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Life After Liver Transplantation
Liver transplantation (LT) is “one of the most resource-intense procedures despite significant improvements in procedures and protocols,” say researchers from Seoul National University Hospital in South Korea. But little is known about the “practical aspects of life after liver transplantation,” such as unplanned visits to the emergency department (ED) or readmission for complications. So the researchers conducted a study to find out what health care resources are used after discharge.
Of 430 patients, half visited the ED at least once, and 57% were readmitted at least once. The rate of ED visits rose from 15% at 30 days after discharge to 44% at 1 year. Readmission rates more than tripled, from 16% at 30 days to 49% at 1 year.
Contrary to other research, living donor liver transplantation was not a risk factor of readmission. Emergency LT was a risk factor for ED visits and readmission within 30 days of discharge. And although LT using the left liver lobe and pre-existing hepatitis C are known risk factors for long-term graft failure, at the researchers’ hospital hepatitis B is the most common indication for living donor LT. Most of their patients undergo LT using the right liver lobe.
Some of the identified risk factors were unexpected, the researchers say. One was donor age of < 60 years. Warm ischemic time of 15 minutes or longer was another. The researchers note that prolonged warm ischemic time increases hepatic ischemia and reperfusion injury and is related to postoperative complications, which can be a cause of frequent readmission.
Length of stay (LOS) > 2 weeks also was a risk factor for readmission. In their institution, the average LOS for patients with a warm ischemic time of < 15 minutes was 15.6 days, shorter than the overall average LOS. Shorter LOS, the researchers add, may reflect fewer immediate postoperative complications.
Although they identified no specific complication as a risk factor for readmission, the researchers found specific conditions that accounted for a relatively high proportion of readmissions and repeated readmission, including abnormal liver function test (32% of readmissions) and fever (17% of readmissions and 39% of repeated readmissions). The researchers suggest those are conditions to monitor and manage.
Notably, patients who did not require readmission or ED visits in the first 20 months almost never required unplanned health care resources thereafter.
Liver transplantation (LT) is “one of the most resource-intense procedures despite significant improvements in procedures and protocols,” say researchers from Seoul National University Hospital in South Korea. But little is known about the “practical aspects of life after liver transplantation,” such as unplanned visits to the emergency department (ED) or readmission for complications. So the researchers conducted a study to find out what health care resources are used after discharge.
Of 430 patients, half visited the ED at least once, and 57% were readmitted at least once. The rate of ED visits rose from 15% at 30 days after discharge to 44% at 1 year. Readmission rates more than tripled, from 16% at 30 days to 49% at 1 year.
Contrary to other research, living donor liver transplantation was not a risk factor of readmission. Emergency LT was a risk factor for ED visits and readmission within 30 days of discharge. And although LT using the left liver lobe and pre-existing hepatitis C are known risk factors for long-term graft failure, at the researchers’ hospital hepatitis B is the most common indication for living donor LT. Most of their patients undergo LT using the right liver lobe.
Some of the identified risk factors were unexpected, the researchers say. One was donor age of < 60 years. Warm ischemic time of 15 minutes or longer was another. The researchers note that prolonged warm ischemic time increases hepatic ischemia and reperfusion injury and is related to postoperative complications, which can be a cause of frequent readmission.
Length of stay (LOS) > 2 weeks also was a risk factor for readmission. In their institution, the average LOS for patients with a warm ischemic time of < 15 minutes was 15.6 days, shorter than the overall average LOS. Shorter LOS, the researchers add, may reflect fewer immediate postoperative complications.
Although they identified no specific complication as a risk factor for readmission, the researchers found specific conditions that accounted for a relatively high proportion of readmissions and repeated readmission, including abnormal liver function test (32% of readmissions) and fever (17% of readmissions and 39% of repeated readmissions). The researchers suggest those are conditions to monitor and manage.
Notably, patients who did not require readmission or ED visits in the first 20 months almost never required unplanned health care resources thereafter.
Liver transplantation (LT) is “one of the most resource-intense procedures despite significant improvements in procedures and protocols,” say researchers from Seoul National University Hospital in South Korea. But little is known about the “practical aspects of life after liver transplantation,” such as unplanned visits to the emergency department (ED) or readmission for complications. So the researchers conducted a study to find out what health care resources are used after discharge.
Of 430 patients, half visited the ED at least once, and 57% were readmitted at least once. The rate of ED visits rose from 15% at 30 days after discharge to 44% at 1 year. Readmission rates more than tripled, from 16% at 30 days to 49% at 1 year.
Contrary to other research, living donor liver transplantation was not a risk factor of readmission. Emergency LT was a risk factor for ED visits and readmission within 30 days of discharge. And although LT using the left liver lobe and pre-existing hepatitis C are known risk factors for long-term graft failure, at the researchers’ hospital hepatitis B is the most common indication for living donor LT. Most of their patients undergo LT using the right liver lobe.
Some of the identified risk factors were unexpected, the researchers say. One was donor age of < 60 years. Warm ischemic time of 15 minutes or longer was another. The researchers note that prolonged warm ischemic time increases hepatic ischemia and reperfusion injury and is related to postoperative complications, which can be a cause of frequent readmission.
Length of stay (LOS) > 2 weeks also was a risk factor for readmission. In their institution, the average LOS for patients with a warm ischemic time of < 15 minutes was 15.6 days, shorter than the overall average LOS. Shorter LOS, the researchers add, may reflect fewer immediate postoperative complications.
Although they identified no specific complication as a risk factor for readmission, the researchers found specific conditions that accounted for a relatively high proportion of readmissions and repeated readmission, including abnormal liver function test (32% of readmissions) and fever (17% of readmissions and 39% of repeated readmissions). The researchers suggest those are conditions to monitor and manage.
Notably, patients who did not require readmission or ED visits in the first 20 months almost never required unplanned health care resources thereafter.
Development of a Program to Support VA Community Living Centers’ Quality Improvement
US Department of Veterans Affairs (VA) Community Living Centers (CLCs) provide a dynamic array of long- and short-term health and rehabilitative services in a person-centered environment designed to meet the individual needs of veteran residents. The VA Office of Geriatrics and Extended Care (GEC) manages CLCs as part of its commitment to “optimizing the health and well-being of veterans with multiple chronic conditions, life-limiting illness, frailty or disability associated with chronic disease, aging or injury.”1
CLCs are home to veterans who require short stays before going home, as well as those who require longer or permanent domicile. CLCs also are home to several special populations of veterans, including those with spinal cord injury and those who choose palliative or hospice care. CLCs have embraced cultural transformation, creating therapeutic environments that function as real homes, with the kitchen at the center, and daily activities scheduled around the veterans’ preferences. Data about CLC quality are now available to the public, highlighting the important role of support for and continual refinement to quality improvement (QI) processes in the CLC system. 2,3
CONCERT Program
High-functioning teams are critical to achieving improvement in such processes.4 In fiscal year (FY) 2017, GEC launched a national center to engage and support CLC staff in creating high-functioning, relationship-based teams through specific QI practices, thereby aiming to improve veteran experience and quality of care. The center, known as the CLCs’ Ongoing National Center for Enhancing Resources and Training (CONCERT), is based on extensive VA-funded research in CLCs5-7 and builds on existing, evidence-based literature emphasizing the importance of strengths-based learning, collaborative problem solving, and structured observation.8-13 The CONCERT mission is to support CLCs in ongoing QI efforts, providing guidance, training, and resources. This article summarizes the previous research on which CONCERT is based and describes its current activities, which focus on implementing a national team-based quality improvement initiative.
Earlier VA-funded CLC research included a VA Office of Patient Centered Care and Cultural Transformation local innovation project and 2 VA Office of Research and Development-funded research studies. The local innovation project focused on strengthening staff leadership and relational skills in 1 CLC by engaging leaders and staff in collaborative work to reduce stress. The goal was to build high-functioning team skills through shared projects that created positive work experiences and reduced job-related stress while also improving veteran experience and quality of care.14,15 Over the course of a year, 2 national consultants in nursing home quality improvement worked with CLC leadership and staff, including conducting nine 4-day site visits. Using an approach designed to foster development of high-functioning teams, individual CLC neighborhoods (ie, units) developed and implemented neighborhood-initiated, neighborhood-based pilot projects, such as an individualized finger foods dining option for residents with dementia who became distressed when sitting at a table during a meal. Outcomes of these projects included improved staff communication and staff satisfaction, particularly psychological safety.
In the concurrently conducted pilot research study, a research team comprehensively assessed the person-centered care efforts of 3 CLCs prior to their construction of Green House-type (small house) homes. This mixed-methods study included more than 50 qualitative interviews conducted with VA medical center leadership and CLC staff and residents. Researchers also administered online employee surveys and conducted site visits, including more than 60 hours of direct observation of CLC life and team functioning. The local institutional review boards approved all study procedures, and researchers notified local unions.
Analyses highlighted 2 important aspects of person-centered care not captured by then-existing measurement instruments: the type, quality, and number of staff/resident interactions and the type, quality, and level of resident engagement. The team therefore developed a structured, systematic, observation-based instrument to measure these concepts.5 But while researchers found this instrument useful, it was too complex to be used by CLC staff for QI.
LOCK Quality Improvement
A later and larger research study addressed this issue. In the study, researchers worked with CLC staff to convert the complex observation-based research instrument into several structured tools that were easier for CLC staff to use.6 The researchers then incorporated their experience with the prior local innovation project and designed and implemented a QI program, which operationalized an evidence-based bundle of practices to implement the new tools in 6 CLCs. Researchers called the bundle of practices “LOCK”: (1) Learn from the bright spots; (2) Observe; (3) Collaborate in huddles; and (4) Keep it bite-sized.
Learn from the bright spots. Studies on strengths-based learning indicate that recognizing and sharing positive instances of ideal practice helps provide clear direction regarding what needs to be done differently to achieve success. Identifying and learning from outlying instances of successful practice encourages staff to continue those behaviors and gives staff tangible examples of how they may improve.16-19 That is, concentrating on instances where a negative outcome was at risk of occurring but did not occur (ie, a positive outlier or “bright spot”) enables staff to analyze what facilitated the success and design and pilot strategies to replicate it.
Observe. Human factors engineering is built on the principle that integrated approaches for studying work systems can identify areas for improvement.8 Observation is a key tool in this approach. A recent review of 69 studies that used observation to assess clinical performance found it useful in identifying factors affecting quality and safety.9
Collaborate in huddles. A necessary component to overcoming barriers to successful QI is having high-functioning teams effectively coordinate work. In the theory of relational coordination, this is operationalized as high-quality interactions (frequent, timely, and accurate communication) and high-quality relationships (share knowledge, shared goals, and mutual respect).10,11 Improved relational coordination can lead to higher quality of care outcomes and job satisfaction by enabling individuals to manage their tasks with less delay, more rapid and effective responses, fewer errors, and less wasted effort.12
Keep it bite-sized. Regular practice of a new behavior is one of the keys to making that new behavior part of an automatic routine (ie, a habit). To be successfully integrated into staff work routines, QI initiatives must be perceived as congruent with and easily integrated into care goals and workplace practices. Quick, focused, team-building and solution-oriented QI initiatives, therefore, have the greatest chance of success, particularly if staff feel they have little time for participating in new initiatives.13
Researchers designed the 4 LOCK practices to be interrelated and build on one another, creating a bundle to be used together to help facilitate positive change in resident/staff interactions and resident engagement.7 For 6 months, researchers studied the 6 CLCs’ use of the new structured observation tools as part of the LOCK-based QI program. The participating CLCs had such success in improving staff interactions with residents and residents’ engagement in CLC life that GEC, under the CONCERT umbrella, rolled out the LOCK bundle of practices to CLCs nationwide.20
CONCERT’s current activities focus on helping CLCs implement the LOCK bundle nationwide as a relational coordination-based national QI initiative designed to improve quality of care and staff satisfaction. The CONCERT team began this implementation in FY 2017 using a train-the-trainer approach through a staggered veterans integrated service network (VISN) rollout. Each CLC sent 2 leaders to a VISN-wide training program at a host CLC site (the host site was able to have more participants attend). Afterward, the CONCERT team provided individualized phone support to help CLCs implement the program. A VA Pulse (intranet-based social media portal) site hosts all training materials, program videos, an active blog, community discussions, etc.
In FY 2018, the program shifted to a VISN-based support system, with a CONCERT team member assigned to each VISN and VISN-based webinars to facilitate information exchange, collaboration, and group learning. In FY 2018, the CONCERT team also conducted site visits to selected CLCs with strong implementation success records to learn about program facilitators and to disseminate the lessons learned. Spanning FYs 2018 and 2019, the CONCERT team also supports historically low-performing CLCs through a series of rapid-cycle learning intensives based on the Institute for Healthcare Improvement breakthrough collaborative series model for accelerated and sustained QI.21 These incorporate in-person or virtual learning sessions, in which participants learn about and share effective practices, and between-session learning assignments, to facilitate the piloting, implementation, and sustainment of system changes. As part of the CONCERT continuous QI process, the CONCERT team closely monitors the impact of the program and continues to pilot, adapt, and change practices as it learns more about how best to help CLCs improve.
Conclusion
A key CONCERT principle is that health care systems create health care outcomes. The CONCERT team uses the theory of relational coordination to support implementation of the LOCK bundle of practices to help CLCs change their systems to achieve high performance. Through implementation of the LOCK bundle of practices, CLC staff develop, pilot, and spread new systems for communication, teamwork, and collaborative problem solving, as well as developing skills to participate effectively in these systems. CONCERT represents just 1 way VA supports CLCs in their continual journeys toward ever-improved quality of veteran care.
Acknowledgments
The authors thank Barbara Frank and Cathie Brady for their contributions to the development of the CONCERT program.
1. US Department of Veterans Affairs, Geriatrics and Extended Care Services (GEC). https://www.va.gov/GERIATRICS/index.asp. Updated February 25, 2019. Accessed April 9, 2019.
2. US Department of Veterans Affairs. https://www.accesstocare.va.gov/CNH/Statemap. Accessed April 10, 2019.
3. US Department of Veterans Affairs. https://www.va.gov/QUALITYOFCARE/apps/aspire/clcsurvey.aspx/. U
4. Gittell JH, Weinberg D, Pfefferle S, Bishop C. Impact of relational coordination on job satisfaction and quality outcomes: a study of nursing homes. Hum Resour Manag. 2008;18(2):154-170
5. Snow AL, Dodson, ML, Palmer JA, et al. Development of a new systematic observation tool of nursing home resident and staff engagement and relationship. Gerontologist. 2018;58(2):e15-e24.
6. Hartmann CW, Palmer JA, Mills WL, et al. Adaptation of a nursing home culture change research instrument for frontline staff quality improvement use. Psychol Serv. 2017;14(3):337-346.
7. Mills WL, Pimentel CB, Palmer JA, et al. Applying a theory-driven framework to guide quality improvement efforts in nursing homes: the LOCK model. Gerontologist. 2018;58(3):598-605.
8. Caravon P, Hundt AS, Karsh B, et al. Work system design for patient safety: the SEIPS model. Quality & Safety in Health Care. 2006;15(suppl 1), i50-i58.
9. Yanes AF, McElroy LM, Abecassis ZA, Holl J, Woods D, Ladner DP. Observation for assessment of clinician performance: a narrative review. BMJ Qual Saf. 2016;25(1):46-55.
10. Gittell JH. Supervisory span, relational coordination and flight departure performance: a reassessment of postbureaucracy theory. Organ Sci. 2011;12(4):468-483.
11. Gittell JH. New Directions for Relational Coordination Theory. In Spreitzer GM, Cameron KS, eds. The Oxford Handbook of Positive Organizational Scholarship. Oxford University Press: New York; 2012:400-411.
12. Weinberg DB, Lusenhop RW, Gittell JH, Kautz CM. Coordination between formal providers and informal caregivers. Health Care Manage Rev. 2007;32(2):140-149.
13. Phillips J, Hebish LJ, Mann S, Ching JM, Blackmore CC. Engaging frontline leaders and staff in real-time improvement. Jt Comm J Qual Patient Saf. 2016;42(4):170-183.
14. Farrell D, Brady C, Frank B. Meeting the Leadership Challenge in Long-Term Care: What You Do Matters. Health Professions Press: Baltimore, MD; 2011.
15. Brady C, Farrell D, Frank B. A Long-Term Leaders’ Guide to High Performance: Doing Better Together. Health Professions Press: Baltimore, MD; 2018.
16. Bradley EH, Curry LA, Ramanadhan S, Rowe L, Nembhard IM, Krumholz HM. Research in action: using positive deviance to improve quality of health care. Implement Sci. 2009;4:25.
17. Marsh DR, Schroeder DG, Dearden KA, Sternin J, Sternin M. The power of positive deviance. BMJ. 2004; 329(7475):1177-1179.
18. Vogt K, Johnson F, Fraser V, et al. An innovative, strengths-based, peer mentoring approach to professional development for registered dietitians. Can J Diet Pract Res. 2015;76(4):185-189.
19. Beckett P, Field J, Molloy L, Yu N, Holmes D, Pile E. Practice what you preach: developing person-centered culture in inpatient mental health settings through strengths-based, transformational leadership. Issues Ment Health Nurs. 2013;34(8):595-601.
20. Hartmann CW, Mills WL, Pimentel CB, et al. Impact of intervention to improve nursing home resident-staff interactions and engagement. Gerontologist. 2018;58(4):e291-e301.
21. Institute for Healthcare Improvement. The breakthrough series: IHI’s collaborative model for achieving breakthrough improvement. http://www.ihi.org/resources/Pages/IHIWhitePapers/TheBreakthroughSeriesIHIsCollaborativeModelforAchievingBreakthroughImprovement.aspx. Published 2003. Accessed April 9, 2019.
US Department of Veterans Affairs (VA) Community Living Centers (CLCs) provide a dynamic array of long- and short-term health and rehabilitative services in a person-centered environment designed to meet the individual needs of veteran residents. The VA Office of Geriatrics and Extended Care (GEC) manages CLCs as part of its commitment to “optimizing the health and well-being of veterans with multiple chronic conditions, life-limiting illness, frailty or disability associated with chronic disease, aging or injury.”1
CLCs are home to veterans who require short stays before going home, as well as those who require longer or permanent domicile. CLCs also are home to several special populations of veterans, including those with spinal cord injury and those who choose palliative or hospice care. CLCs have embraced cultural transformation, creating therapeutic environments that function as real homes, with the kitchen at the center, and daily activities scheduled around the veterans’ preferences. Data about CLC quality are now available to the public, highlighting the important role of support for and continual refinement to quality improvement (QI) processes in the CLC system. 2,3
CONCERT Program
High-functioning teams are critical to achieving improvement in such processes.4 In fiscal year (FY) 2017, GEC launched a national center to engage and support CLC staff in creating high-functioning, relationship-based teams through specific QI practices, thereby aiming to improve veteran experience and quality of care. The center, known as the CLCs’ Ongoing National Center for Enhancing Resources and Training (CONCERT), is based on extensive VA-funded research in CLCs5-7 and builds on existing, evidence-based literature emphasizing the importance of strengths-based learning, collaborative problem solving, and structured observation.8-13 The CONCERT mission is to support CLCs in ongoing QI efforts, providing guidance, training, and resources. This article summarizes the previous research on which CONCERT is based and describes its current activities, which focus on implementing a national team-based quality improvement initiative.
Earlier VA-funded CLC research included a VA Office of Patient Centered Care and Cultural Transformation local innovation project and 2 VA Office of Research and Development-funded research studies. The local innovation project focused on strengthening staff leadership and relational skills in 1 CLC by engaging leaders and staff in collaborative work to reduce stress. The goal was to build high-functioning team skills through shared projects that created positive work experiences and reduced job-related stress while also improving veteran experience and quality of care.14,15 Over the course of a year, 2 national consultants in nursing home quality improvement worked with CLC leadership and staff, including conducting nine 4-day site visits. Using an approach designed to foster development of high-functioning teams, individual CLC neighborhoods (ie, units) developed and implemented neighborhood-initiated, neighborhood-based pilot projects, such as an individualized finger foods dining option for residents with dementia who became distressed when sitting at a table during a meal. Outcomes of these projects included improved staff communication and staff satisfaction, particularly psychological safety.
