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Top reads from the CHEST journal portfolio
Malnutrition in critically ill patients, MODE trial findings, and guideline alignment in COPD
Journal CHEST® | The Association Between Malnutrition and High Protein Treatment on Outcomes in Critically Ill Patients
By: Charles Chin Han Lew, PhD, et al
Current international critical care guidelines based on expert opinion recommend high protein treatment (average 1.6 g/kg/d) for critically ill patients diagnosed with preexisting malnutrition to improve clinical outcomes. This multicenter, randomized controlled clinical trial investigated the effects of high vs usual protein treatment in 1,301 critically ill patients across 16 countries. Preexisting malnutrition was independently associated with the primary outcome of slower time to discharge alive (TTDA) (adjusted hazard ratio, 0.81; 95% CI, 0.67-0.98). However, high protein treatment in patients with and without preexisting malnutrition was not associated with TTDA (adjusted hazard ratios of 0.84 [95% CI, 0.63-1.11] and 0.97 [95% CI, 0.77-1.21]). Furthermore, no effect modification was observed (ratio of adjusted hazard ratio, 0.84; 95% CI, 0.58-1.20).
Most importantly, this study demonstrated an association between malnutrition and slower TTDA; however, this association was not modified by high protein treatment. This research challenges current international critical care nutrition guidelines.
– Commentary by Mary Jo S. Farmer, MD, PhD, FCCP, Member of the CHEST Physician Editorial Board
CHEST® Critical Care | Protocol and Statistical Analysis Plan for the Mode of Ventilation During Critical Illness (MODE) Trial
By: Kevin P. Seitz, MD, et al
The Mode of Ventilation During Critical Illness (MODE) trial is a cluster-randomized, multiple-crossover pilot study conducted in a medical ICU exploring how different mechanical ventilation modes affect ventilator-free days in critically ill patients. This trial aims to determine which ventilation mode maximizes the days patients spend alive without invasive ventilation. By switching between ventilation modes each month, the study ensures a thorough assessment under uniform clinical conditions. The trial’s protocol and statistical analysis plan were defined before the end of enrollment, which bolsters the rigor, reproducibility, and transparency of the findings. Initial findings indicate the necessity for an expanded, multicenter trial to definitively identify the optimal ventilation mode, as current data do not universally prefer one method over others. This research has significant implications for clinical practice, potentially altering mechanical ventilation guidelines and improving patient outcomes by reducing the time spent on mechanical ventilation.
– Commentary by Dharani Narendra, MD, FCCP, Member of the CHEST Physician Editorial Board
CHEST® Pulmonary | Guideline Alignment and Medication Concordance in COPD
By: Meredith A. Chase, MD, MHS, et al
Over the past 10 years, a number of studies from generalists and specialists have consistently shown a lack of compliance between physician prescriptions and the Global Initiative for Chronic Obstructive Lung Disease strategy’s recommendations. This study aligns with prior research conducted in the same field. The inappropriate use of maintenance inhalers and the excessive use of inhaled corticosteroids are contributing factors to the skyrocketing expenses of managing COPD despite a slight decrease in prevalence. Overall, the results of all these studies are somewhat unsettling.
Nonetheless, there are a number of factors that are either unavoidable or difficult to address. First, primary care providers (PCPs) are less knowledgeable about the most recent recommendations and guidelines than specialists are. Second, the managed care companies and their PCPs are sometimes reluctant to refer patients to a specialist, resulting in delayed diagnosis and, at times, wrong diagnosis and mismanagement. Third, managed health care organizations have limited drugs for managing COPD on their formularies, limiting the ability of the provider to prescribe guideline-recommended treatments. Lastly, and very regrettably, the number of primary care doctors is decreasing, which is influencing patients’ ability to connect with someone who possesses the clinical expertise to assist them.
Future studies, projects, and endeavors ought to focus on solutions that could lessen these obstacles and provide patients and physicians more education, authority, and autonomy.
– Commentary by Humayun Anjum, MD, FCCP, Member of the CHEST Physician Editorial Board
Malnutrition in critically ill patients, MODE trial findings, and guideline alignment in COPD
Malnutrition in critically ill patients, MODE trial findings, and guideline alignment in COPD
Journal CHEST® | The Association Between Malnutrition and High Protein Treatment on Outcomes in Critically Ill Patients
By: Charles Chin Han Lew, PhD, et al
Current international critical care guidelines based on expert opinion recommend high protein treatment (average 1.6 g/kg/d) for critically ill patients diagnosed with preexisting malnutrition to improve clinical outcomes. This multicenter, randomized controlled clinical trial investigated the effects of high vs usual protein treatment in 1,301 critically ill patients across 16 countries. Preexisting malnutrition was independently associated with the primary outcome of slower time to discharge alive (TTDA) (adjusted hazard ratio, 0.81; 95% CI, 0.67-0.98). However, high protein treatment in patients with and without preexisting malnutrition was not associated with TTDA (adjusted hazard ratios of 0.84 [95% CI, 0.63-1.11] and 0.97 [95% CI, 0.77-1.21]). Furthermore, no effect modification was observed (ratio of adjusted hazard ratio, 0.84; 95% CI, 0.58-1.20).
Most importantly, this study demonstrated an association between malnutrition and slower TTDA; however, this association was not modified by high protein treatment. This research challenges current international critical care nutrition guidelines.
– Commentary by Mary Jo S. Farmer, MD, PhD, FCCP, Member of the CHEST Physician Editorial Board
CHEST® Critical Care | Protocol and Statistical Analysis Plan for the Mode of Ventilation During Critical Illness (MODE) Trial
By: Kevin P. Seitz, MD, et al
The Mode of Ventilation During Critical Illness (MODE) trial is a cluster-randomized, multiple-crossover pilot study conducted in a medical ICU exploring how different mechanical ventilation modes affect ventilator-free days in critically ill patients. This trial aims to determine which ventilation mode maximizes the days patients spend alive without invasive ventilation. By switching between ventilation modes each month, the study ensures a thorough assessment under uniform clinical conditions. The trial’s protocol and statistical analysis plan were defined before the end of enrollment, which bolsters the rigor, reproducibility, and transparency of the findings. Initial findings indicate the necessity for an expanded, multicenter trial to definitively identify the optimal ventilation mode, as current data do not universally prefer one method over others. This research has significant implications for clinical practice, potentially altering mechanical ventilation guidelines and improving patient outcomes by reducing the time spent on mechanical ventilation.
– Commentary by Dharani Narendra, MD, FCCP, Member of the CHEST Physician Editorial Board
CHEST® Pulmonary | Guideline Alignment and Medication Concordance in COPD
By: Meredith A. Chase, MD, MHS, et al
Over the past 10 years, a number of studies from generalists and specialists have consistently shown a lack of compliance between physician prescriptions and the Global Initiative for Chronic Obstructive Lung Disease strategy’s recommendations. This study aligns with prior research conducted in the same field. The inappropriate use of maintenance inhalers and the excessive use of inhaled corticosteroids are contributing factors to the skyrocketing expenses of managing COPD despite a slight decrease in prevalence. Overall, the results of all these studies are somewhat unsettling.
Nonetheless, there are a number of factors that are either unavoidable or difficult to address. First, primary care providers (PCPs) are less knowledgeable about the most recent recommendations and guidelines than specialists are. Second, the managed care companies and their PCPs are sometimes reluctant to refer patients to a specialist, resulting in delayed diagnosis and, at times, wrong diagnosis and mismanagement. Third, managed health care organizations have limited drugs for managing COPD on their formularies, limiting the ability of the provider to prescribe guideline-recommended treatments. Lastly, and very regrettably, the number of primary care doctors is decreasing, which is influencing patients’ ability to connect with someone who possesses the clinical expertise to assist them.
Future studies, projects, and endeavors ought to focus on solutions that could lessen these obstacles and provide patients and physicians more education, authority, and autonomy.
– Commentary by Humayun Anjum, MD, FCCP, Member of the CHEST Physician Editorial Board
Journal CHEST® | The Association Between Malnutrition and High Protein Treatment on Outcomes in Critically Ill Patients
By: Charles Chin Han Lew, PhD, et al
Current international critical care guidelines based on expert opinion recommend high protein treatment (average 1.6 g/kg/d) for critically ill patients diagnosed with preexisting malnutrition to improve clinical outcomes. This multicenter, randomized controlled clinical trial investigated the effects of high vs usual protein treatment in 1,301 critically ill patients across 16 countries. Preexisting malnutrition was independently associated with the primary outcome of slower time to discharge alive (TTDA) (adjusted hazard ratio, 0.81; 95% CI, 0.67-0.98). However, high protein treatment in patients with and without preexisting malnutrition was not associated with TTDA (adjusted hazard ratios of 0.84 [95% CI, 0.63-1.11] and 0.97 [95% CI, 0.77-1.21]). Furthermore, no effect modification was observed (ratio of adjusted hazard ratio, 0.84; 95% CI, 0.58-1.20).
Most importantly, this study demonstrated an association between malnutrition and slower TTDA; however, this association was not modified by high protein treatment. This research challenges current international critical care nutrition guidelines.
– Commentary by Mary Jo S. Farmer, MD, PhD, FCCP, Member of the CHEST Physician Editorial Board
CHEST® Critical Care | Protocol and Statistical Analysis Plan for the Mode of Ventilation During Critical Illness (MODE) Trial
By: Kevin P. Seitz, MD, et al
The Mode of Ventilation During Critical Illness (MODE) trial is a cluster-randomized, multiple-crossover pilot study conducted in a medical ICU exploring how different mechanical ventilation modes affect ventilator-free days in critically ill patients. This trial aims to determine which ventilation mode maximizes the days patients spend alive without invasive ventilation. By switching between ventilation modes each month, the study ensures a thorough assessment under uniform clinical conditions. The trial’s protocol and statistical analysis plan were defined before the end of enrollment, which bolsters the rigor, reproducibility, and transparency of the findings. Initial findings indicate the necessity for an expanded, multicenter trial to definitively identify the optimal ventilation mode, as current data do not universally prefer one method over others. This research has significant implications for clinical practice, potentially altering mechanical ventilation guidelines and improving patient outcomes by reducing the time spent on mechanical ventilation.
– Commentary by Dharani Narendra, MD, FCCP, Member of the CHEST Physician Editorial Board
CHEST® Pulmonary | Guideline Alignment and Medication Concordance in COPD
By: Meredith A. Chase, MD, MHS, et al
Over the past 10 years, a number of studies from generalists and specialists have consistently shown a lack of compliance between physician prescriptions and the Global Initiative for Chronic Obstructive Lung Disease strategy’s recommendations. This study aligns with prior research conducted in the same field. The inappropriate use of maintenance inhalers and the excessive use of inhaled corticosteroids are contributing factors to the skyrocketing expenses of managing COPD despite a slight decrease in prevalence. Overall, the results of all these studies are somewhat unsettling.
Nonetheless, there are a number of factors that are either unavoidable or difficult to address. First, primary care providers (PCPs) are less knowledgeable about the most recent recommendations and guidelines than specialists are. Second, the managed care companies and their PCPs are sometimes reluctant to refer patients to a specialist, resulting in delayed diagnosis and, at times, wrong diagnosis and mismanagement. Third, managed health care organizations have limited drugs for managing COPD on their formularies, limiting the ability of the provider to prescribe guideline-recommended treatments. Lastly, and very regrettably, the number of primary care doctors is decreasing, which is influencing patients’ ability to connect with someone who possesses the clinical expertise to assist them.
Future studies, projects, and endeavors ought to focus on solutions that could lessen these obstacles and provide patients and physicians more education, authority, and autonomy.
– Commentary by Humayun Anjum, MD, FCCP, Member of the CHEST Physician Editorial Board
Complementing, not competing
As we enter summer, it’s hard to believe that we’re halfway through my presidency. Registration for CHEST 2024 (October 6 to 9) is now open, and October will be here before we know it.
I’m happy to share that we received more than 4,000 abstract and case report submissions from clinicians at all stages of their careers, and, for the first year, we had a dedicated category to solicit submissions from physician assistants (PAs), nurse practitioners (NPs), respiratory therapists, and other members of the broader health care team.
