diagnoses and medications.
• The final analysis included 2557 veterans, with a median age of 80.5 years; 99.5% were men, and 56.3% were White individuals.
• Assessments captured the time from the first HF diagnosis, the first outpatient prescription for a loop diuretic, and the first hospitalization for HF to the first ATTR-CM diagnosis, along with demographics and comorbidities.
• The primary outcome was the number of days from incident HF diagnosis to incident ATTR-CM diagnosis; a delay of > 6 months was considered meaningful.

TAKEAWAY:

• The median time from HF diagnosis to ATTR-CM diagnosis was 490 days. Overall, 65% of veterans experienced diagnostic delays > 6 months, and > 25% had delays longer than 3 years.
• Factors associated with a shorter time to ATTR-CM diagnosis included Black race (adjusted odds ratio [aOR], 0.71; 95% CI, 0.57-0.88) and older age (aOR per 10 years, 0.66; 95% CI, 0.59-0.73).
• The likelihood of longer diagnostic delays was higher in patients with coronary artery disease (aOR, 1.38; 95% CI, 1.15-1.64) and chronic kidney disease (aOR, 1.79; 95% CI, 1.50-2.15). Those with atrial fibrillation were more likely to have longer delays, although the lower bound of 95% CI was borderline (aOR, 1.21; 95% CI, 1.00-1.45).
• Among veterans with prior prescriptions of loop diuretics, the median time from the first prescription to ATTR-CM diagnosis was 835 days. Among those with a prior hospitalization for HF, the median time from hospitalization to ATTR-CM diagnosis was 300 days.

IN PRACTICE:

“This study supports the need for increased testing for ATTR-CM, thorough evaluation of cardiomyopathy etiologies at the time of HF diagnosis, and the need for new interventions that shorten the diagnostic delay in ATTR-CM,” the researchers reported.

SOURCE:

This study was led by Gabriela Spencer-Bonilla, MD, MSc, of Stanford University School of Medicine in Stanford, California. It was published online on JACC .

LIMITATIONS:

The analysis was limited to veterans engaged long enough for diagnoses of both HF and ATTR-CM. The findings may not be generalized to women given the predominantly male cohort. Echocardiography and ATTR subtype or genetic data were unavailable.

DISCLOSURES:

This study received funding from AstraZeneca. Four authors reported being the employees and stockholders of AstraZeneca. Several authors reported receiving research funding, consulting fees, and/or having equity in multiple pharmaceutical and healthcare companies, including Novo Nordisk, Bridge Bio, and Pfizer. Two authors reported receiving support from the American Heart Association, with one of them also receiving support from the National Institutes of Health.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Veterans received a diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) a median of 490 days after heart failure (HF) diagnosis. Those who had atrial fibrillation, coronary artery disease, or chronic kidney disease experienced longer diagnostic delays, whereas older or Black patients experienced shorter delays.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from the US Veterans Health Administration to quantify the time from HF diagnosis to ATTR-CM diagnosis and identify predictors of delays in diagnosis.
• They included veterans with HF and incident ATTR-CM diagnosed between 2016 and 2022; these veterans were identified using an algorithm based on diagnoses and medications.
• The final analysis included 2557 veterans, with a median age of 80.5 years; 99.5% were men, and 56.3% were White individuals.
• Assessments captured the time from the first HF diagnosis, the first outpatient prescription for a loop diuretic, and the first hospitalization for HF to the first ATTR-CM diagnosis, along with demographics and comorbidities.
• The primary outcome was the number of days from incident HF diagnosis to incident ATTR-CM diagnosis; a delay of > 6 months was considered meaningful.

TAKEAWAY:

• The median time from HF diagnosis to ATTR-CM diagnosis was 490 days. Overall, 65% of veterans experienced diagnostic delays > 6 months, and > 25% had delays longer than 3 years.
• Factors associated with a shorter time to ATTR-CM diagnosis included Black race (adjusted odds ratio [aOR], 0.71; 95% CI, 0.57-0.88) and older age (aOR per 10 years, 0.66; 95% CI, 0.59-0.73).
• The likelihood of longer diagnostic delays was higher in patients with coronary artery disease (aOR, 1.38; 95% CI, 1.15-1.64) and chronic kidney disease (aOR, 1.79; 95% CI, 1.50-2.15). Those with atrial fibrillation were more likely to have longer delays, although the lower bound of 95% CI was borderline (aOR, 1.21; 95% CI, 1.00-1.45).
• Among veterans with prior prescriptions of loop diuretics, the median time from the first prescription to ATTR-CM diagnosis was 835 days. Among those with a prior hospitalization for HF, the median time from hospitalization to ATTR-CM diagnosis was 300 days.