In the concurrently conducted pilot research study, a research team comprehensively assessed the person-centered care efforts of 3 CLCs prior to their construction of Green House-type (small house) homes. This mixed-methods study included more than 50 qualitative interviews conducted with VA medical center leadership and CLC staff and residents. Researchers also administered online employee surveys and conducted site visits, including more than 60 hours of direct observation of CLC life and team functioning. The local institutional review boards approved all study procedures, and researchers notified local unions.
Analyses highlighted 2 important aspects of person-centered care not captured by then-existing measurement instruments: the type, quality, and number of staff/resident interactions and the type, quality, and level of resident engagement. The team therefore developed a structured, systematic, observation-based instrument to measure these concepts.5 But while researchers found this instrument useful, it was too complex to be used by CLC staff for QI.
LOCK Quality Improvement
A later and larger research study addressed this issue. In the study, researchers worked with CLC staff to convert the complex observation-based research instrument into several structured tools that were easier for CLC staff to use.6 The researchers then incorporated their experience with the prior local innovation project and designed and implemented a QI program, which operationalized an evidence-based bundle of practices to implement the new tools in 6 CLCs. Researchers called the bundle of practices “LOCK”: (1) Learn from the bright spots; (2) Observe; (3) Collaborate in huddles; and (4) Keep it bite-sized.
Learn from the bright spots. Studies on strengths-based learning indicate that recognizing and sharing positive instances of ideal practice helps provide clear direction regarding what needs to be done differently to achieve success. Identifying and learning from outlying instances of successful practice encourages staff to continue those behaviors and gives staff tangible examples of how they may improve.16-19 That is, concentrating on instances where a negative outcome was at risk of occurring but did not occur (ie, a positive outlier or “bright spot”) enables staff to analyze what facilitated the success and design and pilot strategies to replicate it.
Observe. Human factors engineering is built on the principle that integrated approaches for studying work systems can identify areas for improvement.8 Observation is a key tool in this approach. A recent review of 69 studies that used observation to assess clinical performance found it useful in identifying factors affecting quality and safety.9
Collaborate in huddles. A necessary component to overcoming barriers to successful QI is having high-functioning teams effectively coordinate work. In the theory of relational coordination, this is operationalized as high-quality interactions (frequent, timely, and accurate communication) and high-quality relationships (share knowledge, shared goals, and mutual respect).10,11 Improved relational coordination can lead to higher quality of care outcomes and job satisfaction by enabling individuals to manage their tasks with less delay, more rapid and effective responses, fewer errors, and less wasted effort.12
Keep it bite-sized. Regular practice of a new behavior is one of the keys to making that new behavior part of an automatic routine (ie, a habit). To be successfully integrated into staff work routines, QI initiatives must be perceived as congruent with and easily integrated into care goals and workplace practices. Quick, focused, team-building and solution-oriented QI initiatives, therefore, have the greatest chance of success, particularly if staff feel they have little time for participating in new initiatives.13
Researchers designed the 4 LOCK practices to be interrelated and build on one another, creating a bundle to be used together to help facilitate positive change in resident/staff interactions and resident engagement.7 For 6 months, researchers studied the 6 CLCs’ use of the new structured observation tools as part of the LOCK-based QI program. The participating CLCs had such success in improving staff interactions with residents and residents’ engagement in CLC life that GEC, under the CONCERT umbrella, rolled out the LOCK bundle of practices to CLCs nationwide.20
CONCERT’s current activities focus on helping CLCs implement the LOCK bundle nationwide as a relational coordination-based national QI initiative designed to improve quality of care and staff satisfaction. The CONCERT team began this implementation in FY 2017 using a train-the-trainer approach through a staggered veterans integrated service network (VISN) rollout. Each CLC sent 2 leaders to a VISN-wide training program at a host CLC site (the host site was able to have more participants attend). Afterward, the CONCERT team provided individualized phone support to help CLCs implement the program. A VA Pulse (intranet-based social media portal) site hosts all training materials, program videos, an active blog, community discussions, etc.
In FY 2018, the program shifted to a VISN-based support system, with a CONCERT team member assigned to each VISN and VISN-based webinars to facilitate information exchange, collaboration, and group learning. In FY 2018, the CONCERT team also conducted site visits to selected CLCs with strong implementation success records to learn about program facilitators and to disseminate the lessons learned. Spanning FYs 2018 and 2019, the CONCERT team also supports historically low-performing CLCs through a series of rapid-cycle learning intensives based on the Institute for Healthcare Improvement breakthrough collaborative series model for accelerated and sustained QI.21 These incorporate in-person or virtual learning sessions, in which participants learn about and share effective practices, and between-session learning assignments, to facilitate the piloting, implementation, and sustainment of system changes. As part of the CONCERT continuous QI process, the CONCERT team closely monitors the impact of the program and continues to pilot, adapt, and change practices as it learns more about how best to help CLCs improve.
Conclusion
A key CONCERT principle is that health care systems create health care outcomes. The CONCERT team uses the theory of relational coordination to support implementation of the LOCK bundle of practices to help CLCs change their systems to achieve high performance. Through implementation of the LOCK bundle of practices, CLC staff develop, pilot, and spread new systems for communication, teamwork, and collaborative problem solving, as well as developing skills to participate effectively in these systems. CONCERT represents just 1 way VA supports CLCs in their continual journeys toward ever-improved quality of veteran care.
Acknowledgments
The authors thank Barbara Frank and Cathie Brady for their contributions to the development of the CONCERT program.
US Department of Veterans Affairs (VA) Community Living Centers (CLCs) provide a dynamic array of long- and short-term health and rehabilitative services in a person-centered environment designed to meet the individual needs of veteran residents. The VA Office of Geriatrics and Extended Care (GEC) manages CLCs as part of its commitment to “optimizing the health and well-being of veterans with multiple chronic conditions, life-limiting illness, frailty or disability associated with chronic disease, aging or injury.”1
CLCs are home to veterans who require short stays before going home, as well as those who require longer or permanent domicile. CLCs also are home to several special populations of veterans, including those with spinal cord injury and those who choose palliative or hospice care. CLCs have embraced cultural transformation, creating therapeutic environments that function as real homes, with the kitchen at the center, and daily activities scheduled around the veterans’ preferences. Data about CLC quality are now available to the public, highlighting the important role of support for and continual refinement to quality improvement (QI) processes in the CLC system. 2,3
CONCERT Program
High-functioning teams are critical to achieving improvement in such processes.4 In fiscal year (FY) 2017, GEC launched a national center to engage and support CLC staff in creating high-functioning, relationship-based teams through specific QI practices, thereby aiming to improve veteran experience and quality of care. The center, known as the CLCs’ Ongoing National Center for Enhancing Resources and Training (CONCERT), is based on extensive VA-funded research in CLCs5-7 and builds on existing, evidence-based literature emphasizing the importance of strengths-based learning, collaborative problem solving, and structured observation.8-13 The CONCERT mission is to support CLCs in ongoing QI efforts, providing guidance, training, and resources. This article summarizes the previous research on which CONCERT is based and describes its current activities, which focus on implementing a national team-based quality improvement initiative.
Earlier VA-funded CLC research included a VA Office of Patient Centered Care and Cultural Transformation local innovation project and 2 VA Office of Research and Development-funded research studies. The local innovation project focused on strengthening staff leadership and relational skills in 1 CLC by engaging leaders and staff in collaborative work to reduce stress. The goal was to build high-functioning team skills through shared projects that created positive work experiences and reduced job-related stress while also improving veteran experience and quality of care.14,15 Over the course of a year, 2 national consultants in nursing home quality improvement worked with CLC leadership and staff, including conducting nine 4-day site visits. Using an approach designed to foster development of high-functioning teams, individual CLC neighborhoods (ie, units) developed and implemented neighborhood-initiated, neighborhood-based pilot projects, such as an individualized finger foods dining option for residents with dementia who became distressed when sitting at a table during a meal. Outcomes of these projects included improved staff communication and staff satisfaction, particularly psychological safety.
In the concurrently conducted pilot research study, a research team comprehensively assessed the person-centered care efforts of 3 CLCs prior to their construction of Green House-type (small house) homes. This mixed-methods study included more than 50 qualitative interviews conducted with VA medical center leadership and CLC staff and residents. Researchers also administered online employee surveys and conducted site visits, including more than 60 hours of direct observation of CLC life and team functioning. The local institutional review boards approved all study procedures, and researchers notified local unions.
Analyses highlighted 2 important aspects of person-centered care not captured by then-existing measurement instruments: the type, quality, and number of staff/resident interactions and the type, quality, and level of resident engagement. The team therefore developed a structured, systematic, observation-based instrument to measure these concepts.5 But while researchers found this instrument useful, it was too complex to be used by CLC staff for QI.
LOCK Quality Improvement
A later and larger research study addressed this issue. In the study, researchers worked with CLC staff to convert the complex observation-based research instrument into several structured tools that were easier for CLC staff to use.6 The researchers then incorporated their experience with the prior local innovation project and designed and implemented a QI program, which operationalized an evidence-based bundle of practices to implement the new tools in 6 CLCs. Researchers called the bundle of practices “LOCK”: (1) Learn from the bright spots; (2) Observe; (3) Collaborate in huddles; and (4) Keep it bite-sized.
Learn from the bright spots. Studies on strengths-based learning indicate that recognizing and sharing positive instances of ideal practice helps provide clear direction regarding what needs to be done differently to achieve success. Identifying and learning from outlying instances of successful practice encourages staff to continue those behaviors and gives staff tangible examples of how they may improve.16-19 That is, concentrating on instances where a negative outcome was at risk of occurring but did not occur (ie, a positive outlier or “bright spot”) enables staff to analyze what facilitated the success and design and pilot strategies to replicate it.
Observe. Human factors engineering is built on the principle that integrated approaches for studying work systems can identify areas for improvement.8 Observation is a key tool in this approach. A recent review of 69 studies that used observation to assess clinical performance found it useful in identifying factors affecting quality and safety.9
Collaborate in huddles. A necessary component to overcoming barriers to successful QI is having high-functioning teams effectively coordinate work. In the theory of relational coordination, this is operationalized as high-quality interactions (frequent, timely, and accurate communication) and high-quality relationships (share knowledge, shared goals, and mutual respect).10,11 Improved relational coordination can lead to higher quality of care outcomes and job satisfaction by enabling individuals to manage their tasks with less delay, more rapid and effective responses, fewer errors, and less wasted effort.12
Keep it bite-sized. Regular practice of a new behavior is one of the keys to making that new behavior part of an automatic routine (ie, a habit). To be successfully integrated into staff work routines, QI initiatives must be perceived as congruent with and easily integrated into care goals and workplace practices. Quick, focused, team-building and solution-oriented QI initiatives, therefore, have the greatest chance of success, particularly if staff feel they have little time for participating in new initiatives.13
Researchers designed the 4 LOCK practices to be interrelated and build on one another, creating a bundle to be used together to help facilitate positive change in resident/staff interactions and resident engagement.7 For 6 months, researchers studied the 6 CLCs’ use of the new structured observation tools as part of the LOCK-based QI program. The participating CLCs had such success in improving staff interactions with residents and residents’ engagement in CLC life that GEC, under the CONCERT umbrella, rolled out the LOCK bundle of practices to CLCs nationwide.20
CONCERT’s current activities focus on helping CLCs implement the LOCK bundle nationwide as a relational coordination-based national QI initiative designed to improve quality of care and staff satisfaction. The CONCERT team began this implementation in FY 2017 using a train-the-trainer approach through a staggered veterans integrated service network (VISN) rollout. Each CLC sent 2 leaders to a VISN-wide training program at a host CLC site (the host site was able to have more participants attend). Afterward, the CONCERT team provided individualized phone support to help CLCs implement the program. A VA Pulse (intranet-based social media portal) site hosts all training materials, program videos, an active blog, community discussions, etc.
In FY 2018, the program shifted to a VISN-based support system, with a CONCERT team member assigned to each VISN and VISN-based webinars to facilitate information exchange, collaboration, and group learning. In FY 2018, the CONCERT team also conducted site visits to selected CLCs with strong implementation success records to learn about program facilitators and to disseminate the lessons learned. Spanning FYs 2018 and 2019, the CONCERT team also supports historically low-performing CLCs through a series of rapid-cycle learning intensives based on the Institute for Healthcare Improvement breakthrough collaborative series model for accelerated and sustained QI.21 These incorporate in-person or virtual learning sessions, in which participants learn about and share effective practices, and between-session learning assignments, to facilitate the piloting, implementation, and sustainment of system changes. As part of the CONCERT continuous QI process, the CONCERT team closely monitors the impact of the program and continues to pilot, adapt, and change practices as it learns more about how best to help CLCs improve.
Conclusion
A key CONCERT principle is that health care systems create health care outcomes. The CONCERT team uses the theory of relational coordination to support implementation of the LOCK bundle of practices to help CLCs change their systems to achieve high performance. Through implementation of the LOCK bundle of practices, CLC staff develop, pilot, and spread new systems for communication, teamwork, and collaborative problem solving, as well as developing skills to participate effectively in these systems. CONCERT represents just 1 way VA supports CLCs in their continual journeys toward ever-improved quality of veteran care.
Acknowledgments
The authors thank Barbara Frank and Cathie Brady for their contributions to the development of the CONCERT program.
1. US Department of Veterans Affairs, Geriatrics and Extended Care Services (GEC). https://www.va.gov/GERIATRICS/index.asp. Updated February 25, 2019. Accessed April 9, 2019.
2. US Department of Veterans Affairs. https://www.accesstocare.va.gov/CNH/Statemap. Accessed April 10, 2019.
3. US Department of Veterans Affairs. https://www.va.gov/QUALITYOFCARE/apps/aspire/clcsurvey.aspx/. U
4. Gittell JH, Weinberg D, Pfefferle S, Bishop C. Impact of relational coordination on job satisfaction and quality outcomes: a study of nursing homes. Hum Resour Manag. 2008;18(2):154-170
5. Snow AL, Dodson, ML, Palmer JA, et al. Development of a new systematic observation tool of nursing home resident and staff engagement and relationship. Gerontologist. 2018;58(2):e15-e24.
6. Hartmann CW, Palmer JA, Mills WL, et al. Adaptation of a nursing home culture change research instrument for frontline staff quality improvement use. Psychol Serv. 2017;14(3):337-346.
7. Mills WL, Pimentel CB, Palmer JA, et al. Applying a theory-driven framework to guide quality improvement efforts in nursing homes: the LOCK model. Gerontologist. 2018;58(3):598-605.
8. Caravon P, Hundt AS, Karsh B, et al. Work system design for patient safety: the SEIPS model. Quality & Safety in Health Care. 2006;15(suppl 1), i50-i58.
9. Yanes AF, McElroy LM, Abecassis ZA, Holl J, Woods D, Ladner DP. Observation for assessment of clinician performance: a narrative review. BMJ Qual Saf. 2016;25(1):46-55.
10. Gittell JH. Supervisory span, relational coordination and flight departure performance: a reassessment of postbureaucracy theory. Organ Sci. 2011;12(4):468-483.
11. Gittell JH. New Directions for Relational Coordination Theory. In Spreitzer GM, Cameron KS, eds. The Oxford Handbook of Positive Organizational Scholarship. Oxford University Press: New York; 2012:400-411.
12. Weinberg DB, Lusenhop RW, Gittell JH, Kautz CM. Coordination between formal providers and informal caregivers. Health Care Manage Rev. 2007;32(2):140-149.
13. Phillips J, Hebish LJ, Mann S, Ching JM, Blackmore CC. Engaging frontline leaders and staff in real-time improvement. Jt Comm J Qual Patient Saf. 2016;42(4):170-183.
14. Farrell D, Brady C, Frank B. Meeting the Leadership Challenge in Long-Term Care: What You Do Matters. Health Professions Press: Baltimore, MD; 2011.
15. Brady C, Farrell D, Frank B. A Long-Term Leaders’ Guide to High Performance: Doing Better Together. Health Professions Press: Baltimore, MD; 2018.
16. Bradley EH, Curry LA, Ramanadhan S, Rowe L, Nembhard IM, Krumholz HM. Research in action: using positive deviance to improve quality of health care. Implement Sci. 2009;4:25.
17. Marsh DR, Schroeder DG, Dearden KA, Sternin J, Sternin M. The power of positive deviance. BMJ. 2004; 329(7475):1177-1179.
18. Vogt K, Johnson F, Fraser V, et al. An innovative, strengths-based, peer mentoring approach to professional development for registered dietitians. Can J Diet Pract Res. 2015;76(4):185-189.
19. Beckett P, Field J, Molloy L, Yu N, Holmes D, Pile E. Practice what you preach: developing person-centered culture in inpatient mental health settings through strengths-based, transformational leadership. Issues Ment Health Nurs. 2013;34(8):595-601.
20. Hartmann CW, Mills WL, Pimentel CB, et al. Impact of intervention to improve nursing home resident-staff interactions and engagement. Gerontologist. 2018;58(4):e291-e301.
21. Institute for Healthcare Improvement. The breakthrough series: IHI’s collaborative model for achieving breakthrough improvement. http://www.ihi.org/resources/Pages/IHIWhitePapers/TheBreakthroughSeriesIHIsCollaborativeModelforAchievingBreakthroughImprovement.aspx. Published 2003. Accessed April 9, 2019.
1. US Department of Veterans Affairs, Geriatrics and Extended Care Services (GEC). https://www.va.gov/GERIATRICS/index.asp. Updated February 25, 2019. Accessed April 9, 2019.
2. US Department of Veterans Affairs. https://www.accesstocare.va.gov/CNH/Statemap. Accessed April 10, 2019.
3. US Department of Veterans Affairs. https://www.va.gov/QUALITYOFCARE/apps/aspire/clcsurvey.aspx/. U
4. Gittell JH, Weinberg D, Pfefferle S, Bishop C. Impact of relational coordination on job satisfaction and quality outcomes: a study of nursing homes. Hum Resour Manag. 2008;18(2):154-170
5. Snow AL, Dodson, ML, Palmer JA, et al. Development of a new systematic observation tool of nursing home resident and staff engagement and relationship. Gerontologist. 2018;58(2):e15-e24.
6. Hartmann CW, Palmer JA, Mills WL, et al. Adaptation of a nursing home culture change research instrument for frontline staff quality improvement use. Psychol Serv. 2017;14(3):337-346.
7. Mills WL, Pimentel CB, Palmer JA, et al. Applying a theory-driven framework to guide quality improvement efforts in nursing homes: the LOCK model. Gerontologist. 2018;58(3):598-605.
8. Caravon P, Hundt AS, Karsh B, et al. Work system design for patient safety: the SEIPS model. Quality & Safety in Health Care. 2006;15(suppl 1), i50-i58.
9. Yanes AF, McElroy LM, Abecassis ZA, Holl J, Woods D, Ladner DP. Observation for assessment of clinician performance: a narrative review. BMJ Qual Saf. 2016;25(1):46-55.
10. Gittell JH. Supervisory span, relational coordination and flight departure performance: a reassessment of postbureaucracy theory. Organ Sci. 2011;12(4):468-483.
11. Gittell JH. New Directions for Relational Coordination Theory. In Spreitzer GM, Cameron KS, eds. The Oxford Handbook of Positive Organizational Scholarship. Oxford University Press: New York; 2012:400-411.
12. Weinberg DB, Lusenhop RW, Gittell JH, Kautz CM. Coordination between formal providers and informal caregivers. Health Care Manage Rev. 2007;32(2):140-149.
13. Phillips J, Hebish LJ, Mann S, Ching JM, Blackmore CC. Engaging frontline leaders and staff in real-time improvement. Jt Comm J Qual Patient Saf. 2016;42(4):170-183.
14. Farrell D, Brady C, Frank B. Meeting the Leadership Challenge in Long-Term Care: What You Do Matters. Health Professions Press: Baltimore, MD; 2011.
15. Brady C, Farrell D, Frank B. A Long-Term Leaders’ Guide to High Performance: Doing Better Together. Health Professions Press: Baltimore, MD; 2018.
16. Bradley EH, Curry LA, Ramanadhan S, Rowe L, Nembhard IM, Krumholz HM. Research in action: using positive deviance to improve quality of health care. Implement Sci. 2009;4:25.
17. Marsh DR, Schroeder DG, Dearden KA, Sternin J, Sternin M. The power of positive deviance. BMJ. 2004; 329(7475):1177-1179.
18. Vogt K, Johnson F, Fraser V, et al. An innovative, strengths-based, peer mentoring approach to professional development for registered dietitians. Can J Diet Pract Res. 2015;76(4):185-189.