In both my practice and my time as CHEST President, I’ve been reflecting on the benefits of the multidisciplinary team—especially in the ICU. Because this is a setting that relies heavily on a team aspect, every member of the care team is a great asset.
CHEST is working to ensure that all integral members of our professional health care teams have the resources they need to best serve our patients. We encourage advanced practice providers (APPs) to apply to serve on our committees during the current open call, and we recently launched a dedicated APP Intersection column, called APP Intersection, within this publication to elevate diverse perspectives. I anticipate more is on the horizon.
In my experience, I have seen tremendous success in partnering with and complementing each other, rather than competing for space when caring for a patient. Each and every one of us shares the same goal of providing the best patient care, and we each bring our own strengths.
Our future is ripe with opportunities to better serve the whole care team—MDs, PAs, NPs, and more—and it starts with recognizing the needs of everyone within the organization. To help CHEST better serve our members, I encourage you to take a short survey about your professional hurdles.
And please, do not hesitate to contact me (president@chestnet.org) with suggestions or just to introduce yourself.
All the best,
Jack
As we enter summer, it’s hard to believe that we’re halfway through my presidency. Registration for CHEST 2024 (October 6 to 9) is now open, and October will be here before we know it.
I’m happy to share that we received more than 4,000 abstract and case report submissions from clinicians at all stages of their careers, and, for the first year, we had a dedicated category to solicit submissions from physician assistants (PAs), nurse practitioners (NPs), respiratory therapists, and other members of the broader health care team.
In both my practice and my time as CHEST President, I’ve been reflecting on the benefits of the multidisciplinary team—especially in the ICU. Because this is a setting that relies heavily on a team aspect, every member of the care team is a great asset.
CHEST is working to ensure that all integral members of our professional health care teams have the resources they need to best serve our patients. We encourage advanced practice providers (APPs) to apply to serve on our committees during the current open call, and we recently launched a dedicated APP Intersection column, called APP Intersection, within this publication to elevate diverse perspectives. I anticipate more is on the horizon.
In my experience, I have seen tremendous success in partnering with and complementing each other, rather than competing for space when caring for a patient. Each and every one of us shares the same goal of providing the best patient care, and we each bring our own strengths.
Our future is ripe with opportunities to better serve the whole care team—MDs, PAs, NPs, and more—and it starts with recognizing the needs of everyone within the organization. To help CHEST better serve our members, I encourage you to take a short survey about your professional hurdles.
And please, do not hesitate to contact me (president@chestnet.org) with suggestions or just to introduce yourself.
All the best,
Jack
As we enter summer, it’s hard to believe that we’re halfway through my presidency. Registration for CHEST 2024 (October 6 to 9) is now open, and October will be here before we know it.
I’m happy to share that we received more than 4,000 abstract and case report submissions from clinicians at all stages of their careers, and, for the first year, we had a dedicated category to solicit submissions from physician assistants (PAs), nurse practitioners (NPs), respiratory therapists, and other members of the broader health care team.
In both my practice and my time as CHEST President, I’ve been reflecting on the benefits of the multidisciplinary team—especially in the ICU. Because this is a setting that relies heavily on a team aspect, every member of the care team is a great asset.
CHEST is working to ensure that all integral members of our professional health care teams have the resources they need to best serve our patients. We encourage advanced practice providers (APPs) to apply to serve on our committees during the current open call, and we recently launched a dedicated APP Intersection column, called APP Intersection, within this publication to elevate diverse perspectives. I anticipate more is on the horizon.
In my experience, I have seen tremendous success in partnering with and complementing each other, rather than competing for space when caring for a patient. Each and every one of us shares the same goal of providing the best patient care, and we each bring our own strengths.
Our future is ripe with opportunities to better serve the whole care team—MDs, PAs, NPs, and more—and it starts with recognizing the needs of everyone within the organization. To help CHEST better serve our members, I encourage you to take a short survey about your professional hurdles.
And please, do not hesitate to contact me (president@chestnet.org) with suggestions or just to introduce yourself.
All the best,
Jack
Nurse practitioners as advocates for health policy and patient care
APP INTERSECTION
In the intricate tapestry of health care, the roles of advanced practice registered nurses, also known as nurse practitioners (NPs), have evolved beyond the confines of clinical settings.
The journey into the realm of nursing often begins with a passion for healing and caring for others. However, for many, this path frequently leads to overcoming barriers to patient care, restrictions to practice, and lengthy red tape in the face of care teams that do not fully understand the scope and role of the NP.
Delving into health policy intricacies, efforts focus on understanding how legislative decisions directly impact patient care. Involvement in advocacy aims to improve health care access, promote patient-centered policies, and reduce disparities in the workforce and patient care.
Achieving sound primary care for people with multiple comorbid conditions requires the skills and abilities of all members of the health care workforce, including NPs.1 NPs have assumed an increasing role in recent decades as primary care providers for people with chronic diseases, while national trends show few physicians entering and staying in primary care.2,3,4,5 NPs are the nation’s fastest-growing primary care workforce, with nearly 90% of them trained to deliver primary care.6,7 Yet, NPs continue to experience reduced reimbursement for services compared with their physician counterparts.
Barriers to practice reduce the productivity and capacity of these health care professionals. Not permitting NPs to practice to the full extent of their licensure and education decreases the types and amounts of health care services that can be provided for people who need care.8As noted in the Future of Nursing 2020-2030 report, this restriction also has significant implications for addressing the disparities in access to health care between rural and urban areas. A recent systemic review revealed that full practice authority is associated with higher numbers of NPs in rural areas and in primary care where there is a shortage of physicians. Full practice authority is associated with increased access to care and utilization of health care services, lower cost of care, and no decrease in quality of care.9,10 As stated in the National Council of State Boards of Nursing 2022 Environmental Scan, regulators and nurse leaders are responsible for upholding rules and regulations of nursing practice as well as ensuring that standards of care are met and patients are protected.11
Of equal importance is regulator awareness of the degree to which barriers continue to impact NP practice and limit aspects of care that directly influence care quality and access. Nursing leaders can have a significant impact on removing nonregulatory barriers to practice, such as changing outdated hospital bylaws that restrict NP practice. In turn, regulators can support efforts to remove unnecessary barriers to NP practice.
Fueled by experience in reduced practice, NPs become catalysts for change, transcending the role of health care providers. At the core of the NP role lies a commitment to patient advocacy. Beyond diagnosing and treating illnesses, NPs champion patients’ rights, ensuring their voices in health care decision-making. Advocacy efforts range from expanding access to essential services to promoting preventive care and fighting discrimination. By embracing roles as caregivers and agents of change, NPs can help the health care system emerge equitable, accessible, and patient-centric.
Ms. Kavanaugh is Assistant Dean of Graduate Nursing, University of Mount Saint Vincent, Pulmonary Critical Care Nurse Practitioner, Stamford Hospital.
References
1. McMenamin, A., Turi, E., Schlak, A., & Poghosyan, L. (2023). A Systematic Review of Outcomes Related to Nurse Practitioner-Delivered Primary Care for Multiple Chronic Conditions. Medical care research and review: MCRR, 80(6), 563–581. https://doi.org/10.1177/10775587231186720
2. Fraze T, Briggs A, Whitcomb E, Peck K, & Meara E (2020). Role of nurse practitioners in caring for patients with complex health needs. Medical Care, 58(10), 853–860. 10.1097/mlr.0000000000001364
3. Xue Y, Goodwin J, Adhikari D, Raji M, & Kuo Y (2017). Trends in primary care provision to medicare beneficiaries by physicians, nurse practitioners, or physician assistants: 2008–2014. Journal of Primary Care & Community Health, 8(4), 256–263. 10.1177/2150131917736634
4. Buerhaus P (2018). Nurse practitioners: A solution to America’s primary care crisis. American Enterprise Institute. https://www.aei.org/research-products/report/nurse-practitioners-a-solution-to-americas-primary-care-crisis/
5. Xue Y, Goodwin J, Adhikari D, Raji M, & Kuo Y (2017). Trends in primary care provision to medicare beneficiaries by physicians, nurse practitioners, or physician assistants: 2008–2014. Journal of Primary Care & Community Health, 8(4), 256–263. 10.1177/2150131917736634
6. American Association of Nurse Practitioners. (2022). Nurse practitioners in primary care. https://www.aanp.org/advocacy/advocacy-resource/position-statements/nurse-practitioners-in-primary-care
7. Auerbach, D. I. (2012). Will the NP workforce grow in the future? New forecasts and implications for healthcare delivery. Medical Care, 50(7), 606-610. doi: http://dx.doi.org/10.1097/MLR.0b013e318249d6e7
8. National Academy of Medicine . The National Academies Press; 2021. The future of nursing 2020-2030: Charting a path to achieve health equity.
9. Yang BK, Trinkoff AM, Zito JM, Burcu M, Safer DJ, Storr CL, Johantgen ME, & Idzik S (2017). Nurse practitioner independent practice authority and mental health service delivery in U.S. Community Health Centers. Psychiatric Services, 68(10), 1032–1038. 10.1176/appi.ps.201600495
10. Xue Y., Kannan V., Greener E., Smith J.A., Brasch J., Johnson B.A., Spetz J. Full scope-of-practice regulation is associated with higher supply of nurse practitioners in rural and primary care health professional shortage counties. Journal of Nursing Regulation. 2018;8(4):5–13. doi: 10.1016/S2155-8256(17)30176-X.
11. National Council of State Boards of Nursing The NCSBN 2022 environmental scan: Resiliency, achievement, and public protection. Journal of Nursing Regulation. 2022;12:S3–S55. doi: 10.1016/S2155-8256(22)00015-1.
APP INTERSECTION
In the intricate tapestry of health care, the roles of advanced practice registered nurses, also known as nurse practitioners (NPs), have evolved beyond the confines of clinical settings.
The journey into the realm of nursing often begins with a passion for healing and caring for others. However, for many, this path frequently leads to overcoming barriers to patient care, restrictions to practice, and lengthy red tape in the face of care teams that do not fully understand the scope and role of the NP.
Delving into health policy intricacies, efforts focus on understanding how legislative decisions directly impact patient care. Involvement in advocacy aims to improve health care access, promote patient-centered policies, and reduce disparities in the workforce and patient care.
Achieving sound primary care for people with multiple comorbid conditions requires the skills and abilities of all members of the health care workforce, including NPs.1 NPs have assumed an increasing role in recent decades as primary care providers for people with chronic diseases, while national trends show few physicians entering and staying in primary care.2,3,4,5 NPs are the nation’s fastest-growing primary care workforce, with nearly 90% of them trained to deliver primary care.6,7 Yet, NPs continue to experience reduced reimbursement for services compared with their physician counterparts.
Barriers to practice reduce the productivity and capacity of these health care professionals. Not permitting NPs to practice to the full extent of their licensure and education decreases the types and amounts of health care services that can be provided for people who need care.8As noted in the Future of Nursing 2020-2030 report, this restriction also has significant implications for addressing the disparities in access to health care between rural and urban areas. A recent systemic review revealed that full practice authority is associated with higher numbers of NPs in rural areas and in primary care where there is a shortage of physicians. Full practice authority is associated with increased access to care and utilization of health care services, lower cost of care, and no decrease in quality of care.9,10 As stated in the National Council of State Boards of Nursing 2022 Environmental Scan, regulators and nurse leaders are responsible for upholding rules and regulations of nursing practice as well as ensuring that standards of care are met and patients are protected.11
Of equal importance is regulator awareness of the degree to which barriers continue to impact NP practice and limit aspects of care that directly influence care quality and access. Nursing leaders can have a significant impact on removing nonregulatory barriers to practice, such as changing outdated hospital bylaws that restrict NP practice. In turn, regulators can support efforts to remove unnecessary barriers to NP practice.