IN PRACTICE:

“This study supports the need for increased testing for ATTR-CM, thorough evaluation of cardiomyopathy etiologies at the time of HF diagnosis, and the need for new interventions that shorten the diagnostic delay in ATTR-CM,” the researchers reported.

SOURCE:

This study was led by Gabriela Spencer-Bonilla, MD, MSc, of Stanford University School of Medicine in Stanford, California. It was published online on JACC .

LIMITATIONS:

The analysis was limited to veterans engaged long enough for diagnoses of both HF and ATTR-CM. The findings may not be generalized to women given the predominantly male cohort. Echocardiography and ATTR subtype or genetic data were unavailable.

DISCLOSURES:

This study received funding from AstraZeneca. Four authors reported being the employees and stockholders of AstraZeneca. Several authors reported receiving research funding, consulting fees, and/or having equity in multiple pharmaceutical and healthcare companies, including Novo Nordisk, Bridge Bio, and Pfizer. Two authors reported receiving support from the American Heart Association, with one of them also receiving support from the National Institutes of Health.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

To see what is in front of one’s nose needs a constant struggle.
George Orwell (1946)¹

In 2019, the Veterans Health Administration (VHA) initiated a process to become a high reliability organization (HRO).² The COVID-19 pandemic has been described in medical literature as a volatile, uncertain, complex, and ambiguous (VUCA) event, underscoring the necessity of resilient communication strategies.³ Challenges posed by 2024 Hurricanes Helene and Milton further highlighted the need for resilient communication strategies within HRO implementation.

Central to the HRO journey within the VHA has been the development of tiered huddles, an evolution of the safety huddle concept.⁴ Emerging organically as an effective communication mechanism across multiple facilities between 2019 and 2020, tiered huddles were, in part, spurred by the onset of COVID-19. Tiered huddles represent a proactive approach to identifying and addressing organizational threats in their early stages, thereby preventing their escalation to a VUCA-laden crisis.⁵ When conditions evolve beyond the horizon of tractability, where challenges are easily identified and resolved, tiered huddles serve as a resilient mechanism to restore dynamic equilibrium within the organization.^6,7

This article describes how tiered huddles were integrated within Veterans Integrated Service Network (VISN) 4 and explores why these huddles are essential, particularly in the context of VUCA events. What began as a local-level tactic has now gained widespread acceptance and continues to evolve across the VHA with full support from the US Department of Veterans Affairs (VA) Under Secretary for Health.⁸

The VHA is divided into 18 VISNs. Nine VA Medical Centers (VAMCs) and 46 outpatient clinics across Pennsylvania, Delaware, and parts of Ohio, New York, and New Jersey make up VISN 4. Disseminating vital information across VISN 4, in addition to the 17 other VISNs—including 170 VAMCs and 1193 clinics—presents a formidable challenge. As the largest integrated system in the US, the VHA is realigning its workforce to address organizational inefficiencies. An enterprise of this scale, shaped by recurrent organizational change, faces ongoing challenges in sustaining clear communication across all levels. These transitions create uncertainty for staff as roles and resources shift, underscoring the need for dependable vertical and horizontal information flow. Tiered huddles offer a steady means to support coordinated communication and strengthen the system’s ability to adapt.⁹

ERIE VA MEDICAL CENTER HRO JOURNEY

In 2019, John Gennaro, the Erie VAMC executive director, attended a presentation that showcased the Cleveland Clinic’s tiered huddle process, with an opportunity to observe its 5-tiered system.¹⁰ Erie VAMC already had a 3-tiered huddle system, but the Cleveland Clinic’s more robust model inspired Gennaro to propose a VISN 4 pilot program. Tiered huddles were perceived as innovative, yet not fully embraced within the VHA; nonetheless, VISN 4, much like several other VISNs, moved forward and established a VISN-level (Tier 4) huddle.⁸ It is important to note that there was a notional fifth-tier capability as VISN and program office leaders already participated in daily VHA-wide meetings under the auspices of the Hospital Operations Center (HOC).