19. Beckett P, Field J, Molloy L, Yu N, Holmes D, Pile E. Practice what you preach: developing person-centered culture in inpatient mental health settings through strengths-based, transformational leadership. Issues Ment Health Nurs. 2013;34(8):595-601.
20. Hartmann CW, Mills WL, Pimentel CB, et al. Impact of intervention to improve nursing home resident-staff interactions and engagement. Gerontologist. 2018;58(4):e291-e301.
21. Institute for Healthcare Improvement. The breakthrough series: IHI’s collaborative model for achieving breakthrough improvement. http://www.ihi.org/resources/Pages/IHIWhitePapers/TheBreakthroughSeriesIHIsCollaborativeModelforAchievingBreakthroughImprovement.aspx. Published 2003. Accessed April 9, 2019.
Improving Health Care for Veterans With Gulf War Illness
Many veterans of the Gulf War are experiencing deployment-related chronic illness, known as Gulf War illness (GWI). Symptoms of GWI include cognitive impairments (mood and memory), chronic fatigue, musculoskeletal pain, gastrointestinal (GI) disorders, respiratory problems, and skin rashes.1-4 Three survey studies of the physical and mental health of a large cohort of Gulf War and Gulf era veterans, conducted by the US Department of Veterans Affairs (VA) Office of Public Health, established the increased prevalence of GWI in the decades that followed the end of the conflict.5-7 Thus, GWI has become the signature adverse health-related outcome of the Gulf War. Quality improvement (QI) within the Veterans Health Administration (VHA) is needed in the diagnosis and treatment of GWI.
Background
GWI was first termed chronic multisymptom illness (CMI) by the Centers for Disease Control and Prevention (CDC). According to the CDC-10 case definition, CMI in veterans of the 1990-1991 Gulf War is defined as having ≥ 1 symptoms lasting ≥ 6 months in at least 2 of 3 categories: fatigue, depressed mood and altered cognition, and musculoskeletal pain.3 The Kansas case definition of GWI is more specific and is defined as having moderate-to-severe symptoms that are unexplained by any other diagnosis, in at least 3 of 6 categories: fatigue/sleep, somatic pain, neurologic/cognition/mood, GI, respiratory, and skin.4 Although chronic unexplained symptoms have occurred after other modern conflicts, the prevalence of GWI among Gulf War veterans has proven higher than those of prior conflicts.8
The Persian Gulf War Veterans Act of 1998 and the Veterans Programs Enhancement Act of 1998 mandated studies by the Institute of Medicine (IOM) on the biologic and chemical exposures that may have contributed to illness in the Kuwaiti theater of operations.9 However, elucidating the etiology and underlying pathophysiology of GWI has been a major research challenge. In the absence of objective diagnostic measures, an understanding of the fundamental pathophysiology, evidence-based treatments, a single case definition, and definitive guidelines for health care providers (HCPs) for the diagnosis and management of GWI has not been produced. As a result, veterans with GWI have struggled for nearly 3 decades to find a consistent diagnosis of and an effective treatment for their condition.
According to a report by the Government Accountability Office (GAO), the VA approved only 17% of claims for compensation for veterans with GWI from 2011 to 2015, about one-third the level of approval for all other claimed disabilities.10 Although the VA applied GAO recommendations to improve the compensation process, many veterans consider that their illness is treated as psychosomatic in clinical practice, despite emerging evidence of GWI-associated biomarkers.11 Others think they have been forgotten due to their short 1-year period of service in the Gulf War.12 To realign research, guidelines, clinical care, and the health care experience of veterans with GWI, focused QI within VHA is urgently needed.
Veterans of Operations Enduring Freedom, Iraqi Freedom, and New Dawn (OEF/OIF/OND) are experiencing similar CMI symptoms. A study of US Army Reserve OEF/OIF veterans found that > 60% met the CDC-10 case definition for GWI 1-year postdeployment.13 Thus, CMI is emerging as a serious health problem for post-9/11 veterans. The evidence of postdeployment CMI among veterans of recent conflicts underscores the need to increase efforts at a national level, beginning with the VHA. This report includes a summary of Gulf War veterans’ experiences at the Minneapolis VA Health Care System (MVAHCS) and a proposal for QI of MVAHCS processes focused on HCP education and clinical care.
Methods
To determine areas of GWI health care that needed QI at the MVAHCS, veterans with GWI were contacted for a telephone survey. These veterans had participated in the Gulf War Illness Inflammation Reduction Trial (ClinicalTrials.gov. Identifier: NCT02506192). Therefore, all met the Kansas case definition for GWI.4 The aim of the survey was to characterize veterans’ experiences seeking health care for chronic postdeployment symptoms.
Sixty Gulf War veterans were contacted by telephone and invited to participate in a 15-minute survey about their experience seeking diagnosis and treatment for GWI. They were informed that the survey was voluntary and confidential, that it was not part of the research trial in which they had been enrolled, and that their participation would not affect compensation received from VA. Verbal consent was requested, and 30 veterans agreed to participate in the survey.
The survey included questions about the course of illness, disability and service connection status, HCPs seen, and suggestions for improvement in their care (Table 1). 
Results
Of the 30 veterans who participated in the survey, most were male with only 2 female veterans. This proportion of female veterans (7%) is similar to the overall percentage of female veterans (6.7%) of the first Gulf War.2 Ages ranged from 46 to 66 years with a mean age of 53. Mean duration of illness, defined as time elapsed since perceived onset of chronic systemic symptoms during or after deployment, was 22.8 years, with a range of 4 to 27 years. Most respondents reported symptom onset within a few years after the end of the conflict, while a few reported the onset within weeks of arriving in the Kuwaiti theater of operations. A little more than half the respondents considered themselves disabled due to their symptoms, while one-third reported losing the ability to work due to symptoms. Respondents described needing to reduce hours, retire early, or stop working altogether because of their symptoms.
Respondents attributed several common chronic symptoms to deployment in the Gulf Wars (Table 2). 
Most veterans surveyed were service connected for individual chronic symptoms. Some were service connected for systemic conditions such as fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS) (5 veterans were connected for each condition). Three of the 30 veterans had been diagnosed with GWI—2 by past VA physicians and 1 by a physician at a GWI research center in another state. Of those 3, only 1 was service connected for the condition. Three respondents were not service connected at all.
The most common VA HCPs seen were in primary care and neurology followed by psychiatry and psychology. Of non-VA HCPs, most respondents saw primary care providers (PCPs) followed by chiropractors (Table 4). 
Before taking the Gulf War survey, a broad subjective question was posed. Respondents were asked whether VA HCPs were “supportive as you sought care for chronic postdeployment symptoms.” A majority of veterans reported that their VA HCPs were supportive. Reasons veterans gave for VA HCPs lack of support included feeling that HCPs did not believe them or trust their reported symptoms; did not care about their symptoms; refused to attribute their symptoms to Gulf War deployment; attributed symptoms to mental health issues; focused on doing things a certain way; or did not have the tools or information necessary to help.
Most non-VA HCPs were supportive. Reasons community HCPs were not supportive included “not looking at the whole picture,” not knowing veteran issues, not feeling comfortable with GWI, or not having much they could do.
Veterans were then asked whether they felt their HCPs were knowledgeable about GWI, and 13 respondents reported that their HCP was knowledgeable. Reasons respondents felt VA HCPs were not knowledgeable included denying that GWI exists, attributing symptoms to other conditions, not being aware of or familiar with GWI, needing education from the veteran, avoiding discussion about GWI or not caring to learn, or not knowing the latest research evidence to talk about GWI with authority. Compared with VA HCPs, veterans found community HCPs about half as likely to be knowledgeable about GWI. Many reported that community HCPs had not heard of GWI or had no knowledge about it.
Respondents also were asked what types of treatments they tried in order to typify the care received. The most common responses were pain medications, symptom-specific treatments, or “just putting up with it” (no treatment). Many patients were also self-medicating, trying lifestyle changes, or seeking alternative therapies.
Finally, respondents were asked on a scale of 0 (very unsatisfied) to 5 (very satisfied), how satisfied they were with their overall care at the VA. The majority were satisfied with their overall care, with two-thirds very satisfied (5 of 5) or pretty satisfied (4 of 5). Only 3 (10%) were unsatisfied or very unsatisfied. Respondents had the following comments about their care: “They treat me like I am important;” “I am very thankful even though they cannot figure it out;” “They are doing the best they can with no answers and not enough help;” “[I know] it is still a work in progress.” A number of respondents were satisfied with some HCPs or care for some but not all of their symptoms. Reasons respondents were less satisfied included desiring answers, feeling they were not respected, or feeling that their concerns were not addressed.
When asked for suggestions for improvement of GWI care, the most common response was providing up-to-date HCP education (Table 5). 
Discussion
The veterans participating in this QI survey had similar demographics, symptomology, and exposures as did those in other studies.1-7 Therefore, improvements based on their responses are likely applicable to the health care of veterans experiencing GWI-associated symptoms at other VA health care systems as well.
Veterans with GWI can lose significant functional capacity and productivity due to their symptoms. The symptoms are chronic and have afflicted many Gulf War veterans for nearly 3 decades. Furthermore, the prevalence of GWI in Gulf War veterans continues to increase.5-7 These facts testify to the enormous health-related quality-of-life impact of GWI.
Veterans who meet the Kansas case definition for GWI were not diagnosed or service connected in a uniform manner. Only 3 of the 30 veterans in this study were given a unifying diagnosis that connected their chronic illness to Gulf War deployment. Under current guidelines, Gulf War veterans are able to receive compensation for chronic symptoms in 3 ways: (1) compensation for chronic unexplained symptoms existing for ≥ 6 months that appeared during active duty in the Southwest Asia theater or by December 31, 2021, and are ≥ 10% disabling; (2) the 1995 Persian Gulf War Veterans’ Act recognizes 3 multisymptom illnesses for which veterans can be service connected: FM, CFS, and functional GI disorders, including IBS; and (3) expansion to include any CMI of unknown etiology is underway. A uniform diagnostic protocol based on biomarkers and updated understanding of disease pathology would be helpful.
Respondents shared experiences that demonstrated perceived gaps in HCP support or knowledge. Overall, more respondents found their HCPs supportive. Many of the reasons respondents found HCPs unsupportive related to acknowledgment of symptoms. Also, more respondents found that both VA and non-VA HCPs lacked knowledge about GWI symptoms. These findings further highlight the need for HCP education within the VA and in community-based care.
The treatments tried by respondents also highlight potential areas for improvement. Most of the treatments were for pain; therefore, more involvement with pain clinics and specialists could be helpful. Symptom-specific medications also are appropriate, although only one-third of patients reported use. While medications are not necessarily markers of quality care, the fact that many patients self-medicate or go without treatment suggests that access to care could be improved. In 2014, the VA and the US Department of Defense (DoD) released the “VA/DoD Clinical Practice Guideline for the Management of Chronic Multisymptom Illness,” which recommended treatments for the global disease and specific symptoms.15
Since then, GWI research points to inflammatory and metabolic disease mechanisms.11-14,16 As the underlying pathophysiology is further elucidated, practice guidelines will need to be updated to include anti-inflammatory and antioxidant treatments used in practice for GWI and similar chronic systemic illnesses (eg, CFS, FM, and IBS).17-19
Randomized control trials are needed to determine the efficacy of such medications for the treatment of GWI. As new results emerge, disseminating and updating evidence-based guidelines in a coordinated manner will be required for veterans to receive appropriate treatment. Veterans also seek alternative or nonpharmaceutical interventions, such as physical therapy and diet changes. Improving access to integrative medicine, physical therapy, nutritionists, and other practitioners also could optimize veterans’ health and function.
HCP Education
The Gulf War veteran respondents who participated in the survey noted HCP education, research progress, and veteran inclusion as areas for improvement. Respondents requested dissemination of information on diagnosis and treatment of GWI for HCPs and updates on research and other actions. They suggested ways research could be more effective (such as subgrouping by exposure, which researchers have been doing) and could extend to veterans experiencing CMI from other conflicts as well.20 Respondents also recommended team approaches or centers of excellence in order to receive more comprehensive care.
An asset of VHA is the culture of QI and education. The VA Employee Education System previously produced “Caring for Gulf War I Veterans,” a systemwide training module.21 In 2014, updated clinical practice guidelines for GWI were provided by the VA and the DoD, including evidence for each recommendation. In 2016, the VA in collaboration with the IOM produced a report summarizing conclusions and recommendations regarding associations between health concerns and Gulf War deployment.22 A concise guide for HCPs caring for veterans with GWI, updated in 2018, is available.23 Updated treatment guidelines, based on evolving understanding of GWI pathophysiology, and continuing efforts to disseminate information will be essential.
Respondents most often presented to primary care, both within and outside of MVAHCS. Therefore, VA and community PCPs who see veterans should be equipped to recognize and diagnose GWI as well as be familiar with basic disease management and specialists whom they could refer their patients. Neurology was the second most common specialty seen by respondents. The most prominent symptoms of GWI are related to nervous system function in addition to evidence of underlying neuroinflammation.20 Veterans may present to a neurologist with a variety of concerns, such as cognitive issues, sleep problems, migraines and headaches, and pain. Neurologists could best manage treatments targeting common neurologic GWI symptoms and neuroinflammation, especially as new treatments are discovered.
The next 2 most common specialty services seen were psychiatry and psychology (7 responses for each). Five respondents reported mental health issues as part of their chronic postdeployment symptoms. Population-based studies have indicated that rates of PTSD in Gulf War veterans is 3% to 6%, much lower than the prevalence of GWI.8,20 The 2010 IOM study concluded that GWI symptoms cannot be ascribed to any known psychiatric disorder. Unfortunately, several surveyed veterans made it clear that they had been denied care due to HCPs attributing their symptoms solely to mental health issues. Therefore, psychiatrists and psychologists must be educated about GWI, mental health issues occurring in Gulf War veterans, and physiologic symptoms of GWI that may mimic or coincide with mental health issues. These HCPs also would be important to include in an interdisciplinary clinic for veterans with GWI.
Finally, respondents sought care from numerous other specialties, including gastroenterology, physical therapy, pulmonology, dermatology, and surgical subspecialties, such as orthopedics and otolaryngology. This wide range of specialists seen emphasizes the need for medical education, beginning in medical school. If provided education on GWI, these specialists would be able to treat veterans with GWI, know to look for updates on GWI management, or know to look for other common symptoms, such as chronic sinusitis in otolaryngology or recurring rashes in dermatology. We also recommend identifying HCPs in these specialties who could be part of an interdisciplinary clinic or be referrals for symptom management.
Protocol Implementation
HCP education and clinical care protocol implementation should be the initial focus of improving GWI management. A team of stakeholders within the different areas of MVAHCS, including education, HCPs, and administrative staff, will need to be developed. Reaching out to VA HCPs who have seen veterans with GWI will be an essential first step to equip them with updated education about the diagnosis and management of CMI. Providing integrated widespread education to current HCPs who are likely to encounter veterans with deployment-related CMI from the Gulf War, OND/OEF/OIF, or other deployments also will be necessary. Finally, educating medical trainees, including residents and medical students, will ensure continuous care for future veterans, post-9/11 veterans.
GWI presentations at medical grand rounds or at other medical community educational events could provide educational outlets. These events create face-to-face opportunities to discuss GWI/CMI education with HCPs, giving them the opportunity to offer feedback about their experiences and create relationships with other HCPs who have seen patients with GWI/CMI. At an educational event, a short postevent feedback form that indicates whether HCPs would like more information or get involved in a clinic for veterans with CMI could be included. This information would help identify key HCPs and areas within the local VA needing further improvements, such as creating a clinic for veterans with GWI.
Since 1946, the VA has worked with academic institutions to provide state-of-the-art health care to US veterans and train new HCPs to meet the health care needs of the nation. Every year, > 40,000 residents and 20,000 medical students receive medical training at VA facilities, making VA the largest single provider of medical education in the country. Therefore, providing detailed GWI/CMI education to medical students and residents as a standard part of the VA Talent Management System would be of value for all VA professionals.
GWI Clinics
Access to comprehensive care can be accomplished by organizing a clinic for veterans with GWI. The most likely effective location would be in primary care. PCPs who have seen veterans with GWI and/or expressed interest in learning more about GWI will be the initial point of contact. As the primary care service has connections to ancillary services, such as pharmacists, dieticians, psychologists, and social workers, organizing 1 day each week to see patients with GWI would improve care.
As the need for specialty care arises, the team also would need to identify specialists willing to receive referrals from HCPs of veterans with GWI. These specialists could be identified via feedback forms from educational events, surveys after an online educational training, or through relationships among VA physicians. As the clinic becomes established, it may be effective to have certain commonly seen specialists available in person, most likely neurology, psychiatry, gastroenterology, pulmonology, and dermatology. Also, relationships with a pain clinic, sleep medicine, and integrative medicine services should be established.
Measures of improvement in the veteran health care experience could include veterans’ perceptions of the supportiveness and knowledge of physicians about GWI as well as overall satisfaction. A follow-up survey on these measures of veterans involved in a GWI clinic and those not involved would be a way to determine whether these clinics better meet veterans’ needs and what additional QI is needed.
Conclusion
A significant number of Gulf War veterans experience chronic postdeployment symptoms that need to be better addressed. Physicians need to be equipped to recognize and manage GWI and similar postdeployment CMI among veterans of OEF/OIF/OND. We recommend creating an educational initiative about GWI among VA physicians and trainees, connecting physicians who see veterans with GWI, and establishing an interdisciplinary clinic with a referral system as the next steps to improve care for veterans. An additional goal would be to reach out to veteran networks to update them on GWI research, education, and available health care, as veterans are the essential stakeholders in the QI process.
1. US Department of Veterans Affairs. Research Advisory Committee on Gulf War Veterans’ Illnesses. Gulf War Illness and the Health of Gulf War Veterans: Scientific Findings and Recommendations. https://www.va.gov/RAC-GWVI/docs/Committee_Documents/GWIandHealthofGWVeterans_RAC-GWVIReport_2008.pdf. Published November 2008. Accessed April 16, 2019.
2. Institute of Medicine. Gulf War and Health. Update of Health Effects of Serving in the Gulf War. Vol 8. Washington, DC: National Academies Press; 2009.
3. Fukuda K, Nisenbaum R, Stewart G, et al. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998;280(11):981-988.
4. Steele L. Prevalence and patterns of Gulf War illness in Kansas veterans: association of symptoms with characteristics of person, place, and time of military service. Am J Epidemiol. 2000;152(10):992-1002.
5. Kang HK, Mahan CM, Lee KY, Magee CA, Murphy FM. Illnesses among United States veterans of the Gulf War: a population-based survey of 30,000 veterans. J Occup Environ Med. 2000;42(5):491-501.
6. Kang HK, Li B, Mahan CM, Eisen SA, Engel CC. Health of US veterans of 1991 Gulf War: a follow-up survey in 10 years. J Occup Environ Med. 2009;51(4):401-410.
7. Dursa EK, Barth SK, Schneiderman AI, Bossarte RM. Physical and mental health status of Gulf War and Gulf era veterans: results from a large population-based epidemiological study. J Occup Environ Med. 2016;58(1):41-46.
8. Institute of Medicine. Gulf War and Health: Treatment for Chronic Multisymptom Illness. Washington, DC: National Academies Press; 2013.
9. Institute of Medicine. Chronic Multisymptom Illness in Gulf War Veterans: Case Definitions Reexamined. Washington, DC: National Academies Press; 2014.
10. United States Government Accountability Office. Gulf War illness: improvements needed for VA to better understand, process, and communicate decisions on claims. https://www.gao.gov/assets/690/685562.pdf. Published June 2017. Accessed April 16, 2019.
11. Johnson GJ, Slater BC, Leis LA, Rector TS, Bach RR. Blood biomarkers of chronic inflammation in Gulf War illness. PLoS One. 2016;11(6):e0157855.
12. Reno J. Gulf War veterans still fighting serious health problems. https://www.healthline.com/health-news/gulf-war-veterans-still-fighting-serious-health-problems#1. Published June 17, 2016. Accessed April 16, 2019.
13. McAndrew LM, Helmer DA, Phillips LA, Chandler HK, Ray K, Quigley KS. Iraq and Afghanistan veterans report symptoms consistent with chronic multisymptom illness one year after deployment. J Rehabil Res Dev. 2016;53(1):59-70.