Fueled by experience in reduced practice, NPs become catalysts for change, transcending the role of health care providers. At the core of the NP role lies a commitment to patient advocacy. Beyond diagnosing and treating illnesses, NPs champion patients’ rights, ensuring their voices in health care decision-making. Advocacy efforts range from expanding access to essential services to promoting preventive care and fighting discrimination. By embracing roles as caregivers and agents of change, NPs can help the health care system emerge equitable, accessible, and patient-centric.
Ms. Kavanaugh is Assistant Dean of Graduate Nursing, University of Mount Saint Vincent, Pulmonary Critical Care Nurse Practitioner, Stamford Hospital.
References
1. McMenamin, A., Turi, E., Schlak, A., & Poghosyan, L. (2023). A Systematic Review of Outcomes Related to Nurse Practitioner-Delivered Primary Care for Multiple Chronic Conditions. Medical care research and review: MCRR, 80(6), 563–581. https://doi.org/10.1177/10775587231186720
2. Fraze T, Briggs A, Whitcomb E, Peck K, & Meara E (2020). Role of nurse practitioners in caring for patients with complex health needs. Medical Care, 58(10), 853–860. 10.1097/mlr.0000000000001364
3. Xue Y, Goodwin J, Adhikari D, Raji M, & Kuo Y (2017). Trends in primary care provision to medicare beneficiaries by physicians, nurse practitioners, or physician assistants: 2008–2014. Journal of Primary Care & Community Health, 8(4), 256–263. 10.1177/2150131917736634
4. Buerhaus P (2018). Nurse practitioners: A solution to America’s primary care crisis. American Enterprise Institute. https://www.aei.org/research-products/report/nurse-practitioners-a-solution-to-americas-primary-care-crisis/
5. Xue Y, Goodwin J, Adhikari D, Raji M, & Kuo Y (2017). Trends in primary care provision to medicare beneficiaries by physicians, nurse practitioners, or physician assistants: 2008–2014. Journal of Primary Care & Community Health, 8(4), 256–263. 10.1177/2150131917736634
6. American Association of Nurse Practitioners. (2022). Nurse practitioners in primary care. https://www.aanp.org/advocacy/advocacy-resource/position-statements/nurse-practitioners-in-primary-care
7. Auerbach, D. I. (2012). Will the NP workforce grow in the future? New forecasts and implications for healthcare delivery. Medical Care, 50(7), 606-610. doi: http://dx.doi.org/10.1097/MLR.0b013e318249d6e7
8. National Academy of Medicine . The National Academies Press; 2021. The future of nursing 2020-2030: Charting a path to achieve health equity.
9. Yang BK, Trinkoff AM, Zito JM, Burcu M, Safer DJ, Storr CL, Johantgen ME, & Idzik S (2017). Nurse practitioner independent practice authority and mental health service delivery in U.S. Community Health Centers. Psychiatric Services, 68(10), 1032–1038. 10.1176/appi.ps.201600495
10. Xue Y., Kannan V., Greener E., Smith J.A., Brasch J., Johnson B.A., Spetz J. Full scope-of-practice regulation is associated with higher supply of nurse practitioners in rural and primary care health professional shortage counties. Journal of Nursing Regulation. 2018;8(4):5–13. doi: 10.1016/S2155-8256(17)30176-X.
11. National Council of State Boards of Nursing The NCSBN 2022 environmental scan: Resiliency, achievement, and public protection. Journal of Nursing Regulation. 2022;12:S3–S55. doi: 10.1016/S2155-8256(22)00015-1.
APP INTERSECTION
In the intricate tapestry of health care, the roles of advanced practice registered nurses, also known as nurse practitioners (NPs), have evolved beyond the confines of clinical settings.
The journey into the realm of nursing often begins with a passion for healing and caring for others. However, for many, this path frequently leads to overcoming barriers to patient care, restrictions to practice, and lengthy red tape in the face of care teams that do not fully understand the scope and role of the NP.
Delving into health policy intricacies, efforts focus on understanding how legislative decisions directly impact patient care. Involvement in advocacy aims to improve health care access, promote patient-centered policies, and reduce disparities in the workforce and patient care.
Achieving sound primary care for people with multiple comorbid conditions requires the skills and abilities of all members of the health care workforce, including NPs.1 NPs have assumed an increasing role in recent decades as primary care providers for people with chronic diseases, while national trends show few physicians entering and staying in primary care.2,3,4,5 NPs are the nation’s fastest-growing primary care workforce, with nearly 90% of them trained to deliver primary care.6,7 Yet, NPs continue to experience reduced reimbursement for services compared with their physician counterparts.
Barriers to practice reduce the productivity and capacity of these health care professionals. Not permitting NPs to practice to the full extent of their licensure and education decreases the types and amounts of health care services that can be provided for people who need care.8As noted in the Future of Nursing 2020-2030 report, this restriction also has significant implications for addressing the disparities in access to health care between rural and urban areas. A recent systemic review revealed that full practice authority is associated with higher numbers of NPs in rural areas and in primary care where there is a shortage of physicians. Full practice authority is associated with increased access to care and utilization of health care services, lower cost of care, and no decrease in quality of care.9,10 As stated in the National Council of State Boards of Nursing 2022 Environmental Scan, regulators and nurse leaders are responsible for upholding rules and regulations of nursing practice as well as ensuring that standards of care are met and patients are protected.11
Of equal importance is regulator awareness of the degree to which barriers continue to impact NP practice and limit aspects of care that directly influence care quality and access. Nursing leaders can have a significant impact on removing nonregulatory barriers to practice, such as changing outdated hospital bylaws that restrict NP practice. In turn, regulators can support efforts to remove unnecessary barriers to NP practice.
Fueled by experience in reduced practice, NPs become catalysts for change, transcending the role of health care providers. At the core of the NP role lies a commitment to patient advocacy. Beyond diagnosing and treating illnesses, NPs champion patients’ rights, ensuring their voices in health care decision-making. Advocacy efforts range from expanding access to essential services to promoting preventive care and fighting discrimination. By embracing roles as caregivers and agents of change, NPs can help the health care system emerge equitable, accessible, and patient-centric.
Ms. Kavanaugh is Assistant Dean of Graduate Nursing, University of Mount Saint Vincent, Pulmonary Critical Care Nurse Practitioner, Stamford Hospital.
References
1. McMenamin, A., Turi, E., Schlak, A., & Poghosyan, L. (2023). A Systematic Review of Outcomes Related to Nurse Practitioner-Delivered Primary Care for Multiple Chronic Conditions. Medical care research and review: MCRR, 80(6), 563–581. https://doi.org/10.1177/10775587231186720
2. Fraze T, Briggs A, Whitcomb E, Peck K, & Meara E (2020). Role of nurse practitioners in caring for patients with complex health needs. Medical Care, 58(10), 853–860. 10.1097/mlr.0000000000001364
3. Xue Y, Goodwin J, Adhikari D, Raji M, & Kuo Y (2017). Trends in primary care provision to medicare beneficiaries by physicians, nurse practitioners, or physician assistants: 2008–2014. Journal of Primary Care & Community Health, 8(4), 256–263. 10.1177/2150131917736634
4. Buerhaus P (2018). Nurse practitioners: A solution to America’s primary care crisis. American Enterprise Institute. https://www.aei.org/research-products/report/nurse-practitioners-a-solution-to-americas-primary-care-crisis/
5. Xue Y, Goodwin J, Adhikari D, Raji M, & Kuo Y (2017). Trends in primary care provision to medicare beneficiaries by physicians, nurse practitioners, or physician assistants: 2008–2014. Journal of Primary Care & Community Health, 8(4), 256–263. 10.1177/2150131917736634
6. American Association of Nurse Practitioners. (2022). Nurse practitioners in primary care. https://www.aanp.org/advocacy/advocacy-resource/position-statements/nurse-practitioners-in-primary-care
7. Auerbach, D. I. (2012). Will the NP workforce grow in the future? New forecasts and implications for healthcare delivery. Medical Care, 50(7), 606-610. doi: http://dx.doi.org/10.1097/MLR.0b013e318249d6e7
8. National Academy of Medicine . The National Academies Press; 2021. The future of nursing 2020-2030: Charting a path to achieve health equity.
9. Yang BK, Trinkoff AM, Zito JM, Burcu M, Safer DJ, Storr CL, Johantgen ME, & Idzik S (2017). Nurse practitioner independent practice authority and mental health service delivery in U.S. Community Health Centers. Psychiatric Services, 68(10), 1032–1038. 10.1176/appi.ps.201600495
10. Xue Y., Kannan V., Greener E., Smith J.A., Brasch J., Johnson B.A., Spetz J. Full scope-of-practice regulation is associated with higher supply of nurse practitioners in rural and primary care health professional shortage counties. Journal of Nursing Regulation. 2018;8(4):5–13. doi: 10.1016/S2155-8256(17)30176-X.
11. National Council of State Boards of Nursing The NCSBN 2022 environmental scan: Resiliency, achievement, and public protection. Journal of Nursing Regulation. 2022;12:S3–S55. doi: 10.1016/S2155-8256(22)00015-1.
Military burn pits: Their evidence and implications for respiratory health
Military service is a hazard-ridden profession. It’s easy to recognize the direct dangers from warfighting, such as gunfire and explosions, but the risks from environmental, chemical, and other occupational exposures can be harder to see.
Combustion-based waste management systems, otherwise known as “burn pits,” were used in deployed environments by the US military from the 1990s to the early 2010s. These burn pits were commonly used to eliminate plastics, electronics, munitions, metals, wood, chemicals, and even human waste. At the height of the recent conflicts in Afghanistan, Iraq, and other southwest Asia locations, more than 70% of military installations employed at least one, and nearly 4 million service members were exposed to some degree to their emissions.
Reports of burn pits being related to organic disease have garnered widespread media attention. Initially, this came through anecdotal reports of post-deployment respiratory symptoms. Over time, the conditions attributed to burn pits expanded to include newly diagnosed respiratory diseases and malignancies.
Ultimately, Congress passed the 2022 Promise to Address Comprehensive Toxins (PACT) Act, presumptively linking more than 20 diagnoses to burn pits. The PACT Act provides countless veterans access to low-cost or free medical care for their respective conditions.
What do we know about burn pits and deployment-related respiratory disease?
Data from the Millennium Cohort Study noted an approximately 40% increase in respiratory symptoms among individuals returning from deployment but no increase in the frequency of diagnosed respiratory diseases.1 This study and others definitively established a temporal relationship between deployment and respiratory symptoms. Soon after, a retrospective, observational study of service members with post-deployment respiratory symptoms found a high prevalence of constrictive bronchiolitis (CB) identified by lung biopsy.2 Patients in this group reported exposure to burn pits and a sulfur mine fire in the Mosul area while deployed. Most had normal imaging and pulmonary function testing before biopsy, confounding the clinical significance of the CB finding. The publication of this report led to increased investigation of respiratory function during and after deployment.
In a series of prospective studies that included full pulmonary function testing, impulse oscillometry, cardiopulmonary exercise testing, bronchoscopy, and, occasionally, lung biopsy to evaluate post-deployment dyspnea, only a small minority received a diagnosis of clinically significant lung disease.3,4 Additionally, when comparing spirometry and impulse oscillometry results from before and after deployment, no decline in lung function was observed in a population of service members reporting regular burn pit exposure.5 These studies suggest that at the population level, deployment does not lead to abnormalities in the structure and function of the respiratory system.
The National Academies of Sciences published two separate reviews of burn pit exposure and outcomes in 2011 and 2020.6,7 They found insufficient evidence to support a causal relationship between burn pit exposure and pulmonary disease. They highlighted studies on the composition of emissions from the area surrounding the largest military burn pit in Iraq. Levels of particulate matter, volatile organic compounds, and polycyclic aromatic hydrocarbons were elevated when compared with those of a typical American city but were similar to the pollution levels seen in the region at the time. Given these findings, they suggested ambient air pollution may have contributed more to clinically significant disease than burn pit emissions.
How do we interpret this mixed data?
At the population level, we have yet to find conclusive data directly linking burn pit exposure to the development of any respiratory disease. Does this mean that burn pits are not harmful?