Expanding the Tiered Huddle Process

The Erie VAMC huddle process begins with the unit level Managers and Frontline Staff (Tier 1), then moves to Service Chiefs and Managers (Tier 2). Tier 3 involves facility executive leadership team and service chiefs, clinical directors and top VAMC administrators (these configurations may vary depending on context). The sequencing and flow of information is bidirectional across levels, reflecting the importance of closed-loop communication to ensure staff at all levels understand that issues raised are followed up on and/or closed out (Figure 1).²

Tier 4 composition may vary among VISNs depending on size and unique mission requirements.^8,11 The VISN 4 Tier 4 huddle includes the VISN director, 9 VAMC directors, and key network administrators and clinical experts. The Tier 5 huddle includes 18 VISN 4 directors with the VHA HOC (Figure 2). The tiered huddle process emphasizes team-based culture and psychological safety.^12-15 Staff at all levels are encouraged to identify and transparently resolve issues, fostering a proactive and problem-solving environment across the organization. A more nuanced and detailed process across tier levels is depicted in the Table.

The vetting and distillation of information can present challenges as vital information ascends and spreads across organization levels. Visual management systems (VMS), whether a whiteboard or a digital platform, are key to facilitate decision-making related to what needs to be prioritized and disseminated at each tier level.^2,8 At Tier 5, the HOC uses a digital VMS to provide a structured, user-friendly format for categorizing issues and topics and enhances clarity and accessibility (Figure 3). The Tier 5 VMS also facilitates tracking and reciprocal information exchange, helping to close the loop on emerging issues by monitoring their progression and resolution up and across tiers.^2,8 The Tier 5 huddle process and technology supporting continue to evolve offering increasing sophistication in organizational situational awareness and responsiveness.

VUCA: A Lens for Health Care Challenges

First introduced by social scientists at the US Army War College in 1995, VUCA describes complex and unpredictable conditions often encountered in military operations.^16,17 Prompted by the COVID-19 pandemic, the acronym VUCA gained recognition in health care, as leaders acknowledged the challenge of navigating rapidly changing environments. van Stralen, Byrum and Inozu, recognized authorities in high reliability, cited VUCA as the rationale for implementing HRO principles and practices. They argued that “HRO solves the problem of operations and performance in a volatile, uncertain, complex, ambiguous environment.” ¹⁸ To fully appreciate the VUCA environment and its relevance to health care, it is essential to unpack the 4 components of the acronym: volatile, uncertain, complex, and ambiguous.

Volatile refers to the speed and unpredictability of change. Health care systems are interactively complex and tightly coupled, meaning that changes in 1 part of the system can rapidly impact others.^6,18,19 This high degree of interdependence amplifies volatility, especially when unexpected events occur. The rapid spread of COVID- 19 and the evolving nature of its transmission challenged health care systems’ ability to respond swiftly and effectively. Volatility also may emerge in acute medical situations, such as the rapid deterioration of a patient’s condition.

Uncertain captures the lack of predictability inherent in complex systems. In health care, uncertainty arises when there is insufficient information or when an excess of data make it difficult to discern meaningful patterns. COVID-19 and recent natural disasters have introduced profound uncertainty, as the disease’s behavior, transmission, and impact were initially unknown. Health care practitioners struggled to make decisions in real time, lacking clear guidance or precedent.^3,20 While health care planning and established protocols are grounded in predictability, the COVID-19 pandemic revealed that as complexity increases, predictability diminishes. Moreover, complexity can complicate protocol selection, as situations may arise in which multiple protocols conflict or compete. The cognitive challenge of operating in this environment is analogous to what military strategists call the fog of war, where situational awareness is low and decision-makers must navigate without clarity.²¹ Tiered huddles, a core practice in HROs, mitigate uncertainty by fostering real-time communication and shared situational awareness among teams.²⁰

Complex refers to the intricate interplay of multiple, interconnected factors within a system.²² In health care, this complexity is heightened by the sociotechnical nature of the field—where human, technology, and organizational elements all converge.¹⁹ Systems designed to prevent failures, such as redundancies and safety protocols, can themselves contribute to increased complexity. HRO practices such as tiered huddles are implemented to mitigate the risk of catastrophic failure by fostering collaborative sensemaking, enhanced situational awareness, and rapid problem-solving.^5,20,23

Ambiguous refers to situations in which multiple interpretations, causes, or outcomes are possible. It explains how, despite following protocols, failure can still occur, or how individuals may reach different conclusions from the same data. Ambiguity does not offer binary solutions; instead, it presents a murky, multifaceted reality that requires thoughtful interpretation and adaptive responses. In these moments, leaders must act decisively, even in the absence of complete information, making trade-offs that balance immediate needs with long-term consequences.