14. Steele L, Sastre A, Gerkovich MM, Cook MR. Complex factors in the etiology of Gulf War illness: wartime exposures and risk factors in veteran subgroups. Environ Health Perspect. 2012;120(1):112-118.
15. US Department of Veterans Affairs. VA/DoD Clinical Practice Guideline for the Management of Chronic Multisymptom Illness. Version 2.0. https://www.healthquality.va.gov/guidelines/MR/cmi/VADoDCMICPG2014.pdf. Published October 2014. Accessed April 22, 2019.
16. Koslik HJ, Hamilton G, Golomb BA. Mitochondrial dysfunction in Gulf War illness revealed by 31phosphorus magnetic resonance spectroscopy: a case-control study. PLoS One. 2014;9(3):e92887.
17. Brewer KL, Mainhart A, Meggs WJ. Double-blinded placebo-controlled cross-over pilot trial of naltrexone to treat Gulf War illness. Fatigue: Biomed Health Behav. 2018;6(3):132-140.
18. Golomb BA, Allison M, Koperski S, Koslik HJ, Devaraj S, Ritchie JB. Coenzyme Q10 benefits symptoms in Gulf War veterans: results of a randomized double-blind study. Neural Comput. 2014;26(11):2594-2651.
19. Weiduschat N, Mao X, Vu D, et al. N-acetylcysteine alleviates cortical glutathione deficit and improves symptoms in CFS: an in vivo validation study using proton magnetic resonance spectroscopy. In: Proceedings from the IACFS/ME 12th Biennial Conference; October 27-30, 2016; Fort Lauderdale, FL. Abstract. http://iacfsme.org/ME-CFS-Primer-Education/News/IACFSME-2016-Program.aspx. Accessed April 22, 2019.
20. White RF, Steele L, O’Callaghan JP, et al. Recent research on Gulf War illness and other health problems in veterans of the 1991 Gulf War: effects of toxicant exposures during deployment. Cortex. 2016;74:449-475.
21. US Department of Veterans Affairs. Caring for Gulf War I Veterans. http://www.ngwrc.net/PDF%20Files/caring-for-gulf-war.pdf. Published July 2011. Accessed April 15, 2019.
22. National Academies of Sciences, Engineering, and Medicine. Gulf War and Health. Update of Serving in the Gulf War. Vol 10. Washington, DC: National Academies Press; 2016.
23. US Department of Veterans Affairs. War-Related Illness and Injury Study Center. Gulf War illness: a guide for veteran health care providers. https://www.warrelatedillness.va.gov/education/factsheets/gulf-war-illness-for-providers.pdf. Updated October 2018. Accessed April 16, 2019.
Many veterans of the Gulf War are experiencing deployment-related chronic illness, known as Gulf War illness (GWI). Symptoms of GWI include cognitive impairments (mood and memory), chronic fatigue, musculoskeletal pain, gastrointestinal (GI) disorders, respiratory problems, and skin rashes.1-4 Three survey studies of the physical and mental health of a large cohort of Gulf War and Gulf era veterans, conducted by the US Department of Veterans Affairs (VA) Office of Public Health, established the increased prevalence of GWI in the decades that followed the end of the conflict.5-7 Thus, GWI has become the signature adverse health-related outcome of the Gulf War. Quality improvement (QI) within the Veterans Health Administration (VHA) is needed in the diagnosis and treatment of GWI.
Background
GWI was first termed chronic multisymptom illness (CMI) by the Centers for Disease Control and Prevention (CDC). According to the CDC-10 case definition, CMI in veterans of the 1990-1991 Gulf War is defined as having ≥ 1 symptoms lasting ≥ 6 months in at least 2 of 3 categories: fatigue, depressed mood and altered cognition, and musculoskeletal pain.3 The Kansas case definition of GWI is more specific and is defined as having moderate-to-severe symptoms that are unexplained by any other diagnosis, in at least 3 of 6 categories: fatigue/sleep, somatic pain, neurologic/cognition/mood, GI, respiratory, and skin.4 Although chronic unexplained symptoms have occurred after other modern conflicts, the prevalence of GWI among Gulf War veterans has proven higher than those of prior conflicts.8
The Persian Gulf War Veterans Act of 1998 and the Veterans Programs Enhancement Act of 1998 mandated studies by the Institute of Medicine (IOM) on the biologic and chemical exposures that may have contributed to illness in the Kuwaiti theater of operations.9 However, elucidating the etiology and underlying pathophysiology of GWI has been a major research challenge. In the absence of objective diagnostic measures, an understanding of the fundamental pathophysiology, evidence-based treatments, a single case definition, and definitive guidelines for health care providers (HCPs) for the diagnosis and management of GWI has not been produced. As a result, veterans with GWI have struggled for nearly 3 decades to find a consistent diagnosis of and an effective treatment for their condition.
According to a report by the Government Accountability Office (GAO), the VA approved only 17% of claims for compensation for veterans with GWI from 2011 to 2015, about one-third the level of approval for all other claimed disabilities.10 Although the VA applied GAO recommendations to improve the compensation process, many veterans consider that their illness is treated as psychosomatic in clinical practice, despite emerging evidence of GWI-associated biomarkers.11 Others think they have been forgotten due to their short 1-year period of service in the Gulf War.12 To realign research, guidelines, clinical care, and the health care experience of veterans with GWI, focused QI within VHA is urgently needed.
Veterans of Operations Enduring Freedom, Iraqi Freedom, and New Dawn (OEF/OIF/OND) are experiencing similar CMI symptoms. A study of US Army Reserve OEF/OIF veterans found that > 60% met the CDC-10 case definition for GWI 1-year postdeployment.13 Thus, CMI is emerging as a serious health problem for post-9/11 veterans. The evidence of postdeployment CMI among veterans of recent conflicts underscores the need to increase efforts at a national level, beginning with the VHA. This report includes a summary of Gulf War veterans’ experiences at the Minneapolis VA Health Care System (MVAHCS) and a proposal for QI of MVAHCS processes focused on HCP education and clinical care.
Methods
To determine areas of GWI health care that needed QI at the MVAHCS, veterans with GWI were contacted for a telephone survey. These veterans had participated in the Gulf War Illness Inflammation Reduction Trial (ClinicalTrials.gov. Identifier: NCT02506192). Therefore, all met the Kansas case definition for GWI.4 The aim of the survey was to characterize veterans’ experiences seeking health care for chronic postdeployment symptoms.
Sixty Gulf War veterans were contacted by telephone and invited to participate in a 15-minute survey about their experience seeking diagnosis and treatment for GWI. They were informed that the survey was voluntary and confidential, that it was not part of the research trial in which they had been enrolled, and that their participation would not affect compensation received from VA. Verbal consent was requested, and 30 veterans agreed to participate in the survey.
The survey included questions about the course of illness, disability and service connection status, HCPs seen, and suggestions for improvement in their care (Table 1).
Results
Of the 30 veterans who participated in the survey, most were male with only 2 female veterans. This proportion of female veterans (7%) is similar to the overall percentage of female veterans (6.7%) of the first Gulf War.2 Ages ranged from 46 to 66 years with a mean age of 53. Mean duration of illness, defined as time elapsed since perceived onset of chronic systemic symptoms during or after deployment, was 22.8 years, with a range of 4 to 27 years. Most respondents reported symptom onset within a few years after the end of the conflict, while a few reported the onset within weeks of arriving in the Kuwaiti theater of operations. A little more than half the respondents considered themselves disabled due to their symptoms, while one-third reported losing the ability to work due to symptoms. Respondents described needing to reduce hours, retire early, or stop working altogether because of their symptoms.
Respondents attributed several common chronic symptoms to deployment in the Gulf Wars (Table 2).
Most veterans surveyed were service connected for individual chronic symptoms. Some were service connected for systemic conditions such as fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS) (5 veterans were connected for each condition). Three of the 30 veterans had been diagnosed with GWI—2 by past VA physicians and 1 by a physician at a GWI research center in another state. Of those 3, only 1 was service connected for the condition. Three respondents were not service connected at all.
The most common VA HCPs seen were in primary care and neurology followed by psychiatry and psychology. Of non-VA HCPs, most respondents saw primary care providers (PCPs) followed by chiropractors (Table 4).
Before taking the Gulf War survey, a broad subjective question was posed. Respondents were asked whether VA HCPs were “supportive as you sought care for chronic postdeployment symptoms.” A majority of veterans reported that their VA HCPs were supportive. Reasons veterans gave for VA HCPs lack of support included feeling that HCPs did not believe them or trust their reported symptoms; did not care about their symptoms; refused to attribute their symptoms to Gulf War deployment; attributed symptoms to mental health issues; focused on doing things a certain way; or did not have the tools or information necessary to help.
Most non-VA HCPs were supportive. Reasons community HCPs were not supportive included “not looking at the whole picture,” not knowing veteran issues, not feeling comfortable with GWI, or not having much they could do.
Veterans were then asked whether they felt their HCPs were knowledgeable about GWI, and 13 respondents reported that their HCP was knowledgeable. Reasons respondents felt VA HCPs were not knowledgeable included denying that GWI exists, attributing symptoms to other conditions, not being aware of or familiar with GWI, needing education from the veteran, avoiding discussion about GWI or not caring to learn, or not knowing the latest research evidence to talk about GWI with authority. Compared with VA HCPs, veterans found community HCPs about half as likely to be knowledgeable about GWI. Many reported that community HCPs had not heard of GWI or had no knowledge about it.
Respondents also were asked what types of treatments they tried in order to typify the care received. The most common responses were pain medications, symptom-specific treatments, or “just putting up with it” (no treatment). Many patients were also self-medicating, trying lifestyle changes, or seeking alternative therapies.
Finally, respondents were asked on a scale of 0 (very unsatisfied) to 5 (very satisfied), how satisfied they were with their overall care at the VA. The majority were satisfied with their overall care, with two-thirds very satisfied (5 of 5) or pretty satisfied (4 of 5). Only 3 (10%) were unsatisfied or very unsatisfied. Respondents had the following comments about their care: “They treat me like I am important;” “I am very thankful even though they cannot figure it out;” “They are doing the best they can with no answers and not enough help;” “[I know] it is still a work in progress.” A number of respondents were satisfied with some HCPs or care for some but not all of their symptoms. Reasons respondents were less satisfied included desiring answers, feeling they were not respected, or feeling that their concerns were not addressed.
When asked for suggestions for improvement of GWI care, the most common response was providing up-to-date HCP education (Table 5).
Discussion
The veterans participating in this QI survey had similar demographics, symptomology, and exposures as did those in other studies.1-7 Therefore, improvements based on their responses are likely applicable to the health care of veterans experiencing GWI-associated symptoms at other VA health care systems as well.
Veterans with GWI can lose significant functional capacity and productivity due to their symptoms. The symptoms are chronic and have afflicted many Gulf War veterans for nearly 3 decades. Furthermore, the prevalence of GWI in Gulf War veterans continues to increase.5-7 These facts testify to the enormous health-related quality-of-life impact of GWI.
Veterans who meet the Kansas case definition for GWI were not diagnosed or service connected in a uniform manner. Only 3 of the 30 veterans in this study were given a unifying diagnosis that connected their chronic illness to Gulf War deployment. Under current guidelines, Gulf War veterans are able to receive compensation for chronic symptoms in 3 ways: (1) compensation for chronic unexplained symptoms existing for ≥ 6 months that appeared during active duty in the Southwest Asia theater or by December 31, 2021, and are ≥ 10% disabling; (2) the 1995 Persian Gulf War Veterans’ Act recognizes 3 multisymptom illnesses for which veterans can be service connected: FM, CFS, and functional GI disorders, including IBS; and (3) expansion to include any CMI of unknown etiology is underway. A uniform diagnostic protocol based on biomarkers and updated understanding of disease pathology would be helpful.
Respondents shared experiences that demonstrated perceived gaps in HCP support or knowledge. Overall, more respondents found their HCPs supportive. Many of the reasons respondents found HCPs unsupportive related to acknowledgment of symptoms. Also, more respondents found that both VA and non-VA HCPs lacked knowledge about GWI symptoms. These findings further highlight the need for HCP education within the VA and in community-based care.
The treatments tried by respondents also highlight potential areas for improvement. Most of the treatments were for pain; therefore, more involvement with pain clinics and specialists could be helpful. Symptom-specific medications also are appropriate, although only one-third of patients reported use. While medications are not necessarily markers of quality care, the fact that many patients self-medicate or go without treatment suggests that access to care could be improved. In 2014, the VA and the US Department of Defense (DoD) released the “VA/DoD Clinical Practice Guideline for the Management of Chronic Multisymptom Illness,” which recommended treatments for the global disease and specific symptoms.15
Since then, GWI research points to inflammatory and metabolic disease mechanisms.11-14,16 As the underlying pathophysiology is further elucidated, practice guidelines will need to be updated to include anti-inflammatory and antioxidant treatments used in practice for GWI and similar chronic systemic illnesses (eg, CFS, FM, and IBS).17-19
Randomized control trials are needed to determine the efficacy of such medications for the treatment of GWI. As new results emerge, disseminating and updating evidence-based guidelines in a coordinated manner will be required for veterans to receive appropriate treatment. Veterans also seek alternative or nonpharmaceutical interventions, such as physical therapy and diet changes. Improving access to integrative medicine, physical therapy, nutritionists, and other practitioners also could optimize veterans’ health and function.
HCP Education
The Gulf War veteran respondents who participated in the survey noted HCP education, research progress, and veteran inclusion as areas for improvement. Respondents requested dissemination of information on diagnosis and treatment of GWI for HCPs and updates on research and other actions. They suggested ways research could be more effective (such as subgrouping by exposure, which researchers have been doing) and could extend to veterans experiencing CMI from other conflicts as well.20 Respondents also recommended team approaches or centers of excellence in order to receive more comprehensive care.
An asset of VHA is the culture of QI and education. The VA Employee Education System previously produced “Caring for Gulf War I Veterans,” a systemwide training module.21 In 2014, updated clinical practice guidelines for GWI were provided by the VA and the DoD, including evidence for each recommendation. In 2016, the VA in collaboration with the IOM produced a report summarizing conclusions and recommendations regarding associations between health concerns and Gulf War deployment.22 A concise guide for HCPs caring for veterans with GWI, updated in 2018, is available.23 Updated treatment guidelines, based on evolving understanding of GWI pathophysiology, and continuing efforts to disseminate information will be essential.
Respondents most often presented to primary care, both within and outside of MVAHCS. Therefore, VA and community PCPs who see veterans should be equipped to recognize and diagnose GWI as well as be familiar with basic disease management and specialists whom they could refer their patients. Neurology was the second most common specialty seen by respondents. The most prominent symptoms of GWI are related to nervous system function in addition to evidence of underlying neuroinflammation.20 Veterans may present to a neurologist with a variety of concerns, such as cognitive issues, sleep problems, migraines and headaches, and pain. Neurologists could best manage treatments targeting common neurologic GWI symptoms and neuroinflammation, especially as new treatments are discovered.
The next 2 most common specialty services seen were psychiatry and psychology (7 responses for each). Five respondents reported mental health issues as part of their chronic postdeployment symptoms. Population-based studies have indicated that rates of PTSD in Gulf War veterans is 3% to 6%, much lower than the prevalence of GWI.8,20 The 2010 IOM study concluded that GWI symptoms cannot be ascribed to any known psychiatric disorder. Unfortunately, several surveyed veterans made it clear that they had been denied care due to HCPs attributing their symptoms solely to mental health issues. Therefore, psychiatrists and psychologists must be educated about GWI, mental health issues occurring in Gulf War veterans, and physiologic symptoms of GWI that may mimic or coincide with mental health issues. These HCPs also would be important to include in an interdisciplinary clinic for veterans with GWI.
Finally, respondents sought care from numerous other specialties, including gastroenterology, physical therapy, pulmonology, dermatology, and surgical subspecialties, such as orthopedics and otolaryngology. This wide range of specialists seen emphasizes the need for medical education, beginning in medical school. If provided education on GWI, these specialists would be able to treat veterans with GWI, know to look for updates on GWI management, or know to look for other common symptoms, such as chronic sinusitis in otolaryngology or recurring rashes in dermatology. We also recommend identifying HCPs in these specialties who could be part of an interdisciplinary clinic or be referrals for symptom management.
Protocol Implementation
HCP education and clinical care protocol implementation should be the initial focus of improving GWI management. A team of stakeholders within the different areas of MVAHCS, including education, HCPs, and administrative staff, will need to be developed. Reaching out to VA HCPs who have seen veterans with GWI will be an essential first step to equip them with updated education about the diagnosis and management of CMI. Providing integrated widespread education to current HCPs who are likely to encounter veterans with deployment-related CMI from the Gulf War, OND/OEF/OIF, or other deployments also will be necessary. Finally, educating medical trainees, including residents and medical students, will ensure continuous care for future veterans, post-9/11 veterans.
GWI presentations at medical grand rounds or at other medical community educational events could provide educational outlets. These events create face-to-face opportunities to discuss GWI/CMI education with HCPs, giving them the opportunity to offer feedback about their experiences and create relationships with other HCPs who have seen patients with GWI/CMI. At an educational event, a short postevent feedback form that indicates whether HCPs would like more information or get involved in a clinic for veterans with CMI could be included. This information would help identify key HCPs and areas within the local VA needing further improvements, such as creating a clinic for veterans with GWI.
Since 1946, the VA has worked with academic institutions to provide state-of-the-art health care to US veterans and train new HCPs to meet the health care needs of the nation. Every year, > 40,000 residents and 20,000 medical students receive medical training at VA facilities, making VA the largest single provider of medical education in the country. Therefore, providing detailed GWI/CMI education to medical students and residents as a standard part of the VA Talent Management System would be of value for all VA professionals.
GWI Clinics
Access to comprehensive care can be accomplished by organizing a clinic for veterans with GWI. The most likely effective location would be in primary care. PCPs who have seen veterans with GWI and/or expressed interest in learning more about GWI will be the initial point of contact. As the primary care service has connections to ancillary services, such as pharmacists, dieticians, psychologists, and social workers, organizing 1 day each week to see patients with GWI would improve care.
As the need for specialty care arises, the team also would need to identify specialists willing to receive referrals from HCPs of veterans with GWI. These specialists could be identified via feedback forms from educational events, surveys after an online educational training, or through relationships among VA physicians. As the clinic becomes established, it may be effective to have certain commonly seen specialists available in person, most likely neurology, psychiatry, gastroenterology, pulmonology, and dermatology. Also, relationships with a pain clinic, sleep medicine, and integrative medicine services should be established.
Measures of improvement in the veteran health care experience could include veterans’ perceptions of the supportiveness and knowledge of physicians about GWI as well as overall satisfaction. A follow-up survey on these measures of veterans involved in a GWI clinic and those not involved would be a way to determine whether these clinics better meet veterans’ needs and what additional QI is needed.
Conclusion
A significant number of Gulf War veterans experience chronic postdeployment symptoms that need to be better addressed. Physicians need to be equipped to recognize and manage GWI and similar postdeployment CMI among veterans of OEF/OIF/OND. We recommend creating an educational initiative about GWI among VA physicians and trainees, connecting physicians who see veterans with GWI, and establishing an interdisciplinary clinic with a referral system as the next steps to improve care for veterans. An additional goal would be to reach out to veteran networks to update them on GWI research, education, and available health care, as veterans are the essential stakeholders in the QI process.
Many veterans of the Gulf War are experiencing deployment-related chronic illness, known as Gulf War illness (GWI). Symptoms of GWI include cognitive impairments (mood and memory), chronic fatigue, musculoskeletal pain, gastrointestinal (GI) disorders, respiratory problems, and skin rashes.1-4 Three survey studies of the physical and mental health of a large cohort of Gulf War and Gulf era veterans, conducted by the US Department of Veterans Affairs (VA) Office of Public Health, established the increased prevalence of GWI in the decades that followed the end of the conflict.5-7 Thus, GWI has become the signature adverse health-related outcome of the Gulf War. Quality improvement (QI) within the Veterans Health Administration (VHA) is needed in the diagnosis and treatment of GWI.