Not necessarily. Research on outcomes related to burn pit exposure is challenging given the heterogeneity in exposure volume. Much of the research is retrospective and subject to recall bias. Relationships may be distorted, and the precision of reported symptoms and exposure levels is altered. Given these challenges, it’s unsurprising that evidence of causality has yet to be proven. In addition, some portion of service members has been diagnosed with respiratory disease that could be related to burn pit exposure.
What is now indisputable is that deployment to southwest Asia leads to an increase in respiratory complaints. Whether veteran respiratory symptoms are due to burn pits, ambient pollution, environmental particulate matter, or dust storms is less clinically relevant. These symptoms require attention, investigation, and management.
What does this mean for the future medical care of service members and veterans?
Many veterans with post-deployment respiratory symptoms undergo extensive evaluations without obtaining a definitive diagnosis. A recent consensus statement on deployment-related respiratory symptoms provides a framework for evaluation in such cases.8 In keeping with that statement, we recommend veterans be referred to centers with expertise in this field, such as the Department of Veterans Affairs (VA) or military health centers, when deployment-related respiratory symptoms are reported. When the evaluation does not lead to a treatable diagnosis, these centers can provide multidisciplinary care to address the symptoms of dyspnea, cough, fatigue, and exercise intolerance to improve functional status.
Despite uncertainty in the evidence or challenges in diagnosis, both the Department of Defense (DoD) and VA remain fully committed to addressing the health concerns of service members and veterans. Notably, the VA has already screened more than 5 million veterans for toxic military exposures in accordance with the PACT Act and is providing ongoing screening and care for veterans with post-deployment respiratory symptoms. Furthermore, the DoD and VA have dedicated large portions of their research budgets to investigating the impacts of exposures during military service and optimizing the care of those with respiratory symptoms. With these commitments to patient care and research, our veterans’ respiratory health can now be optimized, and future risks can be mitigated.
Dr. Haynes is Fellow, Pulmonary and Critical Care Medicine, Walter Reed National Military Medical Center, Assistant Professor of Medicine, Uniformed Services University. Dr. Nations is Pulmonary and Critical Care Medicine, Deputy Chief of Staff for Operations, Washington DC VA Medical Center, Associate Professor of Medicine, Uniformed Services University.
References
1. Smith B, Wong CA, Smith TC, Boyko EJ, Gackstetter GD; Margaret A. K. Ryan for the Millennium Cohort Study Team. Newly reported respiratory symptoms and conditions among military personnel deployed to Iraq and Afghanistan: a prospective population-based study. Am J Epidemiol. 2009;170(11):1433-1442. Preprint. Posted online October 22, 2009. PMID: 19850627. doi: 10.1093/aje/kwp287
2. King MS, Eisenberg R, Newman JH, et al. Constrictive bronchiolitis in soldiers returning from Iraq and Afghanistan. N Engl J Med. 2011;365(3):222-230. Erratum in: N Engl J Med. 2011;365(18):1749. PMID: 21774710; PMCID: PMC3296566. doi: 10.1056/NEJMoa1101388
3. Morris MJ, Dodson DW, Lucero PF, et al. Study of active duty military for pulmonary disease related to environmental deployment exposures (STAMPEDE). Am J Respir Crit Care Med. 2014;190(1):77-84. PMID: 24922562. doi: 10.1164/rccm.201402-0372OC
4. Morris MJ, Walter RJ, McCann ET, et al. Clinical evaluation of deployed military personnel with chronic respiratory symptoms: study of active duty military for pulmonary disease related to environmental deployment exposures (STAMPEDE) III. Chest. 2020;157(6):1559-1567. Preprint. Posted online February 1, 2020. PMID: 32017933. doi: 10.1016/j.chest.2020.01.024
5. Morris MJ, Skabelund AJ, Rawlins FA 3rd, Gallup RA, Aden JK, Holley AB. Study of active duty military personnel for environmental deployment exposures: pre- and post-deployment spirometry (STAMPEDE II). Respir Care. 2019;64(5):536-544. Preprint. Posted online January 8, 2019.PMID: 30622173. doi: 10.4187/respcare.06396
6. Institute of Medicine. Long-Term Health Consequences of Exposure to Burn Pits in Iraq and Afghanistan. The National Academies Press; 2011. https://doi.org/10.17226/13209
7. National Academies of Sciences, Engineering, and Medicine. Respiratory Health Effects of Airborne Hazards Exposures in the Southwest Asia Theater of Military Operations. The National Academies Press; 2020. https://doi.org/10.17226/25837
8. Falvo MJ, Sotolongo AM, Osterholzer JJ, et al. Consensus statements on deployment-related respiratory disease, inclusive of constrictive bronchiolitis: a modified Delphi study. Chest. 2023;163(3):599-609. Preprint. Posted November 4, 2022. PMID: 36343686; PMCID: PMC10154857. doi: 10.1016/j.chest.2022.10.031
Military service is a hazard-ridden profession. It’s easy to recognize the direct dangers from warfighting, such as gunfire and explosions, but the risks from environmental, chemical, and other occupational exposures can be harder to see.
Combustion-based waste management systems, otherwise known as “burn pits,” were used in deployed environments by the US military from the 1990s to the early 2010s. These burn pits were commonly used to eliminate plastics, electronics, munitions, metals, wood, chemicals, and even human waste. At the height of the recent conflicts in Afghanistan, Iraq, and other southwest Asia locations, more than 70% of military installations employed at least one, and nearly 4 million service members were exposed to some degree to their emissions.
Reports of burn pits being related to organic disease have garnered widespread media attention. Initially, this came through anecdotal reports of post-deployment respiratory symptoms. Over time, the conditions attributed to burn pits expanded to include newly diagnosed respiratory diseases and malignancies.
Ultimately, Congress passed the 2022 Promise to Address Comprehensive Toxins (PACT) Act, presumptively linking more than 20 diagnoses to burn pits. The PACT Act provides countless veterans access to low-cost or free medical care for their respective conditions.
What do we know about burn pits and deployment-related respiratory disease?
Data from the Millennium Cohort Study noted an approximately 40% increase in respiratory symptoms among individuals returning from deployment but no increase in the frequency of diagnosed respiratory diseases.1 This study and others definitively established a temporal relationship between deployment and respiratory symptoms. Soon after, a retrospective, observational study of service members with post-deployment respiratory symptoms found a high prevalence of constrictive bronchiolitis (CB) identified by lung biopsy.2 Patients in this group reported exposure to burn pits and a sulfur mine fire in the Mosul area while deployed. Most had normal imaging and pulmonary function testing before biopsy, confounding the clinical significance of the CB finding. The publication of this report led to increased investigation of respiratory function during and after deployment.
In a series of prospective studies that included full pulmonary function testing, impulse oscillometry, cardiopulmonary exercise testing, bronchoscopy, and, occasionally, lung biopsy to evaluate post-deployment dyspnea, only a small minority received a diagnosis of clinically significant lung disease.3,4 Additionally, when comparing spirometry and impulse oscillometry results from before and after deployment, no decline in lung function was observed in a population of service members reporting regular burn pit exposure.5 These studies suggest that at the population level, deployment does not lead to abnormalities in the structure and function of the respiratory system.
The National Academies of Sciences published two separate reviews of burn pit exposure and outcomes in 2011 and 2020.6,7 They found insufficient evidence to support a causal relationship between burn pit exposure and pulmonary disease. They highlighted studies on the composition of emissions from the area surrounding the largest military burn pit in Iraq. Levels of particulate matter, volatile organic compounds, and polycyclic aromatic hydrocarbons were elevated when compared with those of a typical American city but were similar to the pollution levels seen in the region at the time. Given these findings, they suggested ambient air pollution may have contributed more to clinically significant disease than burn pit emissions.
How do we interpret this mixed data?
At the population level, we have yet to find conclusive data directly linking burn pit exposure to the development of any respiratory disease. Does this mean that burn pits are not harmful?
Not necessarily. Research on outcomes related to burn pit exposure is challenging given the heterogeneity in exposure volume. Much of the research is retrospective and subject to recall bias. Relationships may be distorted, and the precision of reported symptoms and exposure levels is altered. Given these challenges, it’s unsurprising that evidence of causality has yet to be proven. In addition, some portion of service members has been diagnosed with respiratory disease that could be related to burn pit exposure.
What is now indisputable is that deployment to southwest Asia leads to an increase in respiratory complaints. Whether veteran respiratory symptoms are due to burn pits, ambient pollution, environmental particulate matter, or dust storms is less clinically relevant. These symptoms require attention, investigation, and management.
What does this mean for the future medical care of service members and veterans?
Many veterans with post-deployment respiratory symptoms undergo extensive evaluations without obtaining a definitive diagnosis. A recent consensus statement on deployment-related respiratory symptoms provides a framework for evaluation in such cases.8 In keeping with that statement, we recommend veterans be referred to centers with expertise in this field, such as the Department of Veterans Affairs (VA) or military health centers, when deployment-related respiratory symptoms are reported. When the evaluation does not lead to a treatable diagnosis, these centers can provide multidisciplinary care to address the symptoms of dyspnea, cough, fatigue, and exercise intolerance to improve functional status.
Despite uncertainty in the evidence or challenges in diagnosis, both the Department of Defense (DoD) and VA remain fully committed to addressing the health concerns of service members and veterans. Notably, the VA has already screened more than 5 million veterans for toxic military exposures in accordance with the PACT Act and is providing ongoing screening and care for veterans with post-deployment respiratory symptoms. Furthermore, the DoD and VA have dedicated large portions of their research budgets to investigating the impacts of exposures during military service and optimizing the care of those with respiratory symptoms. With these commitments to patient care and research, our veterans’ respiratory health can now be optimized, and future risks can be mitigated.
Dr. Haynes is Fellow, Pulmonary and Critical Care Medicine, Walter Reed National Military Medical Center, Assistant Professor of Medicine, Uniformed Services University. Dr. Nations is Pulmonary and Critical Care Medicine, Deputy Chief of Staff for Operations, Washington DC VA Medical Center, Associate Professor of Medicine, Uniformed Services University.
References
1. Smith B, Wong CA, Smith TC, Boyko EJ, Gackstetter GD; Margaret A. K. Ryan for the Millennium Cohort Study Team. Newly reported respiratory symptoms and conditions among military personnel deployed to Iraq and Afghanistan: a prospective population-based study. Am J Epidemiol. 2009;170(11):1433-1442. Preprint. Posted online October 22, 2009. PMID: 19850627. doi: 10.1093/aje/kwp287
2. King MS, Eisenberg R, Newman JH, et al. Constrictive bronchiolitis in soldiers returning from Iraq and Afghanistan. N Engl J Med. 2011;365(3):222-230. Erratum in: N Engl J Med. 2011;365(18):1749. PMID: 21774710; PMCID: PMC3296566. doi: 10.1056/NEJMoa1101388
3. Morris MJ, Dodson DW, Lucero PF, et al. Study of active duty military for pulmonary disease related to environmental deployment exposures (STAMPEDE). Am J Respir Crit Care Med. 2014;190(1):77-84. PMID: 24922562. doi: 10.1164/rccm.201402-0372OC
4. Morris MJ, Walter RJ, McCann ET, et al. Clinical evaluation of deployed military personnel with chronic respiratory symptoms: study of active duty military for pulmonary disease related to environmental deployment exposures (STAMPEDE) III. Chest. 2020;157(6):1559-1567. Preprint. Posted online February 1, 2020. PMID: 32017933. doi: 10.1016/j.chest.2020.01.024
5. Morris MJ, Skabelund AJ, Rawlins FA 3rd, Gallup RA, Aden JK, Holley AB. Study of active duty military personnel for environmental deployment exposures: pre- and post-deployment spirometry (STAMPEDE II). Respir Care. 2019;64(5):536-544. Preprint. Posted online January 8, 2019.PMID: 30622173. doi: 10.4187/respcare.06396
6. Institute of Medicine. Long-Term Health Consequences of Exposure to Burn Pits in Iraq and Afghanistan. The National Academies Press; 2011. https://doi.org/10.17226/13209
7. National Academies of Sciences, Engineering, and Medicine. Respiratory Health Effects of Airborne Hazards Exposures in the Southwest Asia Theater of Military Operations. The National Academies Press; 2020. https://doi.org/10.17226/25837
8. Falvo MJ, Sotolongo AM, Osterholzer JJ, et al. Consensus statements on deployment-related respiratory disease, inclusive of constrictive bronchiolitis: a modified Delphi study. Chest. 2023;163(3):599-609. Preprint. Posted November 4, 2022. PMID: 36343686; PMCID: PMC10154857. doi: 10.1016/j.chest.2022.10.031
Military service is a hazard-ridden profession. It’s easy to recognize the direct dangers from warfighting, such as gunfire and explosions, but the risks from environmental, chemical, and other occupational exposures can be harder to see.