MANAGING VUCA ENVIRONMENTS WITH TIERED HUDDLES

The tiered huddle process provides several key benefits that enable real-time issue resolution. These include the rapid dissemination of vital information, enhanced agility and resilience, and improved sensemaking within a VUCA environment. Additionally, tiered huddles prevent organizational drift by fostering heightened situational awareness. The tiered huddle process also supports leadership development, as unit-level leaders gain valuable insights into strategic decision-making through active participation. Each component is outlined in the following section.

Spread: The Challenge of Communicating

“The hallmark of a great organization is how quickly bad news travels upward,” argued Jay Forrester, the father of system dynamics.²⁴ Unfortunately, steep power gradients and siloed organizational structures inhibit the flow of unfavorable information from frontline staff to senior leadership. This suppression is not necessarily intentional but is often a byproduct of organizational culture. Tiered huddles address the weakness of top-down communication models by promoting a reciprocal, bidirectional information exchange, with an emphasis on closed-loop communication. Open communication can foster a culture of trust and transparency, allowing leaders to make more informed decisions and respond quickly to emerging risks.

Enhancing Agility and Resilience

Tiered huddles contribute to a mindful infrastructure, an important aspect of maintaining organizational awareness and agility.^21,25 A mindful infrastructure enables an organization to detect early warning signs of potential disruptions and respond to them before they escalate. In this sense, tiered huddles serve as a signal-sensing mechanism, providing the agility needed to adapt to changing circumstances and prevent patient harm. Tiered huddles facilitate self-organization, a concept from chaos theory known as autopoiesis. ²⁶ This self-organizing capability allows teams to develop novel solutions in response to unforeseen challenges, exemplifying the adaptability and resilience needed in a VUCA environment. The diverse backgrounds of tiered huddle participants—both cognitively and culturally—enable a broader range of perspectives, which is critical for making sound decisions in complex and uncertain situations. “HROs cultivate diversity not just because it helps them notice more in complex environments, but also because it helps them adapt to the complexities they do spot,” argues Weick et al.²⁷ This diversity of thought and experience enhances the organization’s ability to respond to complexity, much like firefighters continually adapt to the VUCA conditions they face.

Sensemaking and Sensitivity to Operations

Leaders at all levels must be attuned to what is happening both within and outside their organization. This continual sensing of the environment—looking for weak signals, threats, and opportunities—is important for HROs. This signal detection capability allows organizations to address problems in their nascent emerging state within a tractable horizon to successfully manage fluctuations. The horizon of tractability reflects a zone where weak signals and evolving issues can be identified, addressed, and resolved early before they evolve and cascade outside of safe operations. ⁷ Tiered huddles facilitate this process by creating a platform for team members to engage in respectful, collaborative dialogue. The diversity inherent in tiered huddles also supports sensemaking, a process of interpreting and understanding complex situations.²⁷ In a VUCA environment, this multiperspective approach helps filter out noise and identify the most important signals. Tiered huddles can help overcome the phenomenon of dysfunctional momentum associated with cognitive lockup, fixation error, and tunnel vision, in which individuals or teams fixate on a particular solution, thus missing important alternative views.^21,28 By fostering a common operating picture of the fluctuating environment, tiered huddles can enable more accurate decision-making and improve organizational resilience.

Avoiding Organizational Drift

One of the most significant contributions of tiered huddles is the ability to detect early signs of organizational drift, or subtle deviations from standard practices that can accumulate over time and lead to serious failures. By continuously monitoring for precursor conditions and weak signals, tiered huddles allow organizations to intervene early and prevent drift from becoming catastrophic.^29,30 This vigilance is essential in health care, where complacency can lead to patient harm. Tiered huddles foster a culture of mindfulness and accountability, ensuring that staff stay engaged and alert to potential risks. This proactive approach is a safeguard against human error and the gradual erosion of safety standards.