Background
GWI was first termed chronic multisymptom illness (CMI) by the Centers for Disease Control and Prevention (CDC). According to the CDC-10 case definition, CMI in veterans of the 1990-1991 Gulf War is defined as having ≥ 1 symptoms lasting ≥ 6 months in at least 2 of 3 categories: fatigue, depressed mood and altered cognition, and musculoskeletal pain.3 The Kansas case definition of GWI is more specific and is defined as having moderate-to-severe symptoms that are unexplained by any other diagnosis, in at least 3 of 6 categories: fatigue/sleep, somatic pain, neurologic/cognition/mood, GI, respiratory, and skin.4 Although chronic unexplained symptoms have occurred after other modern conflicts, the prevalence of GWI among Gulf War veterans has proven higher than those of prior conflicts.8
The Persian Gulf War Veterans Act of 1998 and the Veterans Programs Enhancement Act of 1998 mandated studies by the Institute of Medicine (IOM) on the biologic and chemical exposures that may have contributed to illness in the Kuwaiti theater of operations.9 However, elucidating the etiology and underlying pathophysiology of GWI has been a major research challenge. In the absence of objective diagnostic measures, an understanding of the fundamental pathophysiology, evidence-based treatments, a single case definition, and definitive guidelines for health care providers (HCPs) for the diagnosis and management of GWI has not been produced. As a result, veterans with GWI have struggled for nearly 3 decades to find a consistent diagnosis of and an effective treatment for their condition.
According to a report by the Government Accountability Office (GAO), the VA approved only 17% of claims for compensation for veterans with GWI from 2011 to 2015, about one-third the level of approval for all other claimed disabilities.10 Although the VA applied GAO recommendations to improve the compensation process, many veterans consider that their illness is treated as psychosomatic in clinical practice, despite emerging evidence of GWI-associated biomarkers.11 Others think they have been forgotten due to their short 1-year period of service in the Gulf War.12 To realign research, guidelines, clinical care, and the health care experience of veterans with GWI, focused QI within VHA is urgently needed.
Veterans of Operations Enduring Freedom, Iraqi Freedom, and New Dawn (OEF/OIF/OND) are experiencing similar CMI symptoms. A study of US Army Reserve OEF/OIF veterans found that > 60% met the CDC-10 case definition for GWI 1-year postdeployment.13 Thus, CMI is emerging as a serious health problem for post-9/11 veterans. The evidence of postdeployment CMI among veterans of recent conflicts underscores the need to increase efforts at a national level, beginning with the VHA. This report includes a summary of Gulf War veterans’ experiences at the Minneapolis VA Health Care System (MVAHCS) and a proposal for QI of MVAHCS processes focused on HCP education and clinical care.
Methods
To determine areas of GWI health care that needed QI at the MVAHCS, veterans with GWI were contacted for a telephone survey. These veterans had participated in the Gulf War Illness Inflammation Reduction Trial (ClinicalTrials.gov. Identifier: NCT02506192). Therefore, all met the Kansas case definition for GWI.4 The aim of the survey was to characterize veterans’ experiences seeking health care for chronic postdeployment symptoms.
Sixty Gulf War veterans were contacted by telephone and invited to participate in a 15-minute survey about their experience seeking diagnosis and treatment for GWI. They were informed that the survey was voluntary and confidential, that it was not part of the research trial in which they had been enrolled, and that their participation would not affect compensation received from VA. Verbal consent was requested, and 30 veterans agreed to participate in the survey.
The survey included questions about the course of illness, disability and service connection status, HCPs seen, and suggestions for improvement in their care (Table 1).
Results
Of the 30 veterans who participated in the survey, most were male with only 2 female veterans. This proportion of female veterans (7%) is similar to the overall percentage of female veterans (6.7%) of the first Gulf War.2 Ages ranged from 46 to 66 years with a mean age of 53. Mean duration of illness, defined as time elapsed since perceived onset of chronic systemic symptoms during or after deployment, was 22.8 years, with a range of 4 to 27 years. Most respondents reported symptom onset within a few years after the end of the conflict, while a few reported the onset within weeks of arriving in the Kuwaiti theater of operations. A little more than half the respondents considered themselves disabled due to their symptoms, while one-third reported losing the ability to work due to symptoms. Respondents described needing to reduce hours, retire early, or stop working altogether because of their symptoms.
Respondents attributed several common chronic symptoms to deployment in the Gulf Wars (Table 2).
Most veterans surveyed were service connected for individual chronic symptoms. Some were service connected for systemic conditions such as fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS) (5 veterans were connected for each condition). Three of the 30 veterans had been diagnosed with GWI—2 by past VA physicians and 1 by a physician at a GWI research center in another state. Of those 3, only 1 was service connected for the condition. Three respondents were not service connected at all.
The most common VA HCPs seen were in primary care and neurology followed by psychiatry and psychology. Of non-VA HCPs, most respondents saw primary care providers (PCPs) followed by chiropractors (Table 4).
Before taking the Gulf War survey, a broad subjective question was posed. Respondents were asked whether VA HCPs were “supportive as you sought care for chronic postdeployment symptoms.” A majority of veterans reported that their VA HCPs were supportive. Reasons veterans gave for VA HCPs lack of support included feeling that HCPs did not believe them or trust their reported symptoms; did not care about their symptoms; refused to attribute their symptoms to Gulf War deployment; attributed symptoms to mental health issues; focused on doing things a certain way; or did not have the tools or information necessary to help.
Most non-VA HCPs were supportive. Reasons community HCPs were not supportive included “not looking at the whole picture,” not knowing veteran issues, not feeling comfortable with GWI, or not having much they could do.
Veterans were then asked whether they felt their HCPs were knowledgeable about GWI, and 13 respondents reported that their HCP was knowledgeable. Reasons respondents felt VA HCPs were not knowledgeable included denying that GWI exists, attributing symptoms to other conditions, not being aware of or familiar with GWI, needing education from the veteran, avoiding discussion about GWI or not caring to learn, or not knowing the latest research evidence to talk about GWI with authority. Compared with VA HCPs, veterans found community HCPs about half as likely to be knowledgeable about GWI. Many reported that community HCPs had not heard of GWI or had no knowledge about it.
Respondents also were asked what types of treatments they tried in order to typify the care received. The most common responses were pain medications, symptom-specific treatments, or “just putting up with it” (no treatment). Many patients were also self-medicating, trying lifestyle changes, or seeking alternative therapies.
Finally, respondents were asked on a scale of 0 (very unsatisfied) to 5 (very satisfied), how satisfied they were with their overall care at the VA. The majority were satisfied with their overall care, with two-thirds very satisfied (5 of 5) or pretty satisfied (4 of 5). Only 3 (10%) were unsatisfied or very unsatisfied. Respondents had the following comments about their care: “They treat me like I am important;” “I am very thankful even though they cannot figure it out;” “They are doing the best they can with no answers and not enough help;” “[I know] it is still a work in progress.” A number of respondents were satisfied with some HCPs or care for some but not all of their symptoms. Reasons respondents were less satisfied included desiring answers, feeling they were not respected, or feeling that their concerns were not addressed.
When asked for suggestions for improvement of GWI care, the most common response was providing up-to-date HCP education (Table 5).
Discussion
The veterans participating in this QI survey had similar demographics, symptomology, and exposures as did those in other studies.1-7 Therefore, improvements based on their responses are likely applicable to the health care of veterans experiencing GWI-associated symptoms at other VA health care systems as well.
Veterans with GWI can lose significant functional capacity and productivity due to their symptoms. The symptoms are chronic and have afflicted many Gulf War veterans for nearly 3 decades. Furthermore, the prevalence of GWI in Gulf War veterans continues to increase.5-7 These facts testify to the enormous health-related quality-of-life impact of GWI.
Veterans who meet the Kansas case definition for GWI were not diagnosed or service connected in a uniform manner. Only 3 of the 30 veterans in this study were given a unifying diagnosis that connected their chronic illness to Gulf War deployment. Under current guidelines, Gulf War veterans are able to receive compensation for chronic symptoms in 3 ways: (1) compensation for chronic unexplained symptoms existing for ≥ 6 months that appeared during active duty in the Southwest Asia theater or by December 31, 2021, and are ≥ 10% disabling; (2) the 1995 Persian Gulf War Veterans’ Act recognizes 3 multisymptom illnesses for which veterans can be service connected: FM, CFS, and functional GI disorders, including IBS; and (3) expansion to include any CMI of unknown etiology is underway. A uniform diagnostic protocol based on biomarkers and updated understanding of disease pathology would be helpful.
Respondents shared experiences that demonstrated perceived gaps in HCP support or knowledge. Overall, more respondents found their HCPs supportive. Many of the reasons respondents found HCPs unsupportive related to acknowledgment of symptoms. Also, more respondents found that both VA and non-VA HCPs lacked knowledge about GWI symptoms. These findings further highlight the need for HCP education within the VA and in community-based care.
The treatments tried by respondents also highlight potential areas for improvement. Most of the treatments were for pain; therefore, more involvement with pain clinics and specialists could be helpful. Symptom-specific medications also are appropriate, although only one-third of patients reported use. While medications are not necessarily markers of quality care, the fact that many patients self-medicate or go without treatment suggests that access to care could be improved. In 2014, the VA and the US Department of Defense (DoD) released the “VA/DoD Clinical Practice Guideline for the Management of Chronic Multisymptom Illness,” which recommended treatments for the global disease and specific symptoms.15
Since then, GWI research points to inflammatory and metabolic disease mechanisms.11-14,16 As the underlying pathophysiology is further elucidated, practice guidelines will need to be updated to include anti-inflammatory and antioxidant treatments used in practice for GWI and similar chronic systemic illnesses (eg, CFS, FM, and IBS).17-19
Randomized control trials are needed to determine the efficacy of such medications for the treatment of GWI. As new results emerge, disseminating and updating evidence-based guidelines in a coordinated manner will be required for veterans to receive appropriate treatment. Veterans also seek alternative or nonpharmaceutical interventions, such as physical therapy and diet changes. Improving access to integrative medicine, physical therapy, nutritionists, and other practitioners also could optimize veterans’ health and function.
HCP Education
The Gulf War veteran respondents who participated in the survey noted HCP education, research progress, and veteran inclusion as areas for improvement. Respondents requested dissemination of information on diagnosis and treatment of GWI for HCPs and updates on research and other actions. They suggested ways research could be more effective (such as subgrouping by exposure, which researchers have been doing) and could extend to veterans experiencing CMI from other conflicts as well.20 Respondents also recommended team approaches or centers of excellence in order to receive more comprehensive care.
An asset of VHA is the culture of QI and education. The VA Employee Education System previously produced “Caring for Gulf War I Veterans,” a systemwide training module.21 In 2014, updated clinical practice guidelines for GWI were provided by the VA and the DoD, including evidence for each recommendation. In 2016, the VA in collaboration with the IOM produced a report summarizing conclusions and recommendations regarding associations between health concerns and Gulf War deployment.22 A concise guide for HCPs caring for veterans with GWI, updated in 2018, is available.23 Updated treatment guidelines, based on evolving understanding of GWI pathophysiology, and continuing efforts to disseminate information will be essential.
Respondents most often presented to primary care, both within and outside of MVAHCS. Therefore, VA and community PCPs who see veterans should be equipped to recognize and diagnose GWI as well as be familiar with basic disease management and specialists whom they could refer their patients. Neurology was the second most common specialty seen by respondents. The most prominent symptoms of GWI are related to nervous system function in addition to evidence of underlying neuroinflammation.20 Veterans may present to a neurologist with a variety of concerns, such as cognitive issues, sleep problems, migraines and headaches, and pain. Neurologists could best manage treatments targeting common neurologic GWI symptoms and neuroinflammation, especially as new treatments are discovered.
The next 2 most common specialty services seen were psychiatry and psychology (7 responses for each). Five respondents reported mental health issues as part of their chronic postdeployment symptoms. Population-based studies have indicated that rates of PTSD in Gulf War veterans is 3% to 6%, much lower than the prevalence of GWI.8,20 The 2010 IOM study concluded that GWI symptoms cannot be ascribed to any known psychiatric disorder. Unfortunately, several surveyed veterans made it clear that they had been denied care due to HCPs attributing their symptoms solely to mental health issues. Therefore, psychiatrists and psychologists must be educated about GWI, mental health issues occurring in Gulf War veterans, and physiologic symptoms of GWI that may mimic or coincide with mental health issues. These HCPs also would be important to include in an interdisciplinary clinic for veterans with GWI.
Finally, respondents sought care from numerous other specialties, including gastroenterology, physical therapy, pulmonology, dermatology, and surgical subspecialties, such as orthopedics and otolaryngology. This wide range of specialists seen emphasizes the need for medical education, beginning in medical school. If provided education on GWI, these specialists would be able to treat veterans with GWI, know to look for updates on GWI management, or know to look for other common symptoms, such as chronic sinusitis in otolaryngology or recurring rashes in dermatology. We also recommend identifying HCPs in these specialties who could be part of an interdisciplinary clinic or be referrals for symptom management.
Protocol Implementation
HCP education and clinical care protocol implementation should be the initial focus of improving GWI management. A team of stakeholders within the different areas of MVAHCS, including education, HCPs, and administrative staff, will need to be developed. Reaching out to VA HCPs who have seen veterans with GWI will be an essential first step to equip them with updated education about the diagnosis and management of CMI. Providing integrated widespread education to current HCPs who are likely to encounter veterans with deployment-related CMI from the Gulf War, OND/OEF/OIF, or other deployments also will be necessary. Finally, educating medical trainees, including residents and medical students, will ensure continuous care for future veterans, post-9/11 veterans.
GWI presentations at medical grand rounds or at other medical community educational events could provide educational outlets. These events create face-to-face opportunities to discuss GWI/CMI education with HCPs, giving them the opportunity to offer feedback about their experiences and create relationships with other HCPs who have seen patients with GWI/CMI. At an educational event, a short postevent feedback form that indicates whether HCPs would like more information or get involved in a clinic for veterans with CMI could be included. This information would help identify key HCPs and areas within the local VA needing further improvements, such as creating a clinic for veterans with GWI.
Since 1946, the VA has worked with academic institutions to provide state-of-the-art health care to US veterans and train new HCPs to meet the health care needs of the nation. Every year, > 40,000 residents and 20,000 medical students receive medical training at VA facilities, making VA the largest single provider of medical education in the country. Therefore, providing detailed GWI/CMI education to medical students and residents as a standard part of the VA Talent Management System would be of value for all VA professionals.
GWI Clinics
Access to comprehensive care can be accomplished by organizing a clinic for veterans with GWI. The most likely effective location would be in primary care. PCPs who have seen veterans with GWI and/or expressed interest in learning more about GWI will be the initial point of contact. As the primary care service has connections to ancillary services, such as pharmacists, dieticians, psychologists, and social workers, organizing 1 day each week to see patients with GWI would improve care.
As the need for specialty care arises, the team also would need to identify specialists willing to receive referrals from HCPs of veterans with GWI. These specialists could be identified via feedback forms from educational events, surveys after an online educational training, or through relationships among VA physicians. As the clinic becomes established, it may be effective to have certain commonly seen specialists available in person, most likely neurology, psychiatry, gastroenterology, pulmonology, and dermatology. Also, relationships with a pain clinic, sleep medicine, and integrative medicine services should be established.
Measures of improvement in the veteran health care experience could include veterans’ perceptions of the supportiveness and knowledge of physicians about GWI as well as overall satisfaction. A follow-up survey on these measures of veterans involved in a GWI clinic and those not involved would be a way to determine whether these clinics better meet veterans’ needs and what additional QI is needed.
Conclusion
A significant number of Gulf War veterans experience chronic postdeployment symptoms that need to be better addressed. Physicians need to be equipped to recognize and manage GWI and similar postdeployment CMI among veterans of OEF/OIF/OND. We recommend creating an educational initiative about GWI among VA physicians and trainees, connecting physicians who see veterans with GWI, and establishing an interdisciplinary clinic with a referral system as the next steps to improve care for veterans. An additional goal would be to reach out to veteran networks to update them on GWI research, education, and available health care, as veterans are the essential stakeholders in the QI process.
1. US Department of Veterans Affairs. Research Advisory Committee on Gulf War Veterans’ Illnesses. Gulf War Illness and the Health of Gulf War Veterans: Scientific Findings and Recommendations. https://www.va.gov/RAC-GWVI/docs/Committee_Documents/GWIandHealthofGWVeterans_RAC-GWVIReport_2008.pdf. Published November 2008. Accessed April 16, 2019.
2. Institute of Medicine. Gulf War and Health. Update of Health Effects of Serving in the Gulf War. Vol 8. Washington, DC: National Academies Press; 2009.
3. Fukuda K, Nisenbaum R, Stewart G, et al. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998;280(11):981-988.
4. Steele L. Prevalence and patterns of Gulf War illness in Kansas veterans: association of symptoms with characteristics of person, place, and time of military service. Am J Epidemiol. 2000;152(10):992-1002.
5. Kang HK, Mahan CM, Lee KY, Magee CA, Murphy FM. Illnesses among United States veterans of the Gulf War: a population-based survey of 30,000 veterans. J Occup Environ Med. 2000;42(5):491-501.
6. Kang HK, Li B, Mahan CM, Eisen SA, Engel CC. Health of US veterans of 1991 Gulf War: a follow-up survey in 10 years. J Occup Environ Med. 2009;51(4):401-410.
7. Dursa EK, Barth SK, Schneiderman AI, Bossarte RM. Physical and mental health status of Gulf War and Gulf era veterans: results from a large population-based epidemiological study. J Occup Environ Med. 2016;58(1):41-46.
8. Institute of Medicine. Gulf War and Health: Treatment for Chronic Multisymptom Illness. Washington, DC: National Academies Press; 2013.
9. Institute of Medicine. Chronic Multisymptom Illness in Gulf War Veterans: Case Definitions Reexamined. Washington, DC: National Academies Press; 2014.
10. United States Government Accountability Office. Gulf War illness: improvements needed for VA to better understand, process, and communicate decisions on claims. https://www.gao.gov/assets/690/685562.pdf. Published June 2017. Accessed April 16, 2019.
11. Johnson GJ, Slater BC, Leis LA, Rector TS, Bach RR. Blood biomarkers of chronic inflammation in Gulf War illness. PLoS One. 2016;11(6):e0157855.
12. Reno J. Gulf War veterans still fighting serious health problems. https://www.healthline.com/health-news/gulf-war-veterans-still-fighting-serious-health-problems#1. Published June 17, 2016. Accessed April 16, 2019.
13. McAndrew LM, Helmer DA, Phillips LA, Chandler HK, Ray K, Quigley KS. Iraq and Afghanistan veterans report symptoms consistent with chronic multisymptom illness one year after deployment. J Rehabil Res Dev. 2016;53(1):59-70.
14. Steele L, Sastre A, Gerkovich MM, Cook MR. Complex factors in the etiology of Gulf War illness: wartime exposures and risk factors in veteran subgroups. Environ Health Perspect. 2012;120(1):112-118.
15. US Department of Veterans Affairs. VA/DoD Clinical Practice Guideline for the Management of Chronic Multisymptom Illness. Version 2.0. https://www.healthquality.va.gov/guidelines/MR/cmi/VADoDCMICPG2014.pdf. Published October 2014. Accessed April 22, 2019.
16. Koslik HJ, Hamilton G, Golomb BA. Mitochondrial dysfunction in Gulf War illness revealed by 31phosphorus magnetic resonance spectroscopy: a case-control study. PLoS One. 2014;9(3):e92887.
17. Brewer KL, Mainhart A, Meggs WJ. Double-blinded placebo-controlled cross-over pilot trial of naltrexone to treat Gulf War illness. Fatigue: Biomed Health Behav. 2018;6(3):132-140.
18. Golomb BA, Allison M, Koperski S, Koslik HJ, Devaraj S, Ritchie JB. Coenzyme Q10 benefits symptoms in Gulf War veterans: results of a randomized double-blind study. Neural Comput. 2014;26(11):2594-2651.
19. Weiduschat N, Mao X, Vu D, et al. N-acetylcysteine alleviates cortical glutathione deficit and improves symptoms in CFS: an in vivo validation study using proton magnetic resonance spectroscopy. In: Proceedings from the IACFS/ME 12th Biennial Conference; October 27-30, 2016; Fort Lauderdale, FL. Abstract. http://iacfsme.org/ME-CFS-Primer-Education/News/IACFSME-2016-Program.aspx. Accessed April 22, 2019.