Combustion-based waste management systems, otherwise known as “burn pits,” were used in deployed environments by the US military from the 1990s to the early 2010s. These burn pits were commonly used to eliminate plastics, electronics, munitions, metals, wood, chemicals, and even human waste. At the height of the recent conflicts in Afghanistan, Iraq, and other southwest Asia locations, more than 70% of military installations employed at least one, and nearly 4 million service members were exposed to some degree to their emissions.
Reports of burn pits being related to organic disease have garnered widespread media attention. Initially, this came through anecdotal reports of post-deployment respiratory symptoms. Over time, the conditions attributed to burn pits expanded to include newly diagnosed respiratory diseases and malignancies.
Ultimately, Congress passed the 2022 Promise to Address Comprehensive Toxins (PACT) Act, presumptively linking more than 20 diagnoses to burn pits. The PACT Act provides countless veterans access to low-cost or free medical care for their respective conditions.
What do we know about burn pits and deployment-related respiratory disease?
Data from the Millennium Cohort Study noted an approximately 40% increase in respiratory symptoms among individuals returning from deployment but no increase in the frequency of diagnosed respiratory diseases.1 This study and others definitively established a temporal relationship between deployment and respiratory symptoms. Soon after, a retrospective, observational study of service members with post-deployment respiratory symptoms found a high prevalence of constrictive bronchiolitis (CB) identified by lung biopsy.2 Patients in this group reported exposure to burn pits and a sulfur mine fire in the Mosul area while deployed. Most had normal imaging and pulmonary function testing before biopsy, confounding the clinical significance of the CB finding. The publication of this report led to increased investigation of respiratory function during and after deployment.
In a series of prospective studies that included full pulmonary function testing, impulse oscillometry, cardiopulmonary exercise testing, bronchoscopy, and, occasionally, lung biopsy to evaluate post-deployment dyspnea, only a small minority received a diagnosis of clinically significant lung disease.3,4 Additionally, when comparing spirometry and impulse oscillometry results from before and after deployment, no decline in lung function was observed in a population of service members reporting regular burn pit exposure.5 These studies suggest that at the population level, deployment does not lead to abnormalities in the structure and function of the respiratory system.
The National Academies of Sciences published two separate reviews of burn pit exposure and outcomes in 2011 and 2020.6,7 They found insufficient evidence to support a causal relationship between burn pit exposure and pulmonary disease. They highlighted studies on the composition of emissions from the area surrounding the largest military burn pit in Iraq. Levels of particulate matter, volatile organic compounds, and polycyclic aromatic hydrocarbons were elevated when compared with those of a typical American city but were similar to the pollution levels seen in the region at the time. Given these findings, they suggested ambient air pollution may have contributed more to clinically significant disease than burn pit emissions.
How do we interpret this mixed data?
At the population level, we have yet to find conclusive data directly linking burn pit exposure to the development of any respiratory disease. Does this mean that burn pits are not harmful?
Not necessarily. Research on outcomes related to burn pit exposure is challenging given the heterogeneity in exposure volume. Much of the research is retrospective and subject to recall bias. Relationships may be distorted, and the precision of reported symptoms and exposure levels is altered. Given these challenges, it’s unsurprising that evidence of causality has yet to be proven. In addition, some portion of service members has been diagnosed with respiratory disease that could be related to burn pit exposure.
What is now indisputable is that deployment to southwest Asia leads to an increase in respiratory complaints. Whether veteran respiratory symptoms are due to burn pits, ambient pollution, environmental particulate matter, or dust storms is less clinically relevant. These symptoms require attention, investigation, and management.
What does this mean for the future medical care of service members and veterans?
Many veterans with post-deployment respiratory symptoms undergo extensive evaluations without obtaining a definitive diagnosis. A recent consensus statement on deployment-related respiratory symptoms provides a framework for evaluation in such cases.8 In keeping with that statement, we recommend veterans be referred to centers with expertise in this field, such as the Department of Veterans Affairs (VA) or military health centers, when deployment-related respiratory symptoms are reported. When the evaluation does not lead to a treatable diagnosis, these centers can provide multidisciplinary care to address the symptoms of dyspnea, cough, fatigue, and exercise intolerance to improve functional status.
Despite uncertainty in the evidence or challenges in diagnosis, both the Department of Defense (DoD) and VA remain fully committed to addressing the health concerns of service members and veterans. Notably, the VA has already screened more than 5 million veterans for toxic military exposures in accordance with the PACT Act and is providing ongoing screening and care for veterans with post-deployment respiratory symptoms. Furthermore, the DoD and VA have dedicated large portions of their research budgets to investigating the impacts of exposures during military service and optimizing the care of those with respiratory symptoms. With these commitments to patient care and research, our veterans’ respiratory health can now be optimized, and future risks can be mitigated.
Dr. Haynes is Fellow, Pulmonary and Critical Care Medicine, Walter Reed National Military Medical Center, Assistant Professor of Medicine, Uniformed Services University. Dr. Nations is Pulmonary and Critical Care Medicine, Deputy Chief of Staff for Operations, Washington DC VA Medical Center, Associate Professor of Medicine, Uniformed Services University.
References
1. Smith B, Wong CA, Smith TC, Boyko EJ, Gackstetter GD; Margaret A. K. Ryan for the Millennium Cohort Study Team. Newly reported respiratory symptoms and conditions among military personnel deployed to Iraq and Afghanistan: a prospective population-based study. Am J Epidemiol. 2009;170(11):1433-1442. Preprint. Posted online October 22, 2009. PMID: 19850627. doi: 10.1093/aje/kwp287
2. King MS, Eisenberg R, Newman JH, et al. Constrictive bronchiolitis in soldiers returning from Iraq and Afghanistan. N Engl J Med. 2011;365(3):222-230. Erratum in: N Engl J Med. 2011;365(18):1749. PMID: 21774710; PMCID: PMC3296566. doi: 10.1056/NEJMoa1101388
3. Morris MJ, Dodson DW, Lucero PF, et al. Study of active duty military for pulmonary disease related to environmental deployment exposures (STAMPEDE). Am J Respir Crit Care Med. 2014;190(1):77-84. PMID: 24922562. doi: 10.1164/rccm.201402-0372OC
4. Morris MJ, Walter RJ, McCann ET, et al. Clinical evaluation of deployed military personnel with chronic respiratory symptoms: study of active duty military for pulmonary disease related to environmental deployment exposures (STAMPEDE) III. Chest. 2020;157(6):1559-1567. Preprint. Posted online February 1, 2020. PMID: 32017933. doi: 10.1016/j.chest.2020.01.024
5. Morris MJ, Skabelund AJ, Rawlins FA 3rd, Gallup RA, Aden JK, Holley AB. Study of active duty military personnel for environmental deployment exposures: pre- and post-deployment spirometry (STAMPEDE II). Respir Care. 2019;64(5):536-544. Preprint. Posted online January 8, 2019.PMID: 30622173. doi: 10.4187/respcare.06396
6. Institute of Medicine. Long-Term Health Consequences of Exposure to Burn Pits in Iraq and Afghanistan. The National Academies Press; 2011. https://doi.org/10.17226/13209
7. National Academies of Sciences, Engineering, and Medicine. Respiratory Health Effects of Airborne Hazards Exposures in the Southwest Asia Theater of Military Operations. The National Academies Press; 2020. https://doi.org/10.17226/25837
8. Falvo MJ, Sotolongo AM, Osterholzer JJ, et al. Consensus statements on deployment-related respiratory disease, inclusive of constrictive bronchiolitis: a modified Delphi study. Chest. 2023;163(3):599-609. Preprint. Posted November 4, 2022. PMID: 36343686; PMCID: PMC10154857. doi: 10.1016/j.chest.2022.10.031
Hospital-onset sepsis: Why the brouhaha?
A 47-year-old woman with a history of cirrhosis is admitted with an acute kidney injury and altered mental status. On the initial workup, there are no signs of infection, and dehydration is determined to be the cause of the kidney injury. There are signs of improvement in the kidney injury with hydration. On hospital day 3, the patient develops a fever (101.9 oF) with accompanying leukocytosis to 14,000. Concerned for infection, the team starts empiric broad spectrum antibiotics for presumed spontaneous bacterial peritonitis. The next day (hospital day 4), a rapid response evaluation is activated as the patient is demonstrating increasing confusion, hypotension with a systolic blood pressure of 70 mm Hg, and elevated lactic acid. The patient receives 1 L of normal saline and transfers to the ICU. The new critical care fellow, who has just read up on sepsis early management bundles, and specifically the Severe Sepsis and Septic Shock Management Bundle (SEP-1), is reviewing the chart and notices a history of multidrug-resistant organisms in her urine cultures from an admission 2 months ago. They ask of the transferring team, “When was time zero, and was the 3-hour bundle completed?”
1 The excessive cost, both of human life and monetary, has led to the commitment of significant resources to sepsis care. Improved recognition and timely intervention for sepsis have led to noteworthy improvement in mortality. Most of this effort has been directed toward patients with sepsis diagnosed in the emergency department (ED) who are presenting with community-onset sepsis (COS). A new entity, called hospital-onset sepsis (HOS), has been described recently, defined by the Centers for Disease Control and Prevention (CDC) as both infection and organ dysfunction developing more than 48 hours after hospital admission.2
A systematic review of 51 studies found approximately 23.6% of all sepsis cases are HOS. The proportion of HOS is even higher (more than 45%) in patients admitted to the ICU with sepsis.3 The outcome for this group remains comparatively poor. The hospital mortality among patients with HOS is 35%, which increases to 52% with progression to septic shock compared with 25% with COS.3 Even after adjusting for baseline factors that make one prone to developing infection in the hospital, a patient developing HOS has three-times a higher risk of dying compared with a patient who never developed sepsis and two-times a higher risk of dying compared with patients with COS.4Furthermore, HOS utilizes more resources with significantly longer ICU and hospital stays and has five-times the hospital cost compared with COS.4
The two most crucial factors in improving sepsis outcomes, as identified by the Surviving Sepsis Campaign guidelines, are: 1) prompt identification and treatment within the first few hours of onset and 2) regular reevaluation of the patient’s response to treatment.
Prompt identification
Diagnosing sepsis in the patient who is hospitalized is challenging. Patients admitted to the hospital often have competing comorbidities, have existing organ failure, or are in a postoperative/intervention state that clouds the application and interpretation of vital sign triggers customarily used to identify sepsis. The positive predictive value for all existing sepsis definitions and diagnostic criteria is dismally low. 5 And while automated electronic sepsis alerts may improve processes of care, they still have poor positive predictive value and have not impacted patient-centered outcomes (mortality or length of stay). Furthermore, the causative microorganisms often associated with hospital-acquired infections are complex, are drug-resistant, and can have courses which further delay identification. Finally, cognitive errors, such as anchoring biases or premature diagnosis closure, can contribute to provider-level identification delays that are only further exacerbated by system issues, such as capacity constraints, staffing issues, and differing paces between wards that tend to impede time-sensitive evaluations and interventions. 4,6,7
Management
The SEP-1 core measure uses a framework of early recognition of infection and completion of the sepsis bundles in a timely manner to improve outcomes. Patients with HOS are less likely than those with COS to receive Centers for Medicare & Medicaid Services SEP-1-compliant care, including timely blood culture collection, initial and repeat lactate testing, and fluid resuscitation.8 The Surviving Sepsis Campaign has explored barriers to managing HOS. Among caregivers, these include delay in recognition, poor communication regarding change in patient status, not prioritizing treatment for sepsis, failure to measure lactate, delayed or no antimicrobial administration, and inadequate fluid resuscitation. In one study, the adherence to SEP-1 for HOS was reported at 13% compared with 39.9% in COS. The differences in initial sepsis management included timing of antimicrobials and fluid resuscitation, which accounted for 23% of observed greater mortality risk among patients with HOS compared with COS.6,8 It remains unclear how these recommendations should be applied and whether some of these recommendations confer the same benefits for patients with HOS as for those with COS. For example, administration of fluids conferred no additional benefit to patients with HOS, while rapid antimicrobial administration was shown to be associated with improved mortality in patients with HOS. Although, the optimal timing for treatment initiation and microbial coverage has not been established.