20. White RF, Steele L, O’Callaghan JP, et al. Recent research on Gulf War illness and other health problems in veterans of the 1991 Gulf War: effects of toxicant exposures during deployment. Cortex. 2016;74:449-475.
21. US Department of Veterans Affairs. Caring for Gulf War I Veterans. http://www.ngwrc.net/PDF%20Files/caring-for-gulf-war.pdf. Published July 2011. Accessed April 15, 2019.
22. National Academies of Sciences, Engineering, and Medicine. Gulf War and Health. Update of Serving in the Gulf War. Vol 10. Washington, DC: National Academies Press; 2016.
23. US Department of Veterans Affairs. War-Related Illness and Injury Study Center. Gulf War illness: a guide for veteran health care providers. https://www.warrelatedillness.va.gov/education/factsheets/gulf-war-illness-for-providers.pdf. Updated October 2018. Accessed April 16, 2019.
1. US Department of Veterans Affairs. Research Advisory Committee on Gulf War Veterans’ Illnesses. Gulf War Illness and the Health of Gulf War Veterans: Scientific Findings and Recommendations. https://www.va.gov/RAC-GWVI/docs/Committee_Documents/GWIandHealthofGWVeterans_RAC-GWVIReport_2008.pdf. Published November 2008. Accessed April 16, 2019.
2. Institute of Medicine. Gulf War and Health. Update of Health Effects of Serving in the Gulf War. Vol 8. Washington, DC: National Academies Press; 2009.
3. Fukuda K, Nisenbaum R, Stewart G, et al. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998;280(11):981-988.
4. Steele L. Prevalence and patterns of Gulf War illness in Kansas veterans: association of symptoms with characteristics of person, place, and time of military service. Am J Epidemiol. 2000;152(10):992-1002.
5. Kang HK, Mahan CM, Lee KY, Magee CA, Murphy FM. Illnesses among United States veterans of the Gulf War: a population-based survey of 30,000 veterans. J Occup Environ Med. 2000;42(5):491-501.
6. Kang HK, Li B, Mahan CM, Eisen SA, Engel CC. Health of US veterans of 1991 Gulf War: a follow-up survey in 10 years. J Occup Environ Med. 2009;51(4):401-410.
7. Dursa EK, Barth SK, Schneiderman AI, Bossarte RM. Physical and mental health status of Gulf War and Gulf era veterans: results from a large population-based epidemiological study. J Occup Environ Med. 2016;58(1):41-46.
8. Institute of Medicine. Gulf War and Health: Treatment for Chronic Multisymptom Illness. Washington, DC: National Academies Press; 2013.
9. Institute of Medicine. Chronic Multisymptom Illness in Gulf War Veterans: Case Definitions Reexamined. Washington, DC: National Academies Press; 2014.
10. United States Government Accountability Office. Gulf War illness: improvements needed for VA to better understand, process, and communicate decisions on claims. https://www.gao.gov/assets/690/685562.pdf. Published June 2017. Accessed April 16, 2019.
11. Johnson GJ, Slater BC, Leis LA, Rector TS, Bach RR. Blood biomarkers of chronic inflammation in Gulf War illness. PLoS One. 2016;11(6):e0157855.
12. Reno J. Gulf War veterans still fighting serious health problems. https://www.healthline.com/health-news/gulf-war-veterans-still-fighting-serious-health-problems#1. Published June 17, 2016. Accessed April 16, 2019.
13. McAndrew LM, Helmer DA, Phillips LA, Chandler HK, Ray K, Quigley KS. Iraq and Afghanistan veterans report symptoms consistent with chronic multisymptom illness one year after deployment. J Rehabil Res Dev. 2016;53(1):59-70.
14. Steele L, Sastre A, Gerkovich MM, Cook MR. Complex factors in the etiology of Gulf War illness: wartime exposures and risk factors in veteran subgroups. Environ Health Perspect. 2012;120(1):112-118.
15. US Department of Veterans Affairs. VA/DoD Clinical Practice Guideline for the Management of Chronic Multisymptom Illness. Version 2.0. https://www.healthquality.va.gov/guidelines/MR/cmi/VADoDCMICPG2014.pdf. Published October 2014. Accessed April 22, 2019.
16. Koslik HJ, Hamilton G, Golomb BA. Mitochondrial dysfunction in Gulf War illness revealed by 31phosphorus magnetic resonance spectroscopy: a case-control study. PLoS One. 2014;9(3):e92887.
17. Brewer KL, Mainhart A, Meggs WJ. Double-blinded placebo-controlled cross-over pilot trial of naltrexone to treat Gulf War illness. Fatigue: Biomed Health Behav. 2018;6(3):132-140.
18. Golomb BA, Allison M, Koperski S, Koslik HJ, Devaraj S, Ritchie JB. Coenzyme Q10 benefits symptoms in Gulf War veterans: results of a randomized double-blind study. Neural Comput. 2014;26(11):2594-2651.
19. Weiduschat N, Mao X, Vu D, et al. N-acetylcysteine alleviates cortical glutathione deficit and improves symptoms in CFS: an in vivo validation study using proton magnetic resonance spectroscopy. In: Proceedings from the IACFS/ME 12th Biennial Conference; October 27-30, 2016; Fort Lauderdale, FL. Abstract. http://iacfsme.org/ME-CFS-Primer-Education/News/IACFSME-2016-Program.aspx. Accessed April 22, 2019.
20. White RF, Steele L, O’Callaghan JP, et al. Recent research on Gulf War illness and other health problems in veterans of the 1991 Gulf War: effects of toxicant exposures during deployment. Cortex. 2016;74:449-475.
21. US Department of Veterans Affairs. Caring for Gulf War I Veterans. http://www.ngwrc.net/PDF%20Files/caring-for-gulf-war.pdf. Published July 2011. Accessed April 15, 2019.
22. National Academies of Sciences, Engineering, and Medicine. Gulf War and Health. Update of Serving in the Gulf War. Vol 10. Washington, DC: National Academies Press; 2016.
23. US Department of Veterans Affairs. War-Related Illness and Injury Study Center. Gulf War illness: a guide for veteran health care providers. https://www.warrelatedillness.va.gov/education/factsheets/gulf-war-illness-for-providers.pdf. Updated October 2018. Accessed April 16, 2019.
Electronic health records linked to lower patient safety
Higher reliance on electronic health records (EHRs) in ambulatory oncology practice was significantly associated with reduced safety actions among oncology nurses and prescribers, according to results of a statewide survey.
“The purpose of this study was to investigate the degree to which EHRs, satisfaction with technology, and clinician communication enable a safety culture in ambulatory oncology treatment settings,” wrote Minal R. Patel, PhD, MPH, of the University of Michigan, Ann Arbor, and colleagues. The report is published in the Journal of Oncology Practice.
The researchers conducted a statewide survey of 297 oncology nurses and prescribers in 29 ambulatory oncology practices in Michigan. They obtained quantitative data for May to October 2017 from clinician surveys and practice logs at these clinical sites.
The study methodology was built by use of the sociotechnical framework, which examined how EHR technologies influenced the safe administration of chemotherapy.
Eligible survey participants included physicians, nurses, physician assistants, and nurse practitioners who cared for adult patients receiving infusion treatments for cancer.
A total of 438 clinicians were recruited and confirmed to be eligible, and 297 (68%) completed a survey.
After analysis, the researchers found that higher reliance on electronic health records in practice was associated with reduced safety scores (P less than .001). The mean safety score was reported to be 5.3 (standard deviation, 1.1; practice-level range, 4.9-5.4).
In an opposite manner, increased satisfaction with technology and better-quality communication were associated with higher safety actions.
The researchers acknowledged a key limitation of the study was cross-sectional design. As a result, confounding factors could influence the findings.
“Careful attention to technology adoption and updates coupled with high-quality communication skills across clinicians are promising strategies to administer high-risk treatments safely in ambulatory oncology settings,” they concluded.
The study was supported by grant funding from the Agency for Healthcare Research and Quality and the National Cancer Institute. No conflicts of interest were reported.
SOURCE: Patel MR et al. J Oncol Pract. 2019 Apr 22. doi: 10.1200/JOP.18.00507.
Higher reliance on electronic health records (EHRs) in ambulatory oncology practice was significantly associated with reduced safety actions among oncology nurses and prescribers, according to results of a statewide survey.
“The purpose of this study was to investigate the degree to which EHRs, satisfaction with technology, and clinician communication enable a safety culture in ambulatory oncology treatment settings,” wrote Minal R. Patel, PhD, MPH, of the University of Michigan, Ann Arbor, and colleagues. The report is published in the Journal of Oncology Practice.
The researchers conducted a statewide survey of 297 oncology nurses and prescribers in 29 ambulatory oncology practices in Michigan. They obtained quantitative data for May to October 2017 from clinician surveys and practice logs at these clinical sites.
The study methodology was built by use of the sociotechnical framework, which examined how EHR technologies influenced the safe administration of chemotherapy.
Eligible survey participants included physicians, nurses, physician assistants, and nurse practitioners who cared for adult patients receiving infusion treatments for cancer.
A total of 438 clinicians were recruited and confirmed to be eligible, and 297 (68%) completed a survey.
After analysis, the researchers found that higher reliance on electronic health records in practice was associated with reduced safety scores (P less than .001). The mean safety score was reported to be 5.3 (standard deviation, 1.1; practice-level range, 4.9-5.4).
In an opposite manner, increased satisfaction with technology and better-quality communication were associated with higher safety actions.
The researchers acknowledged a key limitation of the study was cross-sectional design. As a result, confounding factors could influence the findings.
“Careful attention to technology adoption and updates coupled with high-quality communication skills across clinicians are promising strategies to administer high-risk treatments safely in ambulatory oncology settings,” they concluded.
The study was supported by grant funding from the Agency for Healthcare Research and Quality and the National Cancer Institute. No conflicts of interest were reported.
SOURCE: Patel MR et al. J Oncol Pract. 2019 Apr 22. doi: 10.1200/JOP.18.00507.
Higher reliance on electronic health records (EHRs) in ambulatory oncology practice was significantly associated with reduced safety actions among oncology nurses and prescribers, according to results of a statewide survey.
“The purpose of this study was to investigate the degree to which EHRs, satisfaction with technology, and clinician communication enable a safety culture in ambulatory oncology treatment settings,” wrote Minal R. Patel, PhD, MPH, of the University of Michigan, Ann Arbor, and colleagues. The report is published in the Journal of Oncology Practice.
The researchers conducted a statewide survey of 297 oncology nurses and prescribers in 29 ambulatory oncology practices in Michigan. They obtained quantitative data for May to October 2017 from clinician surveys and practice logs at these clinical sites.
The study methodology was built by use of the sociotechnical framework, which examined how EHR technologies influenced the safe administration of chemotherapy.
Eligible survey participants included physicians, nurses, physician assistants, and nurse practitioners who cared for adult patients receiving infusion treatments for cancer.
A total of 438 clinicians were recruited and confirmed to be eligible, and 297 (68%) completed a survey.
After analysis, the researchers found that higher reliance on electronic health records in practice was associated with reduced safety scores (P less than .001). The mean safety score was reported to be 5.3 (standard deviation, 1.1; practice-level range, 4.9-5.4).
In an opposite manner, increased satisfaction with technology and better-quality communication were associated with higher safety actions.
The researchers acknowledged a key limitation of the study was cross-sectional design. As a result, confounding factors could influence the findings.
“Careful attention to technology adoption and updates coupled with high-quality communication skills across clinicians are promising strategies to administer high-risk treatments safely in ambulatory oncology settings,” they concluded.
The study was supported by grant funding from the Agency for Healthcare Research and Quality and the National Cancer Institute. No conflicts of interest were reported.
SOURCE: Patel MR et al. J Oncol Pract. 2019 Apr 22. doi: 10.1200/JOP.18.00507.
FROM JOURNAL OF ONCOLOGY PRACTICE
FDA chief calls for release of all data tracking problems with medical devices
Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to
“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.
A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.
Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.
Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”
The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.
Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.
“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”
Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.
As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.
Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”
“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to
“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.
A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.
Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.
Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”
The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.
Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.
“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”
Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.
As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.
Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”
“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to
“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.
A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.
Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.
Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”
The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.
Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.
“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”
Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.
As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.
Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”
“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
VA Community Living Centers Health Care Reports Are Now Public
Although VA nursing homes, on the whole, have sicker patients than do those in private sector nursing homes, they compare closely in terms of quality of care—and in some cases, VA health care gets higher marks. VA has more higher performing facilities (17% vs 11%) and fewer low-performing facilities (17% vs 20%).
Those figures come from the health care inspection reports and staffing data for its 134 community living centers (CLCs) that the VA is, for the first time, posting publicly. So far, VA has posted 101 health inspection reports; the remainder are scheduled for later this year. The reports cover April 2018 to the present.
The VA reports are based on yearly, unannounced inspections conducted by an outside contracted agency. The survey teams assess a variety of aspects of life at VA nursing homes, such as the care of residents and the processes used to give that care, how the staff and residents interact, and the nursing home environment. The surveyors also review residents’ clinical records and interview residents, family members, caregivers, and staff.
VA nursing homes also had a significantly lower percentage (6%) of 1-star (lowest rated) nursing homes compared with 15,487 private sector nursing homes rated by the Centers for Medicare and Medicaid Services. Both Medicare-certified skilled nursing facilities and VA CLCs must meet federal standards, such as having enough staff to provide adequate care. “There is significant evidence of a relationship between resident outcomes and staffing levels in nursing homes,” the VA says in its description of survey criteria.
Many VA nursing home residents are being treated for conditions rarely seen in private sector nursing homes, the VA says, including veteran-specific conditions, such as posttraumatic stress disorder (12% vs 0.5%) and traumatic brain injury (2% vs 0.8%). In 2018, 42% of 41,076 VA CLC residents had a service-connected disability rating of ≥ 50%. CLCs also provide more hospice care and care for conditions related to homelessness.
However, the VA notes that “quality measures are not the same as quality standards.” According to Medicare Nursing Home Compare, the quality of resident care measures are not benchmarks, thresholds, guidelines, or standards of care—they are a “snapshot at a point in time” of the average condition of residents. For instance, individual CLCs may serve special populations and have a higher rate of certain conditions. A CLC that specializes in complex skin and wound care may admit veterans with severe pressure ulcers that occurred at home or another hospital.
Detailed information on individual quality measures and how VA facilities compare with others in their areas are available at www.accesstocare.va.gov/healthcare/qualityofcare. That site also has an interactive searchable map that can be used to locate CLCs by zip code or distance. The health inspection reports are available at www.va.gov/qualityofcare/apps/aspire/clcsurvey.aspx.
Although VA nursing homes, on the whole, have sicker patients than do those in private sector nursing homes, they compare closely in terms of quality of care—and in some cases, VA health care gets higher marks. VA has more higher performing facilities (17% vs 11%) and fewer low-performing facilities (17% vs 20%).
Those figures come from the health care inspection reports and staffing data for its 134 community living centers (CLCs) that the VA is, for the first time, posting publicly. So far, VA has posted 101 health inspection reports; the remainder are scheduled for later this year. The reports cover April 2018 to the present.
The VA reports are based on yearly, unannounced inspections conducted by an outside contracted agency. The survey teams assess a variety of aspects of life at VA nursing homes, such as the care of residents and the processes used to give that care, how the staff and residents interact, and the nursing home environment. The surveyors also review residents’ clinical records and interview residents, family members, caregivers, and staff.
VA nursing homes also had a significantly lower percentage (6%) of 1-star (lowest rated) nursing homes compared with 15,487 private sector nursing homes rated by the Centers for Medicare and Medicaid Services. Both Medicare-certified skilled nursing facilities and VA CLCs must meet federal standards, such as having enough staff to provide adequate care. “There is significant evidence of a relationship between resident outcomes and staffing levels in nursing homes,” the VA says in its description of survey criteria.
Many VA nursing home residents are being treated for conditions rarely seen in private sector nursing homes, the VA says, including veteran-specific conditions, such as posttraumatic stress disorder (12% vs 0.5%) and traumatic brain injury (2% vs 0.8%). In 2018, 42% of 41,076 VA CLC residents had a service-connected disability rating of ≥ 50%. CLCs also provide more hospice care and care for conditions related to homelessness.
However, the VA notes that “quality measures are not the same as quality standards.” According to Medicare Nursing Home Compare, the quality of resident care measures are not benchmarks, thresholds, guidelines, or standards of care—they are a “snapshot at a point in time” of the average condition of residents. For instance, individual CLCs may serve special populations and have a higher rate of certain conditions. A CLC that specializes in complex skin and wound care may admit veterans with severe pressure ulcers that occurred at home or another hospital.
Detailed information on individual quality measures and how VA facilities compare with others in their areas are available at www.accesstocare.va.gov/healthcare/qualityofcare. That site also has an interactive searchable map that can be used to locate CLCs by zip code or distance. The health inspection reports are available at www.va.gov/qualityofcare/apps/aspire/clcsurvey.aspx.
Although VA nursing homes, on the whole, have sicker patients than do those in private sector nursing homes, they compare closely in terms of quality of care—and in some cases, VA health care gets higher marks. VA has more higher performing facilities (17% vs 11%) and fewer low-performing facilities (17% vs 20%).
Those figures come from the health care inspection reports and staffing data for its 134 community living centers (CLCs) that the VA is, for the first time, posting publicly. So far, VA has posted 101 health inspection reports; the remainder are scheduled for later this year. The reports cover April 2018 to the present.
The VA reports are based on yearly, unannounced inspections conducted by an outside contracted agency. The survey teams assess a variety of aspects of life at VA nursing homes, such as the care of residents and the processes used to give that care, how the staff and residents interact, and the nursing home environment. The surveyors also review residents’ clinical records and interview residents, family members, caregivers, and staff.
VA nursing homes also had a significantly lower percentage (6%) of 1-star (lowest rated) nursing homes compared with 15,487 private sector nursing homes rated by the Centers for Medicare and Medicaid Services. Both Medicare-certified skilled nursing facilities and VA CLCs must meet federal standards, such as having enough staff to provide adequate care. “There is significant evidence of a relationship between resident outcomes and staffing levels in nursing homes,” the VA says in its description of survey criteria.
Many VA nursing home residents are being treated for conditions rarely seen in private sector nursing homes, the VA says, including veteran-specific conditions, such as posttraumatic stress disorder (12% vs 0.5%) and traumatic brain injury (2% vs 0.8%). In 2018, 42% of 41,076 VA CLC residents had a service-connected disability rating of ≥ 50%. CLCs also provide more hospice care and care for conditions related to homelessness.
However, the VA notes that “quality measures are not the same as quality standards.” According to Medicare Nursing Home Compare, the quality of resident care measures are not benchmarks, thresholds, guidelines, or standards of care—they are a “snapshot at a point in time” of the average condition of residents. For instance, individual CLCs may serve special populations and have a higher rate of certain conditions. A CLC that specializes in complex skin and wound care may admit veterans with severe pressure ulcers that occurred at home or another hospital.
Detailed information on individual quality measures and how VA facilities compare with others in their areas are available at www.accesstocare.va.gov/healthcare/qualityofcare. That site also has an interactive searchable map that can be used to locate CLCs by zip code or distance. The health inspection reports are available at www.va.gov/qualityofcare/apps/aspire/clcsurvey.aspx.
AAP, AHA push for policies limiting children’s sugary beverage consumption
Physicians should actively advocate for policies that will reduce children’s consumption of sugar-sweetened beverages and subsequently reduce their risk of obesity, type 2 diabetes and other chronic diseases, urges a new policy statement from the American Academy of Pediatrics and the American Heart Association.
As “the leading source of added sugars in the U.S. diet,” sugary drinks “provide little to no nutritional value, are high in energy density, and do little to increase feelings of satiety,” wrote Natalie D. Muth, MD, MPH, of the University of California, Los Angeles, and the Children’s Primary Care Medical Group in Carlsbad, Calif., and her associates from the AAP’s Section on Obesity, the AAP’s Committee on Nutrition, and the American Heart Association.
Added sugars include sucrose, glucose, high-fructose corn syrup and processed fruit juice (but not naturally occurring fructose or lactose) that are added as sweeteners to food and drink products. In addition to contributing to childhood obesity, consuming drinks with added sugars increases children’s risk for “dental decay, cardiovascular disease, hypertension, dyslipidemia, insulin resistance, type 2 diabetes mellitus, fatty liver disease and all-cause mortality,” the statement noted.
Although less than 10% of individuals’ total calories should come from added sugars, according to the 2015–2020 Dietary Guidelines for Americans, added sugars make up an estimated 17% of U.S. children’s and teens’ average total caloric intake, and sugary drinks comprise almost half of this excess sugar, the statement noted. Consumption is higher and therefore more harmful in several subgroups, particularly those from minority and economically disadvantaged communities.
Previous AAP policy statements have urged doctors to encourage children and teens to drink water instead of high-calorie drinks, such as fruit juice, energy drinks and high-carbohydrate “sports drinks.” But this statement takes a page from success with tobacco control measures and focuses on the need for policy changes at local, state, and federal levels to help to reduce children’s intake of sugary drinks.
The statement makes six major recommendations:
• Excise tax: The AAP and AHA support the use of excise taxes or other means of increasing the cost of sugar-sweetened beverages – alongside an educational campaign to explain the rationale – and apportioning some of the subsequent revenue to addressing health and socioeconomic disparities.
Evidence shows how tobacco and alcohol consumption declined as their prices rose from taxes, and several places that have already implemented a sugary beverage tax have seen similar declines in consumption. Research models suggest an excise tax would potentially prevent 575,000 cases of childhood obesity.
• Reducing advertising/marketing: Research shows that teens, especially low-income and minority teens, are exposed to high amounts of advertising for soft drinks, fruit drinks, energy drinks, and sports drinks. Though such advertising cannot be outright banned without violating free speech, policies can disincentivize such marketing, such as “eliminating the advertising subsidy for nutritionally poor foods and beverages marketed to children” and not allowing in-school marketing.
• Improve existing nutritional assistance programs: WIC, the Child and Adult Care Food Program, school breakfast and lunch programs, and the Supplemental Nutrition Assistance Program (SNAP) vary in how well they discourage sugary drink consumption and can be improved through legislative changes.
• Consumer risk information: The AAP and AHA promote use of clear nutrition labels and menu labeling that explain the sugar content and risks of products, “including warning labels of the health harms of consumption of added sugars” not unlike those on cigarette packages.
• Changing the default: Physicians should advocate for policies that reduce access to sugary drinks and prioritize access to water and similarly healthier options.
• Norm-changing medical industry: Hospitals should implement policies that reduce consumption and/or access to sugary beverages, such as higher prices, less availability and risk-related labeling.
Pediatricians should continue to advise families about the risks of consuming added sugars, the substantial contribution that sugary drinks make to excess sugars in one’s diet, and the need to replace sugar-sweetened beverages with drinking water. Yet pediatricians can go beyond individual recommendations by advocating “for policy change through school boards, school health councils, hospital and medical group boards and committees, outreach to elected representatives and public comment opportunities.”
The statement used no external funding, and the authors had no disclosures or conflicts of interest.
SOURCE: Muth ND et al. Pediatrics. 2019;143(4):e20190282. doi: 10.1542/peds.2019-0282
Make counseling on healthy eating and exercise a priority
Pediatricians daily bear witness to the impact of poor nutrition on the health and quality of life of children. Healthy eating and drinking has long been an expected domain of conversation with children, adolescents and their families. In recent years, counseling regarding the consumption of added sugars, especially those in sugar-sweetened beverages (SSB), has gained traction. Pediatricians are aware of the health risks associated with over-consumption of SSB and that these risks, and consumption of sugary drinks, are more prevalent among the most vulnerable of children, including minorities and those living in low-income communities.
Primary care pediatricians face many demands that compete for time and attention, and time spent counseling on healthy eating and exercise needs to continue to be a priority. AAP-supported initiatives, such as the 5-3-2-1-0 rule – five vegetables and fruits per day, three structured meals, 2 hours or less of screen time, 1 hour or more of physical activity and zero sugary drinks most days – provide simple, clear messaging about limiting of sugary drinks. We should promote drinking of water as first choice, including during sports activities.
Messaging with community partners and on social media maximizes the impact of these important messages. The new AAP guideline “Public Policies to Reduce Sugary Drink Consumption in Children and Adolescents” also advocates for decreasing sugary drink marketing to children and adolescents. Pediatricians are trusted, credible voices who are well-positioned to advocate for an ad-free childhood, including SSB ads.
Melinda Clark, MD, is an associate professor of pediatrics at the Albany (N.Y.) Medical Center, and a MDedge Pediatrics editorial advisory board member. Dr. Clark had no disclosures.
Make counseling on healthy eating and exercise a priority
Pediatricians daily bear witness to the impact of poor nutrition on the health and quality of life of children. Healthy eating and drinking has long been an expected domain of conversation with children, adolescents and their families. In recent years, counseling regarding the consumption of added sugars, especially those in sugar-sweetened beverages (SSB), has gained traction. Pediatricians are aware of the health risks associated with over-consumption of SSB and that these risks, and consumption of sugary drinks, are more prevalent among the most vulnerable of children, including minorities and those living in low-income communities.
Primary care pediatricians face many demands that compete for time and attention, and time spent counseling on healthy eating and exercise needs to continue to be a priority. AAP-supported initiatives, such as the 5-3-2-1-0 rule – five vegetables and fruits per day, three structured meals, 2 hours or less of screen time, 1 hour or more of physical activity and zero sugary drinks most days – provide simple, clear messaging about limiting of sugary drinks. We should promote drinking of water as first choice, including during sports activities.
Messaging with community partners and on social media maximizes the impact of these important messages. The new AAP guideline “Public Policies to Reduce Sugary Drink Consumption in Children and Adolescents” also advocates for decreasing sugary drink marketing to children and adolescents. Pediatricians are trusted, credible voices who are well-positioned to advocate for an ad-free childhood, including SSB ads.
Melinda Clark, MD, is an associate professor of pediatrics at the Albany (N.Y.) Medical Center, and a MDedge Pediatrics editorial advisory board member. Dr. Clark had no disclosures.
Make counseling on healthy eating and exercise a priority
Pediatricians daily bear witness to the impact of poor nutrition on the health and quality of life of children. Healthy eating and drinking has long been an expected domain of conversation with children, adolescents and their families. In recent years, counseling regarding the consumption of added sugars, especially those in sugar-sweetened beverages (SSB), has gained traction. Pediatricians are aware of the health risks associated with over-consumption of SSB and that these risks, and consumption of sugary drinks, are more prevalent among the most vulnerable of children, including minorities and those living in low-income communities.
Primary care pediatricians face many demands that compete for time and attention, and time spent counseling on healthy eating and exercise needs to continue to be a priority. AAP-supported initiatives, such as the 5-3-2-1-0 rule – five vegetables and fruits per day, three structured meals, 2 hours or less of screen time, 1 hour or more of physical activity and zero sugary drinks most days – provide simple, clear messaging about limiting of sugary drinks. We should promote drinking of water as first choice, including during sports activities.
Messaging with community partners and on social media maximizes the impact of these important messages. The new AAP guideline “Public Policies to Reduce Sugary Drink Consumption in Children and Adolescents” also advocates for decreasing sugary drink marketing to children and adolescents. Pediatricians are trusted, credible voices who are well-positioned to advocate for an ad-free childhood, including SSB ads.
Melinda Clark, MD, is an associate professor of pediatrics at the Albany (N.Y.) Medical Center, and a MDedge Pediatrics editorial advisory board member. Dr. Clark had no disclosures.
Physicians should actively advocate for policies that will reduce children’s consumption of sugar-sweetened beverages and subsequently reduce their risk of obesity, type 2 diabetes and other chronic diseases, urges a new policy statement from the American Academy of Pediatrics and the American Heart Association.
As “the leading source of added sugars in the U.S. diet,” sugary drinks “provide little to no nutritional value, are high in energy density, and do little to increase feelings of satiety,” wrote Natalie D. Muth, MD, MPH, of the University of California, Los Angeles, and the Children’s Primary Care Medical Group in Carlsbad, Calif., and her associates from the AAP’s Section on Obesity, the AAP’s Committee on Nutrition, and the American Heart Association.
Added sugars include sucrose, glucose, high-fructose corn syrup and processed fruit juice (but not naturally occurring fructose or lactose) that are added as sweeteners to food and drink products. In addition to contributing to childhood obesity, consuming drinks with added sugars increases children’s risk for “dental decay, cardiovascular disease, hypertension, dyslipidemia, insulin resistance, type 2 diabetes mellitus, fatty liver disease and all-cause mortality,” the statement noted.
Although less than 10% of individuals’ total calories should come from added sugars, according to the 2015–2020 Dietary Guidelines for Americans, added sugars make up an estimated 17% of U.S. children’s and teens’ average total caloric intake, and sugary drinks comprise almost half of this excess sugar, the statement noted. Consumption is higher and therefore more harmful in several subgroups, particularly those from minority and economically disadvantaged communities.
Previous AAP policy statements have urged doctors to encourage children and teens to drink water instead of high-calorie drinks, such as fruit juice, energy drinks and high-carbohydrate “sports drinks.” But this statement takes a page from success with tobacco control measures and focuses on the need for policy changes at local, state, and federal levels to help to reduce children’s intake of sugary drinks.
The statement makes six major recommendations:
• Excise tax: The AAP and AHA support the use of excise taxes or other means of increasing the cost of sugar-sweetened beverages – alongside an educational campaign to explain the rationale – and apportioning some of the subsequent revenue to addressing health and socioeconomic disparities.
Evidence shows how tobacco and alcohol consumption declined as their prices rose from taxes, and several places that have already implemented a sugary beverage tax have seen similar declines in consumption. Research models suggest an excise tax would potentially prevent 575,000 cases of childhood obesity.
• Reducing advertising/marketing: Research shows that teens, especially low-income and minority teens, are exposed to high amounts of advertising for soft drinks, fruit drinks, energy drinks, and sports drinks. Though such advertising cannot be outright banned without violating free speech, policies can disincentivize such marketing, such as “eliminating the advertising subsidy for nutritionally poor foods and beverages marketed to children” and not allowing in-school marketing.
• Improve existing nutritional assistance programs: WIC, the Child and Adult Care Food Program, school breakfast and lunch programs, and the Supplemental Nutrition Assistance Program (SNAP) vary in how well they discourage sugary drink consumption and can be improved through legislative changes.
• Consumer risk information: The AAP and AHA promote use of clear nutrition labels and menu labeling that explain the sugar content and risks of products, “including warning labels of the health harms of consumption of added sugars” not unlike those on cigarette packages.
• Changing the default: Physicians should advocate for policies that reduce access to sugary drinks and prioritize access to water and similarly healthier options.
• Norm-changing medical industry: Hospitals should implement policies that reduce consumption and/or access to sugary beverages, such as higher prices, less availability and risk-related labeling.
Pediatricians should continue to advise families about the risks of consuming added sugars, the substantial contribution that sugary drinks make to excess sugars in one’s diet, and the need to replace sugar-sweetened beverages with drinking water. Yet pediatricians can go beyond individual recommendations by advocating “for policy change through school boards, school health councils, hospital and medical group boards and committees, outreach to elected representatives and public comment opportunities.”
The statement used no external funding, and the authors had no disclosures or conflicts of interest.
SOURCE: Muth ND et al. Pediatrics. 2019;143(4):e20190282. doi: 10.1542/peds.2019-0282
Physicians should actively advocate for policies that will reduce children’s consumption of sugar-sweetened beverages and subsequently reduce their risk of obesity, type 2 diabetes and other chronic diseases, urges a new policy statement from the American Academy of Pediatrics and the American Heart Association.
As “the leading source of added sugars in the U.S. diet,” sugary drinks “provide little to no nutritional value, are high in energy density, and do little to increase feelings of satiety,” wrote Natalie D. Muth, MD, MPH, of the University of California, Los Angeles, and the Children’s Primary Care Medical Group in Carlsbad, Calif., and her associates from the AAP’s Section on Obesity, the AAP’s Committee on Nutrition, and the American Heart Association.
Added sugars include sucrose, glucose, high-fructose corn syrup and processed fruit juice (but not naturally occurring fructose or lactose) that are added as sweeteners to food and drink products. In addition to contributing to childhood obesity, consuming drinks with added sugars increases children’s risk for “dental decay, cardiovascular disease, hypertension, dyslipidemia, insulin resistance, type 2 diabetes mellitus, fatty liver disease and all-cause mortality,” the statement noted.
Although less than 10% of individuals’ total calories should come from added sugars, according to the 2015–2020 Dietary Guidelines for Americans, added sugars make up an estimated 17% of U.S. children’s and teens’ average total caloric intake, and sugary drinks comprise almost half of this excess sugar, the statement noted. Consumption is higher and therefore more harmful in several subgroups, particularly those from minority and economically disadvantaged communities.
Previous AAP policy statements have urged doctors to encourage children and teens to drink water instead of high-calorie drinks, such as fruit juice, energy drinks and high-carbohydrate “sports drinks.” But this statement takes a page from success with tobacco control measures and focuses on the need for policy changes at local, state, and federal levels to help to reduce children’s intake of sugary drinks.
The statement makes six major recommendations:
• Excise tax: The AAP and AHA support the use of excise taxes or other means of increasing the cost of sugar-sweetened beverages – alongside an educational campaign to explain the rationale – and apportioning some of the subsequent revenue to addressing health and socioeconomic disparities.
Evidence shows how tobacco and alcohol consumption declined as their prices rose from taxes, and several places that have already implemented a sugary beverage tax have seen similar declines in consumption. Research models suggest an excise tax would potentially prevent 575,000 cases of childhood obesity.
• Reducing advertising/marketing: Research shows that teens, especially low-income and minority teens, are exposed to high amounts of advertising for soft drinks, fruit drinks, energy drinks, and sports drinks. Though such advertising cannot be outright banned without violating free speech, policies can disincentivize such marketing, such as “eliminating the advertising subsidy for nutritionally poor foods and beverages marketed to children” and not allowing in-school marketing.
• Improve existing nutritional assistance programs: WIC, the Child and Adult Care Food Program, school breakfast and lunch programs, and the Supplemental Nutrition Assistance Program (SNAP) vary in how well they discourage sugary drink consumption and can be improved through legislative changes.
• Consumer risk information: The AAP and AHA promote use of clear nutrition labels and menu labeling that explain the sugar content and risks of products, “including warning labels of the health harms of consumption of added sugars” not unlike those on cigarette packages.
• Changing the default: Physicians should advocate for policies that reduce access to sugary drinks and prioritize access to water and similarly healthier options.
• Norm-changing medical industry: Hospitals should implement policies that reduce consumption and/or access to sugary beverages, such as higher prices, less availability and risk-related labeling.
Pediatricians should continue to advise families about the risks of consuming added sugars, the substantial contribution that sugary drinks make to excess sugars in one’s diet, and the need to replace sugar-sweetened beverages with drinking water. Yet pediatricians can go beyond individual recommendations by advocating “for policy change through school boards, school health councils, hospital and medical group boards and committees, outreach to elected representatives and public comment opportunities.”
The statement used no external funding, and the authors had no disclosures or conflicts of interest.
SOURCE: Muth ND et al. Pediatrics. 2019;143(4):e20190282. doi: 10.1542/peds.2019-0282
FROM PEDIATRICS
FDA chief calls for stricter scrutiny of electronic health records
“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Dr. Gottlieb said in an interview with Kaiser Health News.
Dr. Gottlieb was responding to “Botched Operation,” a report published March 18 by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries, and near misses linked to EHRs have piled up in databases – including at least one run by the FDA.
Dr. Gottlieb said Congress would need to enact legislation to define when an EHR would require government oversight. He said that the digital records systems, which store a patient’s medical history, don’t fit neatly under the agency’s existing mandate to regulate items such as drugs and medical devices.
Dr. Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren’t the same as for a traditional medical device implanted in a patient. “You need a much different regulatory scheme,” he said.
The 21st Century Cures Act of 2016 excludes the FDA from having oversight over EHRs as a medical device.
Dr. Gottlieb said that health IT companies could add new functions that would improve EHRs, but they have been reluctant to do so because they didn’t want their products to fall under FDA jurisdiction. He added that he was “not calling” for FDA to take over such a duty, however, and suggested that any new approach could be years away. Proponents have long argued that widespread use of EHRs can make medicine safer by alerting doctors to potential medical errors, though critics counter that software glitches and user errors may cause new varieties of medical mistakes.
How closely the FDA should watch over the digital medical record revolution has been controversial for years. The agency’s interest in the issue perked up after Congress decided in February 2009 to spend billions of dollars on digital medical records as part of an economic stimulus program.
At the time, many industry groups argued that FDA regulation would “stifle innovation” and stall the national drive to bring medicine into the modern era. Federal officials responsible for doling out billions in subsidies to doctors and hospitals generally sympathized with that view and were skeptical of allowing the FDA to play a role.
The debate became public in February 2010, when Jeffrey Shuren, MD, an FDA official, testified at a public hearing that the agency had tied 6 deaths and more than 200 injuries to health information technology. In all, the FDA said, it had logged 260 reports in the previous 2 years of “malfunctions with the potential for patient harm.”
The agency said the findings were based largely on reports voluntarily submitted to the FDA and suggested “significant clinical implications and public safety issues.” In one case cited, lab tests done in a hospital emergency department were sent to the wrong patient’s file. Since then, several government and private repositories have associated thousands of injuries, near misses, and deaths to EHR technology.
Dr. Shuren said in 2010 that the agency recognized that health information technology had great potential to improve patient care, but also needed oversight to “assure patient safety.”
While some safety proponents agree that EHRs offer tremendous benefits, they also see a greater opportunities to improve their safety.
Dean Sittig, PhD, a professor of bioinformatics and bioengineering at the University of Texas, Houston, said EHRs have improved safety within the health care system, but they have not eliminated errors to the extent that he would have expected. Federal officials were initially pushing for rapid adoption and ‘there wasn’t a lot of interest in talking about things that could go wrong,’ ” Dr. Sittig told KHN and Fortune.
Earlier in March, Gottlieb announced his resignation from the FDA. His last day is scheduled to be April 5.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN correspondents Sarah Jane Tribble, Sydney Lupkin, and Julie Rovner contributed to this report.
“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Dr. Gottlieb said in an interview with Kaiser Health News.
Dr. Gottlieb was responding to “Botched Operation,” a report published March 18 by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries, and near misses linked to EHRs have piled up in databases – including at least one run by the FDA.
Dr. Gottlieb said Congress would need to enact legislation to define when an EHR would require government oversight. He said that the digital records systems, which store a patient’s medical history, don’t fit neatly under the agency’s existing mandate to regulate items such as drugs and medical devices.
Dr. Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren’t the same as for a traditional medical device implanted in a patient. “You need a much different regulatory scheme,” he said.
The 21st Century Cures Act of 2016 excludes the FDA from having oversight over EHRs as a medical device.
Dr. Gottlieb said that health IT companies could add new functions that would improve EHRs, but they have been reluctant to do so because they didn’t want their products to fall under FDA jurisdiction. He added that he was “not calling” for FDA to take over such a duty, however, and suggested that any new approach could be years away. Proponents have long argued that widespread use of EHRs can make medicine safer by alerting doctors to potential medical errors, though critics counter that software glitches and user errors may cause new varieties of medical mistakes.
How closely the FDA should watch over the digital medical record revolution has been controversial for years. The agency’s interest in the issue perked up after Congress decided in February 2009 to spend billions of dollars on digital medical records as part of an economic stimulus program.
At the time, many industry groups argued that FDA regulation would “stifle innovation” and stall the national drive to bring medicine into the modern era. Federal officials responsible for doling out billions in subsidies to doctors and hospitals generally sympathized with that view and were skeptical of allowing the FDA to play a role.
The debate became public in February 2010, when Jeffrey Shuren, MD, an FDA official, testified at a public hearing that the agency had tied 6 deaths and more than 200 injuries to health information technology. In all, the FDA said, it had logged 260 reports in the previous 2 years of “malfunctions with the potential for patient harm.”
The agency said the findings were based largely on reports voluntarily submitted to the FDA and suggested “significant clinical implications and public safety issues.” In one case cited, lab tests done in a hospital emergency department were sent to the wrong patient’s file. Since then, several government and private repositories have associated thousands of injuries, near misses, and deaths to EHR technology.
Dr. Shuren said in 2010 that the agency recognized that health information technology had great potential to improve patient care, but also needed oversight to “assure patient safety.”
While some safety proponents agree that EHRs offer tremendous benefits, they also see a greater opportunities to improve their safety.