The path forward
Effective HOS management requires both individual and systematic approaches. How clinicians identify a patient with sepsis must be context-dependent. Although standard criteria exist for defining sepsis, the approach to a patient presenting to the ED from home should differ from that of a patient who has been hospitalized for several days, is postoperative, or is in the ICU on multiple forms of life support. Clinical medicine is context-dependent, and the same principles apply to sepsis management. To address the diagnostic uncertainty of the syndrome, providers must remain vigilant and maintain a clinical “iterative urgency” in diagnosing and managing sepsis. While machine learning algorithms have potential, they still rely on human intervention and interaction to navigate the complexities of HOS diagnosis.
At the system level, survival from sepsis is determined by the speed with which complex medical care is delivered and the effectiveness with which resources and personnel are mobilized and coordinated. The Hospital Sepsis Program Core Elements, released by the CDC, serves as an initial playbook to aid hospitals in establishing comprehensive sepsis improvement programs.
A second invaluable resource for hospitals in sepsis management is the rapid response team (RRT). Studies have shown that resolute RRTs can enhance patient outcomes and compliance with sepsis bundles; though, the composition and scope of these teams are crucial to their effectiveness. Responding to in-hospital emergencies and urgencies without conflicting responsibilities is an essential feature of a successful RRT. Often, they are familiar with bundles, protocols, and documentation, and members of these teams can offer clinical and/or technical expertise as well as support active participation and reengagement with bedside staff, which fosters trust and collaboration. This partnership is key, as these interactions instill a common mission and foster a culture of sepsis improvement that is required to achieve sustained success and improved patient outcomes.
Dr. Dugar is Director, Point-of-Care Ultrasound, Department of Critical Care, Respiratory Institute, Assistant Professor, Cleveland Clinic Lerner College of Medicine, Cleveland, OH. Dr. Jayaprakash is Associate Medical Director, Quality, Emergency Medicine, Physician Lead, Henry Ford Health Sepsis Program. Dr. Reilkoff is Executive Medical Director of Critical Care, M Health Fairview Intensive Care Units, Director of Acting Internship in Critical Care, University of Minnesota Medical School, Associate Professor of Medicine and Surgery, University of Minnesota. Dr. Duggal is Vice-Chair, Department of Critical Care, Respiratory Institute, Director, Critical Care Clinical Research, Associate Professor, Cleveland Clinic Lerner College of Medicine, Cleveland, OH
References
1. Singer M, Deutschman CS, Seymour CW, et al. The third international consensus definitions for sepsis and septic shock (sepsis-3). JAMA. 2016;315(8):801-810.
2. Ginestra JC, Coz Yataco AO, Dugar SP, Dettmer MR. Hospital-onset sepsis warrants expanded investigation and consideration as a unique clinical entity. Chest. 2024;S0012-3692(24):00039-4.
3. Markwart R, Saito H, Harder T, et al. Epidemiology and burden of sepsis acquired in hospitals and intensive care units: a systematic review and meta-analysis. Intensive Care Med. 2020;46(8):1536-1551.
4. Rhee C, Wang R, Zhang Z, et al. Epidemiology of hospital-onset versus community-onset sepsis in U.S. hospitals and association with mortality: a retrospective analysis using electronic clinical data. Crit Care Med. 2019;47(9):1169-1176.
5. Wong A, Otles E, Donnelly JP, et al. External validation of a widely implemented proprietary sepsis prediction model in hospitalized patients. JAMA Intern Med. 2021;181(8):1065-1070.
6. Baghdadi JD, Brook RH, Uslan DZ, et al. Association of a care bundle for early sepsis management with mortality among patients with hospital-onset or community-onset sepsis. JAMA Intern Med. 2020;180(5):707-716.
7. Baghdadi JD, Wong MD, Uslan DZ, et al. Adherence to the SEP-1 sepsis bundle in hospital-onset v. community-onset sepsis: a multicenter retrospective cohort study. J Gen Intern Med. 2020;35(4):1153-1160.
8. Basheer A. Patients with hospital-onset sepsis are less likely to receive sepsis bundle care than those with community-onset sepsis. Evid Based Nurs. 2021;24(3):99.
A 47-year-old woman with a history of cirrhosis is admitted with an acute kidney injury and altered mental status. On the initial workup, there are no signs of infection, and dehydration is determined to be the cause of the kidney injury. There are signs of improvement in the kidney injury with hydration. On hospital day 3, the patient develops a fever (101.9 oF) with accompanying leukocytosis to 14,000. Concerned for infection, the team starts empiric broad spectrum antibiotics for presumed spontaneous bacterial peritonitis. The next day (hospital day 4), a rapid response evaluation is activated as the patient is demonstrating increasing confusion, hypotension with a systolic blood pressure of 70 mm Hg, and elevated lactic acid. The patient receives 1 L of normal saline and transfers to the ICU. The new critical care fellow, who has just read up on sepsis early management bundles, and specifically the Severe Sepsis and Septic Shock Management Bundle (SEP-1), is reviewing the chart and notices a history of multidrug-resistant organisms in her urine cultures from an admission 2 months ago. They ask of the transferring team, “When was time zero, and was the 3-hour bundle completed?”
1 The excessive cost, both of human life and monetary, has led to the commitment of significant resources to sepsis care. Improved recognition and timely intervention for sepsis have led to noteworthy improvement in mortality. Most of this effort has been directed toward patients with sepsis diagnosed in the emergency department (ED) who are presenting with community-onset sepsis (COS). A new entity, called hospital-onset sepsis (HOS), has been described recently, defined by the Centers for Disease Control and Prevention (CDC) as both infection and organ dysfunction developing more than 48 hours after hospital admission.2
A systematic review of 51 studies found approximately 23.6% of all sepsis cases are HOS. The proportion of HOS is even higher (more than 45%) in patients admitted to the ICU with sepsis.3 The outcome for this group remains comparatively poor. The hospital mortality among patients with HOS is 35%, which increases to 52% with progression to septic shock compared with 25% with COS.3 Even after adjusting for baseline factors that make one prone to developing infection in the hospital, a patient developing HOS has three-times a higher risk of dying compared with a patient who never developed sepsis and two-times a higher risk of dying compared with patients with COS.4Furthermore, HOS utilizes more resources with significantly longer ICU and hospital stays and has five-times the hospital cost compared with COS.4
The two most crucial factors in improving sepsis outcomes, as identified by the Surviving Sepsis Campaign guidelines, are: 1) prompt identification and treatment within the first few hours of onset and 2) regular reevaluation of the patient’s response to treatment.
Prompt identification
Diagnosing sepsis in the patient who is hospitalized is challenging. Patients admitted to the hospital often have competing comorbidities, have existing organ failure, or are in a postoperative/intervention state that clouds the application and interpretation of vital sign triggers customarily used to identify sepsis. The positive predictive value for all existing sepsis definitions and diagnostic criteria is dismally low. 5 And while automated electronic sepsis alerts may improve processes of care, they still have poor positive predictive value and have not impacted patient-centered outcomes (mortality or length of stay). Furthermore, the causative microorganisms often associated with hospital-acquired infections are complex, are drug-resistant, and can have courses which further delay identification. Finally, cognitive errors, such as anchoring biases or premature diagnosis closure, can contribute to provider-level identification delays that are only further exacerbated by system issues, such as capacity constraints, staffing issues, and differing paces between wards that tend to impede time-sensitive evaluations and interventions. 4,6,7
Management
The SEP-1 core measure uses a framework of early recognition of infection and completion of the sepsis bundles in a timely manner to improve outcomes. Patients with HOS are less likely than those with COS to receive Centers for Medicare & Medicaid Services SEP-1-compliant care, including timely blood culture collection, initial and repeat lactate testing, and fluid resuscitation.8 The Surviving Sepsis Campaign has explored barriers to managing HOS. Among caregivers, these include delay in recognition, poor communication regarding change in patient status, not prioritizing treatment for sepsis, failure to measure lactate, delayed or no antimicrobial administration, and inadequate fluid resuscitation. In one study, the adherence to SEP-1 for HOS was reported at 13% compared with 39.9% in COS. The differences in initial sepsis management included timing of antimicrobials and fluid resuscitation, which accounted for 23% of observed greater mortality risk among patients with HOS compared with COS.6,8 It remains unclear how these recommendations should be applied and whether some of these recommendations confer the same benefits for patients with HOS as for those with COS. For example, administration of fluids conferred no additional benefit to patients with HOS, while rapid antimicrobial administration was shown to be associated with improved mortality in patients with HOS. Although, the optimal timing for treatment initiation and microbial coverage has not been established.
The path forward
Effective HOS management requires both individual and systematic approaches. How clinicians identify a patient with sepsis must be context-dependent. Although standard criteria exist for defining sepsis, the approach to a patient presenting to the ED from home should differ from that of a patient who has been hospitalized for several days, is postoperative, or is in the ICU on multiple forms of life support. Clinical medicine is context-dependent, and the same principles apply to sepsis management. To address the diagnostic uncertainty of the syndrome, providers must remain vigilant and maintain a clinical “iterative urgency” in diagnosing and managing sepsis. While machine learning algorithms have potential, they still rely on human intervention and interaction to navigate the complexities of HOS diagnosis.
At the system level, survival from sepsis is determined by the speed with which complex medical care is delivered and the effectiveness with which resources and personnel are mobilized and coordinated. The Hospital Sepsis Program Core Elements, released by the CDC, serves as an initial playbook to aid hospitals in establishing comprehensive sepsis improvement programs.
A second invaluable resource for hospitals in sepsis management is the rapid response team (RRT). Studies have shown that resolute RRTs can enhance patient outcomes and compliance with sepsis bundles; though, the composition and scope of these teams are crucial to their effectiveness. Responding to in-hospital emergencies and urgencies without conflicting responsibilities is an essential feature of a successful RRT. Often, they are familiar with bundles, protocols, and documentation, and members of these teams can offer clinical and/or technical expertise as well as support active participation and reengagement with bedside staff, which fosters trust and collaboration. This partnership is key, as these interactions instill a common mission and foster a culture of sepsis improvement that is required to achieve sustained success and improved patient outcomes.
Dr. Dugar is Director, Point-of-Care Ultrasound, Department of Critical Care, Respiratory Institute, Assistant Professor, Cleveland Clinic Lerner College of Medicine, Cleveland, OH. Dr. Jayaprakash is Associate Medical Director, Quality, Emergency Medicine, Physician Lead, Henry Ford Health Sepsis Program. Dr. Reilkoff is Executive Medical Director of Critical Care, M Health Fairview Intensive Care Units, Director of Acting Internship in Critical Care, University of Minnesota Medical School, Associate Professor of Medicine and Surgery, University of Minnesota. Dr. Duggal is Vice-Chair, Department of Critical Care, Respiratory Institute, Director, Critical Care Clinical Research, Associate Professor, Cleveland Clinic Lerner College of Medicine, Cleveland, OH
References
1. Singer M, Deutschman CS, Seymour CW, et al. The third international consensus definitions for sepsis and septic shock (sepsis-3). JAMA. 2016;315(8):801-810.