Dean Sittig, PhD, a professor of bioinformatics and bioengineering at the University of Texas, Houston, said EHRs have improved safety within the health care system, but they have not eliminated errors to the extent that he would have expected. Federal officials were initially pushing for rapid adoption and ‘there wasn’t a lot of interest in talking about things that could go wrong,’ ” Dr. Sittig told KHN and Fortune.
Earlier in March, Gottlieb announced his resignation from the FDA. His last day is scheduled to be April 5.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN correspondents Sarah Jane Tribble, Sydney Lupkin, and Julie Rovner contributed to this report.
“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Dr. Gottlieb said in an interview with Kaiser Health News.
Dr. Gottlieb was responding to “Botched Operation,” a report published March 18 by KHN and Fortune magazine. The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, thousands of reports of deaths, injuries, and near misses linked to EHRs have piled up in databases – including at least one run by the FDA.
Dr. Gottlieb said Congress would need to enact legislation to define when an EHR would require government oversight. He said that the digital records systems, which store a patient’s medical history, don’t fit neatly under the agency’s existing mandate to regulate items such as drugs and medical devices.
Dr. Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren’t the same as for a traditional medical device implanted in a patient. “You need a much different regulatory scheme,” he said.
The 21st Century Cures Act of 2016 excludes the FDA from having oversight over EHRs as a medical device.
Dr. Gottlieb said that health IT companies could add new functions that would improve EHRs, but they have been reluctant to do so because they didn’t want their products to fall under FDA jurisdiction. He added that he was “not calling” for FDA to take over such a duty, however, and suggested that any new approach could be years away. Proponents have long argued that widespread use of EHRs can make medicine safer by alerting doctors to potential medical errors, though critics counter that software glitches and user errors may cause new varieties of medical mistakes.
How closely the FDA should watch over the digital medical record revolution has been controversial for years. The agency’s interest in the issue perked up after Congress decided in February 2009 to spend billions of dollars on digital medical records as part of an economic stimulus program.
At the time, many industry groups argued that FDA regulation would “stifle innovation” and stall the national drive to bring medicine into the modern era. Federal officials responsible for doling out billions in subsidies to doctors and hospitals generally sympathized with that view and were skeptical of allowing the FDA to play a role.
The debate became public in February 2010, when Jeffrey Shuren, MD, an FDA official, testified at a public hearing that the agency had tied 6 deaths and more than 200 injuries to health information technology. In all, the FDA said, it had logged 260 reports in the previous 2 years of “malfunctions with the potential for patient harm.”
The agency said the findings were based largely on reports voluntarily submitted to the FDA and suggested “significant clinical implications and public safety issues.” In one case cited, lab tests done in a hospital emergency department were sent to the wrong patient’s file. Since then, several government and private repositories have associated thousands of injuries, near misses, and deaths to EHR technology.
Dr. Shuren said in 2010 that the agency recognized that health information technology had great potential to improve patient care, but also needed oversight to “assure patient safety.”
While some safety proponents agree that EHRs offer tremendous benefits, they also see a greater opportunities to improve their safety.
Dean Sittig, PhD, a professor of bioinformatics and bioengineering at the University of Texas, Houston, said EHRs have improved safety within the health care system, but they have not eliminated errors to the extent that he would have expected. Federal officials were initially pushing for rapid adoption and ‘there wasn’t a lot of interest in talking about things that could go wrong,’ ” Dr. Sittig told KHN and Fortune.
Earlier in March, Gottlieb announced his resignation from the FDA. His last day is scheduled to be April 5.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN correspondents Sarah Jane Tribble, Sydney Lupkin, and Julie Rovner contributed to this report.
For patients with end-stage liver disease, acute care incurs steep costs
End-of-life care for patients with end-stage liver disease cost more than four of the five most expensive chronic medical conditions, according to the findings of a population-based study in Canada.
During their final year of life, patients with end-stage liver disease incurred a median of $51,191 Canadian dollars in health care costs (interquartile range, $28,510-$86,659) – approximately $2,360 more than ischemic heart disease, $1,830 more than diabetes, $1,600 more than mental health disorders, and $600 more than congestive heart failure, Erin M. Kelly, MD, of the University of Ottawa, and her associates wrote in Clinical Gastroenterology and Hepatology. Only chronic renal disease cost more (median, $55,453). Most health care costs of end-stage liver disease covered the final 90 days of life and were tied to high use of hospital resources, the researchers said.
In the United States, more than 150,000 patients are hospitalized for end-stage liver disease every year at a price tag of $4 billion, Dr. Kelly and her associates noted. This price tag is expected to rise further because of epidemic levels of obesity and related nonalcoholic fatty liver disease. The shortage of livers for transplantation and the fact that many patients with cirrhosis are not transplantation candidates leave many in end-of-life care. Given the lack of population-level data on costs of this care, the researchers studied data for all individuals who died in Ontario – Canada’s largest province – between April 2010 and March 2013. The data source was the Institute for Clinical Evaluative Sciences, a nonprofit group that tracks diagnoses, health care, outcomes, and costs.
Among 264,723 decedents, 5,087 (1.9%) had a diagnosis of end-stage liver disease. These patients died a median of 15 years earlier than other patients (median age of death, 65 vs. 80 years old). During the last year of life, 99% visited the emergency department or were hospitalized, compared with 86% of other patients. Importantly, health care costs for the two groups were similar up until the final 90 days of life, when there was “a clear divergence,” the researchers said. A total of 51% of the costs of the final 12 months of care related to acute care during the final 90 days of life. Consequently, during their last 3 months, patients with end-stage liver disease cost the health care system 46% more than other individuals, the difference remained statistically significant after accounting for demographics and comorbidities, and the picture changed little after excluding transplantation patients and those with hepatocellular carcinoma.
Medical care for patients with end-stage liver disease is complex – often involving serious infections, gastrointestinal bleeding, renal dysfunction, electrolyte disturbances, and worsening encephalopathy – and often involves frequent hospital readmissions, the researchers noted. Nonetheless, the findings highlight the need to consider steps such as advanced care planning and palliative care to help keep patients with end-stage liver disease from dying in acute care settings, they concluded. Such steps “may direct services toward more appropriate sectors, while reducing costs.”
The Ontario Ministry of Health and Long-Term Care supported the work. The researchers reported having no competing interests.
SOURCE: Kelly EM et al. Clin Gastroenterol Hepatol. 2019 Jan 28. doi: 10.1016/j.cgh.2019.01.046.
End-of-life care for patients with end-stage liver disease cost more than four of the five most expensive chronic medical conditions, according to the findings of a population-based study in Canada.
During their final year of life, patients with end-stage liver disease incurred a median of $51,191 Canadian dollars in health care costs (interquartile range, $28,510-$86,659) – approximately $2,360 more than ischemic heart disease, $1,830 more than diabetes, $1,600 more than mental health disorders, and $600 more than congestive heart failure, Erin M. Kelly, MD, of the University of Ottawa, and her associates wrote in Clinical Gastroenterology and Hepatology. Only chronic renal disease cost more (median, $55,453). Most health care costs of end-stage liver disease covered the final 90 days of life and were tied to high use of hospital resources, the researchers said.
In the United States, more than 150,000 patients are hospitalized for end-stage liver disease every year at a price tag of $4 billion, Dr. Kelly and her associates noted. This price tag is expected to rise further because of epidemic levels of obesity and related nonalcoholic fatty liver disease. The shortage of livers for transplantation and the fact that many patients with cirrhosis are not transplantation candidates leave many in end-of-life care. Given the lack of population-level data on costs of this care, the researchers studied data for all individuals who died in Ontario – Canada’s largest province – between April 2010 and March 2013. The data source was the Institute for Clinical Evaluative Sciences, a nonprofit group that tracks diagnoses, health care, outcomes, and costs.
Among 264,723 decedents, 5,087 (1.9%) had a diagnosis of end-stage liver disease. These patients died a median of 15 years earlier than other patients (median age of death, 65 vs. 80 years old). During the last year of life, 99% visited the emergency department or were hospitalized, compared with 86% of other patients. Importantly, health care costs for the two groups were similar up until the final 90 days of life, when there was “a clear divergence,” the researchers said. A total of 51% of the costs of the final 12 months of care related to acute care during the final 90 days of life. Consequently, during their last 3 months, patients with end-stage liver disease cost the health care system 46% more than other individuals, the difference remained statistically significant after accounting for demographics and comorbidities, and the picture changed little after excluding transplantation patients and those with hepatocellular carcinoma.
Medical care for patients with end-stage liver disease is complex – often involving serious infections, gastrointestinal bleeding, renal dysfunction, electrolyte disturbances, and worsening encephalopathy – and often involves frequent hospital readmissions, the researchers noted. Nonetheless, the findings highlight the need to consider steps such as advanced care planning and palliative care to help keep patients with end-stage liver disease from dying in acute care settings, they concluded. Such steps “may direct services toward more appropriate sectors, while reducing costs.”
The Ontario Ministry of Health and Long-Term Care supported the work. The researchers reported having no competing interests.
SOURCE: Kelly EM et al. Clin Gastroenterol Hepatol. 2019 Jan 28. doi: 10.1016/j.cgh.2019.01.046.
End-of-life care for patients with end-stage liver disease cost more than four of the five most expensive chronic medical conditions, according to the findings of a population-based study in Canada.
During their final year of life, patients with end-stage liver disease incurred a median of $51,191 Canadian dollars in health care costs (interquartile range, $28,510-$86,659) – approximately $2,360 more than ischemic heart disease, $1,830 more than diabetes, $1,600 more than mental health disorders, and $600 more than congestive heart failure, Erin M. Kelly, MD, of the University of Ottawa, and her associates wrote in Clinical Gastroenterology and Hepatology. Only chronic renal disease cost more (median, $55,453). Most health care costs of end-stage liver disease covered the final 90 days of life and were tied to high use of hospital resources, the researchers said.
In the United States, more than 150,000 patients are hospitalized for end-stage liver disease every year at a price tag of $4 billion, Dr. Kelly and her associates noted. This price tag is expected to rise further because of epidemic levels of obesity and related nonalcoholic fatty liver disease. The shortage of livers for transplantation and the fact that many patients with cirrhosis are not transplantation candidates leave many in end-of-life care. Given the lack of population-level data on costs of this care, the researchers studied data for all individuals who died in Ontario – Canada’s largest province – between April 2010 and March 2013. The data source was the Institute for Clinical Evaluative Sciences, a nonprofit group that tracks diagnoses, health care, outcomes, and costs.
Among 264,723 decedents, 5,087 (1.9%) had a diagnosis of end-stage liver disease. These patients died a median of 15 years earlier than other patients (median age of death, 65 vs. 80 years old). During the last year of life, 99% visited the emergency department or were hospitalized, compared with 86% of other patients. Importantly, health care costs for the two groups were similar up until the final 90 days of life, when there was “a clear divergence,” the researchers said. A total of 51% of the costs of the final 12 months of care related to acute care during the final 90 days of life. Consequently, during their last 3 months, patients with end-stage liver disease cost the health care system 46% more than other individuals, the difference remained statistically significant after accounting for demographics and comorbidities, and the picture changed little after excluding transplantation patients and those with hepatocellular carcinoma.
Medical care for patients with end-stage liver disease is complex – often involving serious infections, gastrointestinal bleeding, renal dysfunction, electrolyte disturbances, and worsening encephalopathy – and often involves frequent hospital readmissions, the researchers noted. Nonetheless, the findings highlight the need to consider steps such as advanced care planning and palliative care to help keep patients with end-stage liver disease from dying in acute care settings, they concluded. Such steps “may direct services toward more appropriate sectors, while reducing costs.”
The Ontario Ministry of Health and Long-Term Care supported the work. The researchers reported having no competing interests.
SOURCE: Kelly EM et al. Clin Gastroenterol Hepatol. 2019 Jan 28. doi: 10.1016/j.cgh.2019.01.046.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
MedPAC puts Part B reference pricing, binding arbitration on the table
Much of the presentation, offered during the commission’s March meeting, was general ideas with more work to come in terms of fleshing out the details. An ambitious goal of having something ready for the commission’s June 2019 report to Congress was set.
The policy recommendations for reference pricing, to be used when multiple similar drugs are available, and binding arbitration, to be used on new entrants to the market with limited or no competition, are being designed to work with the previously recommended drug value program, but could be implemented on their own.
In general, the reference pricing policy would set a maximum payment rate for a group of drugs with similar health effects based on the minimum, median, or other point along the range of prices for all drugs in that group. Providers would be incentivized to choose a lower-cost alternative when clinically appropriate.
Beneficiaries who still want access to a higher-cost drug would be on the hook for the difference through cost-sharing mechanisms.
MedPAC staff presented two options for setting the reference price. One would be to establish the price based on internal Medicare data. The other would take international pricing into consideration.
Binding arbitration, which is already a component of the drug value program, would be expanded. In the program described by staff, Medicare and the manufacturer would each come to the table with a price and the arbitrator (either an individual or a panel) would set one price.
Potential cost savings from one or both programs was not addressed
“It seems like an important thing for us to understand in order to know the potential impact ... through these two levers that work on different parts of the spend problem,” said Commissioner Dana Safran, head of measurement for the health care venture formed by Amazon, Berkshire Hathaway, and JPMorgan Chase.
Staff said it would work on making that determination.
Commissioners raised additional questions on operational details.
Marjorie Ginsburg, founding executive director of the Center for Healthcare Decisions Inc. in Sacramento, Calif., questioned what would happen if a manufacturer declined to participate in the arbitration process and whether that would mean Medicare would not cover a drug in that circumstance.
Jay Crosson, MD, noted that “Congress would have to … figure out how to deal with that circumstance. ... We would not want to end up with a system that would deny coverage” of effective medications for Medicare beneficiaries.
Another area affecting both issues was the potential for cross subsidization of drugs.
Jonathan Perlin, MD, president of clinical services and chief medical officer of HCA Healthcare of Nashville, Tenn., questioned whether this could open a door for a provider buying at a cheaper government price and using the drugs across patients not from Medicare or whether it could lead to higher prices being charged to commercial payers.
MedPAC staff member Kim Neuman said that “there would need to be some back end reconciliations that would happen to ensure that the stock that was then administered to Medicare patients was provided at a price that was no higher than that ceiling. ... We haven’t scoped out implications for other payers.”
Commissioner Kathy Buto, independent consultant and former vice president of global health policy at Johnson & Johnson, inquired about whether a drug would be made available upon launch while reference pricing or arbitration processes were in progress.
Commissioners also inquired as to how the reference pricing aspects will be operationalized into conversations between the doctor and the patient.
Ms. Buto also cautioned that using a reference pricing scheme could alter the dynamic of pricing competition that has companies competing against a reference price rather than doing what they can to lower prices beyond that.
Much of the presentation, offered during the commission’s March meeting, was general ideas with more work to come in terms of fleshing out the details. An ambitious goal of having something ready for the commission’s June 2019 report to Congress was set.
The policy recommendations for reference pricing, to be used when multiple similar drugs are available, and binding arbitration, to be used on new entrants to the market with limited or no competition, are being designed to work with the previously recommended drug value program, but could be implemented on their own.
In general, the reference pricing policy would set a maximum payment rate for a group of drugs with similar health effects based on the minimum, median, or other point along the range of prices for all drugs in that group. Providers would be incentivized to choose a lower-cost alternative when clinically appropriate.
Beneficiaries who still want access to a higher-cost drug would be on the hook for the difference through cost-sharing mechanisms.
MedPAC staff presented two options for setting the reference price. One would be to establish the price based on internal Medicare data. The other would take international pricing into consideration.
Binding arbitration, which is already a component of the drug value program, would be expanded. In the program described by staff, Medicare and the manufacturer would each come to the table with a price and the arbitrator (either an individual or a panel) would set one price.
Potential cost savings from one or both programs was not addressed
“It seems like an important thing for us to understand in order to know the potential impact ... through these two levers that work on different parts of the spend problem,” said Commissioner Dana Safran, head of measurement for the health care venture formed by Amazon, Berkshire Hathaway, and JPMorgan Chase.
Staff said it would work on making that determination.
Commissioners raised additional questions on operational details.
Marjorie Ginsburg, founding executive director of the Center for Healthcare Decisions Inc. in Sacramento, Calif., questioned what would happen if a manufacturer declined to participate in the arbitration process and whether that would mean Medicare would not cover a drug in that circumstance.
Jay Crosson, MD, noted that “Congress would have to … figure out how to deal with that circumstance. ... We would not want to end up with a system that would deny coverage” of effective medications for Medicare beneficiaries.
Another area affecting both issues was the potential for cross subsidization of drugs.
Jonathan Perlin, MD, president of clinical services and chief medical officer of HCA Healthcare of Nashville, Tenn., questioned whether this could open a door for a provider buying at a cheaper government price and using the drugs across patients not from Medicare or whether it could lead to higher prices being charged to commercial payers.
MedPAC staff member Kim Neuman said that “there would need to be some back end reconciliations that would happen to ensure that the stock that was then administered to Medicare patients was provided at a price that was no higher than that ceiling. ... We haven’t scoped out implications for other payers.”
Commissioner Kathy Buto, independent consultant and former vice president of global health policy at Johnson & Johnson, inquired about whether a drug would be made available upon launch while reference pricing or arbitration processes were in progress.
Commissioners also inquired as to how the reference pricing aspects will be operationalized into conversations between the doctor and the patient.
Ms. Buto also cautioned that using a reference pricing scheme could alter the dynamic of pricing competition that has companies competing against a reference price rather than doing what they can to lower prices beyond that.
Much of the presentation, offered during the commission’s March meeting, was general ideas with more work to come in terms of fleshing out the details. An ambitious goal of having something ready for the commission’s June 2019 report to Congress was set.
The policy recommendations for reference pricing, to be used when multiple similar drugs are available, and binding arbitration, to be used on new entrants to the market with limited or no competition, are being designed to work with the previously recommended drug value program, but could be implemented on their own.
In general, the reference pricing policy would set a maximum payment rate for a group of drugs with similar health effects based on the minimum, median, or other point along the range of prices for all drugs in that group. Providers would be incentivized to choose a lower-cost alternative when clinically appropriate.
Beneficiaries who still want access to a higher-cost drug would be on the hook for the difference through cost-sharing mechanisms.
MedPAC staff presented two options for setting the reference price. One would be to establish the price based on internal Medicare data. The other would take international pricing into consideration.
Binding arbitration, which is already a component of the drug value program, would be expanded. In the program described by staff, Medicare and the manufacturer would each come to the table with a price and the arbitrator (either an individual or a panel) would set one price.
Potential cost savings from one or both programs was not addressed
“It seems like an important thing for us to understand in order to know the potential impact ... through these two levers that work on different parts of the spend problem,” said Commissioner Dana Safran, head of measurement for the health care venture formed by Amazon, Berkshire Hathaway, and JPMorgan Chase.
Staff said it would work on making that determination.
Commissioners raised additional questions on operational details.
Marjorie Ginsburg, founding executive director of the Center for Healthcare Decisions Inc. in Sacramento, Calif., questioned what would happen if a manufacturer declined to participate in the arbitration process and whether that would mean Medicare would not cover a drug in that circumstance.
Jay Crosson, MD, noted that “Congress would have to … figure out how to deal with that circumstance. ... We would not want to end up with a system that would deny coverage” of effective medications for Medicare beneficiaries.
Another area affecting both issues was the potential for cross subsidization of drugs.
Jonathan Perlin, MD, president of clinical services and chief medical officer of HCA Healthcare of Nashville, Tenn., questioned whether this could open a door for a provider buying at a cheaper government price and using the drugs across patients not from Medicare or whether it could lead to higher prices being charged to commercial payers.
MedPAC staff member Kim Neuman said that “there would need to be some back end reconciliations that would happen to ensure that the stock that was then administered to Medicare patients was provided at a price that was no higher than that ceiling. ... We haven’t scoped out implications for other payers.”
Commissioner Kathy Buto, independent consultant and former vice president of global health policy at Johnson & Johnson, inquired about whether a drug would be made available upon launch while reference pricing or arbitration processes were in progress.
Commissioners also inquired as to how the reference pricing aspects will be operationalized into conversations between the doctor and the patient.
Ms. Buto also cautioned that using a reference pricing scheme could alter the dynamic of pricing competition that has companies competing against a reference price rather than doing what they can to lower prices beyond that.
REPORTING FROM A MEDPAC MEETING