2. Ginestra JC, Coz Yataco AO, Dugar SP, Dettmer MR. Hospital-onset sepsis warrants expanded investigation and consideration as a unique clinical entity. Chest. 2024;S0012-3692(24):00039-4.
3. Markwart R, Saito H, Harder T, et al. Epidemiology and burden of sepsis acquired in hospitals and intensive care units: a systematic review and meta-analysis. Intensive Care Med. 2020;46(8):1536-1551.
4. Rhee C, Wang R, Zhang Z, et al. Epidemiology of hospital-onset versus community-onset sepsis in U.S. hospitals and association with mortality: a retrospective analysis using electronic clinical data. Crit Care Med. 2019;47(9):1169-1176.
5. Wong A, Otles E, Donnelly JP, et al. External validation of a widely implemented proprietary sepsis prediction model in hospitalized patients. JAMA Intern Med. 2021;181(8):1065-1070.
6. Baghdadi JD, Brook RH, Uslan DZ, et al. Association of a care bundle for early sepsis management with mortality among patients with hospital-onset or community-onset sepsis. JAMA Intern Med. 2020;180(5):707-716.
7. Baghdadi JD, Wong MD, Uslan DZ, et al. Adherence to the SEP-1 sepsis bundle in hospital-onset v. community-onset sepsis: a multicenter retrospective cohort study. J Gen Intern Med. 2020;35(4):1153-1160.
8. Basheer A. Patients with hospital-onset sepsis are less likely to receive sepsis bundle care than those with community-onset sepsis. Evid Based Nurs. 2021;24(3):99.
A 47-year-old woman with a history of cirrhosis is admitted with an acute kidney injury and altered mental status. On the initial workup, there are no signs of infection, and dehydration is determined to be the cause of the kidney injury. There are signs of improvement in the kidney injury with hydration. On hospital day 3, the patient develops a fever (101.9 oF) with accompanying leukocytosis to 14,000. Concerned for infection, the team starts empiric broad spectrum antibiotics for presumed spontaneous bacterial peritonitis. The next day (hospital day 4), a rapid response evaluation is activated as the patient is demonstrating increasing confusion, hypotension with a systolic blood pressure of 70 mm Hg, and elevated lactic acid. The patient receives 1 L of normal saline and transfers to the ICU. The new critical care fellow, who has just read up on sepsis early management bundles, and specifically the Severe Sepsis and Septic Shock Management Bundle (SEP-1), is reviewing the chart and notices a history of multidrug-resistant organisms in her urine cultures from an admission 2 months ago. They ask of the transferring team, “When was time zero, and was the 3-hour bundle completed?”
1 The excessive cost, both of human life and monetary, has led to the commitment of significant resources to sepsis care. Improved recognition and timely intervention for sepsis have led to noteworthy improvement in mortality. Most of this effort has been directed toward patients with sepsis diagnosed in the emergency department (ED) who are presenting with community-onset sepsis (COS). A new entity, called hospital-onset sepsis (HOS), has been described recently, defined by the Centers for Disease Control and Prevention (CDC) as both infection and organ dysfunction developing more than 48 hours after hospital admission.2
A systematic review of 51 studies found approximately 23.6% of all sepsis cases are HOS. The proportion of HOS is even higher (more than 45%) in patients admitted to the ICU with sepsis.3 The outcome for this group remains comparatively poor. The hospital mortality among patients with HOS is 35%, which increases to 52% with progression to septic shock compared with 25% with COS.3 Even after adjusting for baseline factors that make one prone to developing infection in the hospital, a patient developing HOS has three-times a higher risk of dying compared with a patient who never developed sepsis and two-times a higher risk of dying compared with patients with COS.4Furthermore, HOS utilizes more resources with significantly longer ICU and hospital stays and has five-times the hospital cost compared with COS.4
The two most crucial factors in improving sepsis outcomes, as identified by the Surviving Sepsis Campaign guidelines, are: 1) prompt identification and treatment within the first few hours of onset and 2) regular reevaluation of the patient’s response to treatment.
Prompt identification
Diagnosing sepsis in the patient who is hospitalized is challenging. Patients admitted to the hospital often have competing comorbidities, have existing organ failure, or are in a postoperative/intervention state that clouds the application and interpretation of vital sign triggers customarily used to identify sepsis. The positive predictive value for all existing sepsis definitions and diagnostic criteria is dismally low. 5 And while automated electronic sepsis alerts may improve processes of care, they still have poor positive predictive value and have not impacted patient-centered outcomes (mortality or length of stay). Furthermore, the causative microorganisms often associated with hospital-acquired infections are complex, are drug-resistant, and can have courses which further delay identification. Finally, cognitive errors, such as anchoring biases or premature diagnosis closure, can contribute to provider-level identification delays that are only further exacerbated by system issues, such as capacity constraints, staffing issues, and differing paces between wards that tend to impede time-sensitive evaluations and interventions. 4,6,7
Management
The SEP-1 core measure uses a framework of early recognition of infection and completion of the sepsis bundles in a timely manner to improve outcomes. Patients with HOS are less likely than those with COS to receive Centers for Medicare & Medicaid Services SEP-1-compliant care, including timely blood culture collection, initial and repeat lactate testing, and fluid resuscitation.8 The Surviving Sepsis Campaign has explored barriers to managing HOS. Among caregivers, these include delay in recognition, poor communication regarding change in patient status, not prioritizing treatment for sepsis, failure to measure lactate, delayed or no antimicrobial administration, and inadequate fluid resuscitation. In one study, the adherence to SEP-1 for HOS was reported at 13% compared with 39.9% in COS. The differences in initial sepsis management included timing of antimicrobials and fluid resuscitation, which accounted for 23% of observed greater mortality risk among patients with HOS compared with COS.6,8 It remains unclear how these recommendations should be applied and whether some of these recommendations confer the same benefits for patients with HOS as for those with COS. For example, administration of fluids conferred no additional benefit to patients with HOS, while rapid antimicrobial administration was shown to be associated with improved mortality in patients with HOS. Although, the optimal timing for treatment initiation and microbial coverage has not been established.
The path forward
Effective HOS management requires both individual and systematic approaches. How clinicians identify a patient with sepsis must be context-dependent. Although standard criteria exist for defining sepsis, the approach to a patient presenting to the ED from home should differ from that of a patient who has been hospitalized for several days, is postoperative, or is in the ICU on multiple forms of life support. Clinical medicine is context-dependent, and the same principles apply to sepsis management. To address the diagnostic uncertainty of the syndrome, providers must remain vigilant and maintain a clinical “iterative urgency” in diagnosing and managing sepsis. While machine learning algorithms have potential, they still rely on human intervention and interaction to navigate the complexities of HOS diagnosis.
At the system level, survival from sepsis is determined by the speed with which complex medical care is delivered and the effectiveness with which resources and personnel are mobilized and coordinated. The Hospital Sepsis Program Core Elements, released by the CDC, serves as an initial playbook to aid hospitals in establishing comprehensive sepsis improvement programs.
A second invaluable resource for hospitals in sepsis management is the rapid response team (RRT). Studies have shown that resolute RRTs can enhance patient outcomes and compliance with sepsis bundles; though, the composition and scope of these teams are crucial to their effectiveness. Responding to in-hospital emergencies and urgencies without conflicting responsibilities is an essential feature of a successful RRT. Often, they are familiar with bundles, protocols, and documentation, and members of these teams can offer clinical and/or technical expertise as well as support active participation and reengagement with bedside staff, which fosters trust and collaboration. This partnership is key, as these interactions instill a common mission and foster a culture of sepsis improvement that is required to achieve sustained success and improved patient outcomes.
Dr. Dugar is Director, Point-of-Care Ultrasound, Department of Critical Care, Respiratory Institute, Assistant Professor, Cleveland Clinic Lerner College of Medicine, Cleveland, OH. Dr. Jayaprakash is Associate Medical Director, Quality, Emergency Medicine, Physician Lead, Henry Ford Health Sepsis Program. Dr. Reilkoff is Executive Medical Director of Critical Care, M Health Fairview Intensive Care Units, Director of Acting Internship in Critical Care, University of Minnesota Medical School, Associate Professor of Medicine and Surgery, University of Minnesota. Dr. Duggal is Vice-Chair, Department of Critical Care, Respiratory Institute, Director, Critical Care Clinical Research, Associate Professor, Cleveland Clinic Lerner College of Medicine, Cleveland, OH
References
1. Singer M, Deutschman CS, Seymour CW, et al. The third international consensus definitions for sepsis and septic shock (sepsis-3). JAMA. 2016;315(8):801-810.
2. Ginestra JC, Coz Yataco AO, Dugar SP, Dettmer MR. Hospital-onset sepsis warrants expanded investigation and consideration as a unique clinical entity. Chest. 2024;S0012-3692(24):00039-4.
3. Markwart R, Saito H, Harder T, et al. Epidemiology and burden of sepsis acquired in hospitals and intensive care units: a systematic review and meta-analysis. Intensive Care Med. 2020;46(8):1536-1551.
4. Rhee C, Wang R, Zhang Z, et al. Epidemiology of hospital-onset versus community-onset sepsis in U.S. hospitals and association with mortality: a retrospective analysis using electronic clinical data. Crit Care Med. 2019;47(9):1169-1176.
5. Wong A, Otles E, Donnelly JP, et al. External validation of a widely implemented proprietary sepsis prediction model in hospitalized patients. JAMA Intern Med. 2021;181(8):1065-1070.
6. Baghdadi JD, Brook RH, Uslan DZ, et al. Association of a care bundle for early sepsis management with mortality among patients with hospital-onset or community-onset sepsis. JAMA Intern Med. 2020;180(5):707-716.
7. Baghdadi JD, Wong MD, Uslan DZ, et al. Adherence to the SEP-1 sepsis bundle in hospital-onset v. community-onset sepsis: a multicenter retrospective cohort study. J Gen Intern Med. 2020;35(4):1153-1160.
8. Basheer A. Patients with hospital-onset sepsis are less likely to receive sepsis bundle care than those with community-onset sepsis. Evid Based Nurs. 2021;24(3):99.
AGA Clinical Guideline Stresses Patient Preferences in Barrett’s Treatment
Published in Gastroenterology , the clinical practice guideline makes five main recommendations — one strong and four conditional — based on very low to moderate evidence. It also stresses that providers should practice shared decision making according to patient preferences and risk perception.
For the most part, the new guideline is not a significant departure from the way expert endoscopists are currently practicing EET for BE and related neoplasia, gastroenterologist Joel H. Rubenstein, MD, MSc, AGAF, of the Barrett’s Esophagus Program in the Division of Gastroenterology at University of Michigan Medical School at Ann Arbor, said in an interview. One of three first authors of the guideline, Dr. Rubenstein added, “There is, however, considerable variability in how endoscopists practice, and we hope this guidance will serve as a useful resource to refer to for best practices.”
Added gastroenterologist Tarek Sawas, MD, MPH, assistant professor of internal medicine at UT Southwestern Medical Center in Dallas, “We hope the update will provide some clarity for practice and for implementation, while allowing gastroenterologists the freedom to decide what is best for patients based on lesion characteristics.”
Dr. Sawas added that one of the differences in the new guideline relates to the approach to low-grade dysplasia. While earlier guidance favored treatment over surveillance, patient preferences should now be factored into management. “Some patients are risk-averse and prefer to wait and watch, while others place more value on treatment and just want to get on with it,” he said.
When this guideline was circulated for public comment, “the areas prompting the most feedback was on our current suggestions against the routine use of EET in non-dysplastic BE and for the use of either endoscopic mucosal resection [EMR] or endoscopic submucosal dissection [ESD] for resection — with the expectation that the vast majority may be managed with EMR,” Dr. Rubenstein said.
“We felt that ESD would work best for larger lesions,” explained Dr. Sawas. “There aren’t a lot data in this area, just some observational studies, but we should have more data for comparison in the next few years.”
The incidence of esophageal adenocarcinoma continues to rise and an update was deemed in order since the AGA’s last formal guidance on this subject using the systematic GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology was issued in 2011. “In the following time span, there’s been a lot of research, particularly with regard to management of low-grade dysplasia and endoscopic resection techniques,” Dr. Rubenstein said.
Key Recommendations
The 14 guideline panelists made the following suggestions for treatment and implementation based on different levels of certainty of evidence (CoE):
1. If high-grade dysplasia (HGD) is present, EET is recommended over surveillance, with subsequent surveillance performed at 3, 6, and 12 months, and annually thereafter. (Strong recommendation, moderate CoE).
Surveillance endoscopies should obtain targeted tissue samples of visible lesions and random biopsies of the cardia and distal 2 cm of the tubular esophagus.
2. In patients with low-grade dysplasia, EET is also preferred to surveillance. But for those placing a higher value on the certain harms and a lower value on the uncertain benefits of EET for reducing mortality, surveillance endoscopy is a reasonable option. (Conditional recommendation, low CoE).
Following EET, clinicians should perform surveillance at years 1 and 3 after complete eradication of intestinal metaplasia, then revert to the surveillance intervals used in non-dysplastic BE.
3. For non-dysplastic BE, the AGA advises against the routine use of EET. (Conditional recommendation, low CoE).
4. Patients undergoing EET should have resection of visible lesions followed by ablation of the remaining BE segment rather than resection of the entire segment.
In patients with only a small area of BE beyond the visible lesion, endoscopic resection is acceptable and may be preferred over repeated ablation. Radiofrequency ablation is the preferred ablative modality. (Conditional recommendation, very low CoE).
5. For treating visible neoplastic lesions the AGA suggests either EMR or ESD based on lesion characteristics. (Conditional recommendation, very low CoE).
Patients with suspected T1 esophageal adenocarcinoma (EAC) should be considered for EET. Endoscopic resection is recommended over endoscopic ultrasound for distinguishing EAC from HGD and for staging depth of invasion.
The vast majority of neoplastic lesions may be managed with EMR rather than ESD. Patients who have bulky lesions, or lesions highly suspicious of at least T1b invasion and are deemed candidates for endoscopic resection might benefit from ESD over EMR. Those with previously failed EMR might benefit from ESD.
As to the generally low quality of the supporting evidence, Dr. Rubenstein said, “Unfortunately, very few decisions we make in medicine are supported by high certainty of evidence, but we still have to make a decision.” He pointed out that the guideline highlights areas for future research that could help strengthen or change the guideline’s recommendations.
Considering benefits and harms, the panelists concluded that overall CoE across critical desirable outcomes of disease progression to EAC was moderate. Patient-important outcomes informing the harms were strictures, major bleeding perforation, and serious adverse events.
Lifestyle
The guidance also urges providers to counsel BE patients on tobacco cessation and weight loss if needed, and notes the specter of cancer may incentivize patients to make lifestyle changes.
The most common causes of death in EET patients are cardiovascular disease and other cancers, for which tobacco use and obesity are also major risk factors, and tobacco is associated with strictures, the panelists wrote. “The prospect of progression to cancer in patients with dysplastic BE often holds greater valence than prior counseling attempts, and patients may re-commit to such efforts following consultation for EET.”
Going Forward
Areas for future attention include:
- Identifying populations with non-dysplastic BE whose risk warrants EET
- Balancing risk and benefit of EET in low-grade dysplasia
- Randomized controlled trials comparing EMR and ESD in higher-risk lesions
- Optimal management of post-EET pain
- Stricture prevention and control
- Managing resistant/recurrent disease beyond reflux control
- Optimal surveillance and biopsy strategies following EETThis guideline was supported by the National Institutes of Health, the Department of Defense, the Veterans Administration Health Services and Research Division, and the Katy O. and Paul M. Rady Endowed Chair in Esophageal Cancer Research at the University of Colorado.
Dr. Sawas had no competing interests to disclose. Dr. Rubenstein reported research funding from Lucid Diagnostics.
Several other panelists reported research funding or consultation fees from various pharmaceutical and biotechnology companies.
Published in Gastroenterology , the clinical practice guideline makes five main recommendations — one strong and four conditional — based on very low to moderate evidence. It also stresses that providers should practice shared decision making according to patient preferences and risk perception.
For the most part, the new guideline is not a significant departure from the way expert endoscopists are currently practicing EET for BE and related neoplasia, gastroenterologist Joel H. Rubenstein, MD, MSc, AGAF, of the Barrett’s Esophagus Program in the Division of Gastroenterology at University of Michigan Medical School at Ann Arbor, said in an interview. One of three first authors of the guideline, Dr. Rubenstein added, “There is, however, considerable variability in how endoscopists practice, and we hope this guidance will serve as a useful resource to refer to for best practices.”
Added gastroenterologist Tarek Sawas, MD, MPH, assistant professor of internal medicine at UT Southwestern Medical Center in Dallas, “We hope the update will provide some clarity for practice and for implementation, while allowing gastroenterologists the freedom to decide what is best for patients based on lesion characteristics.”
Dr. Sawas added that one of the differences in the new guideline relates to the approach to low-grade dysplasia. While earlier guidance favored treatment over surveillance, patient preferences should now be factored into management. “Some patients are risk-averse and prefer to wait and watch, while others place more value on treatment and just want to get on with it,” he said.
When this guideline was circulated for public comment, “the areas prompting the most feedback was on our current suggestions against the routine use of EET in non-dysplastic BE and for the use of either endoscopic mucosal resection [EMR] or endoscopic submucosal dissection [ESD] for resection — with the expectation that the vast majority may be managed with EMR,” Dr. Rubenstein said.
“We felt that ESD would work best for larger lesions,” explained Dr. Sawas. “There aren’t a lot data in this area, just some observational studies, but we should have more data for comparison in the next few years.”
The incidence of esophageal adenocarcinoma continues to rise and an update was deemed in order since the AGA’s last formal guidance on this subject using the systematic GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology was issued in 2011. “In the following time span, there’s been a lot of research, particularly with regard to management of low-grade dysplasia and endoscopic resection techniques,” Dr. Rubenstein said.
Key Recommendations
The 14 guideline panelists made the following suggestions for treatment and implementation based on different levels of certainty of evidence (CoE):
1. If high-grade dysplasia (HGD) is present, EET is recommended over surveillance, with subsequent surveillance performed at 3, 6, and 12 months, and annually thereafter. (Strong recommendation, moderate CoE).
Surveillance endoscopies should obtain targeted tissue samples of visible lesions and random biopsies of the cardia and distal 2 cm of the tubular esophagus.
2. In patients with low-grade dysplasia, EET is also preferred to surveillance. But for those placing a higher value on the certain harms and a lower value on the uncertain benefits of EET for reducing mortality, surveillance endoscopy is a reasonable option. (Conditional recommendation, low CoE).
Following EET, clinicians should perform surveillance at years 1 and 3 after complete eradication of intestinal metaplasia, then revert to the surveillance intervals used in non-dysplastic BE.
3. For non-dysplastic BE, the AGA advises against the routine use of EET. (Conditional recommendation, low CoE).
4. Patients undergoing EET should have resection of visible lesions followed by ablation of the remaining BE segment rather than resection of the entire segment.
In patients with only a small area of BE beyond the visible lesion, endoscopic resection is acceptable and may be preferred over repeated ablation. Radiofrequency ablation is the preferred ablative modality. (Conditional recommendation, very low CoE).
5. For treating visible neoplastic lesions the AGA suggests either EMR or ESD based on lesion characteristics. (Conditional recommendation, very low CoE).
Patients with suspected T1 esophageal adenocarcinoma (EAC) should be considered for EET. Endoscopic resection is recommended over endoscopic ultrasound for distinguishing EAC from HGD and for staging depth of invasion.
The vast majority of neoplastic lesions may be managed with EMR rather than ESD. Patients who have bulky lesions, or lesions highly suspicious of at least T1b invasion and are deemed candidates for endoscopic resection might benefit from ESD over EMR. Those with previously failed EMR might benefit from ESD.
As to the generally low quality of the supporting evidence, Dr. Rubenstein said, “Unfortunately, very few decisions we make in medicine are supported by high certainty of evidence, but we still have to make a decision.” He pointed out that the guideline highlights areas for future research that could help strengthen or change the guideline’s recommendations.
Considering benefits and harms, the panelists concluded that overall CoE across critical desirable outcomes of disease progression to EAC was moderate. Patient-important outcomes informing the harms were strictures, major bleeding perforation, and serious adverse events.
Lifestyle
The guidance also urges providers to counsel BE patients on tobacco cessation and weight loss if needed, and notes the specter of cancer may incentivize patients to make lifestyle changes.
The most common causes of death in EET patients are cardiovascular disease and other cancers, for which tobacco use and obesity are also major risk factors, and tobacco is associated with strictures, the panelists wrote. “The prospect of progression to cancer in patients with dysplastic BE often holds greater valence than prior counseling attempts, and patients may re-commit to such efforts following consultation for EET.”
Going Forward
Areas for future attention include:
- Identifying populations with non-dysplastic BE whose risk warrants EET
- Balancing risk and benefit of EET in low-grade dysplasia
- Randomized controlled trials comparing EMR and ESD in higher-risk lesions
- Optimal management of post-EET pain
- Stricture prevention and control
- Managing resistant/recurrent disease beyond reflux control
- Optimal surveillance and biopsy strategies following EETThis guideline was supported by the National Institutes of Health, the Department of Defense, the Veterans Administration Health Services and Research Division, and the Katy O. and Paul M. Rady Endowed Chair in Esophageal Cancer Research at the University of Colorado.
Dr. Sawas had no competing interests to disclose. Dr. Rubenstein reported research funding from Lucid Diagnostics.
Several other panelists reported research funding or consultation fees from various pharmaceutical and biotechnology companies.
Published in Gastroenterology , the clinical practice guideline makes five main recommendations — one strong and four conditional — based on very low to moderate evidence. It also stresses that providers should practice shared decision making according to patient preferences and risk perception.
For the most part, the new guideline is not a significant departure from the way expert endoscopists are currently practicing EET for BE and related neoplasia, gastroenterologist Joel H. Rubenstein, MD, MSc, AGAF, of the Barrett’s Esophagus Program in the Division of Gastroenterology at University of Michigan Medical School at Ann Arbor, said in an interview. One of three first authors of the guideline, Dr. Rubenstein added, “There is, however, considerable variability in how endoscopists practice, and we hope this guidance will serve as a useful resource to refer to for best practices.”
Added gastroenterologist Tarek Sawas, MD, MPH, assistant professor of internal medicine at UT Southwestern Medical Center in Dallas, “We hope the update will provide some clarity for practice and for implementation, while allowing gastroenterologists the freedom to decide what is best for patients based on lesion characteristics.”
Dr. Sawas added that one of the differences in the new guideline relates to the approach to low-grade dysplasia. While earlier guidance favored treatment over surveillance, patient preferences should now be factored into management. “Some patients are risk-averse and prefer to wait and watch, while others place more value on treatment and just want to get on with it,” he said.
When this guideline was circulated for public comment, “the areas prompting the most feedback was on our current suggestions against the routine use of EET in non-dysplastic BE and for the use of either endoscopic mucosal resection [EMR] or endoscopic submucosal dissection [ESD] for resection — with the expectation that the vast majority may be managed with EMR,” Dr. Rubenstein said.
“We felt that ESD would work best for larger lesions,” explained Dr. Sawas. “There aren’t a lot data in this area, just some observational studies, but we should have more data for comparison in the next few years.”
The incidence of esophageal adenocarcinoma continues to rise and an update was deemed in order since the AGA’s last formal guidance on this subject using the systematic GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology was issued in 2011. “In the following time span, there’s been a lot of research, particularly with regard to management of low-grade dysplasia and endoscopic resection techniques,” Dr. Rubenstein said.
Key Recommendations
The 14 guideline panelists made the following suggestions for treatment and implementation based on different levels of certainty of evidence (CoE):
1. If high-grade dysplasia (HGD) is present, EET is recommended over surveillance, with subsequent surveillance performed at 3, 6, and 12 months, and annually thereafter. (Strong recommendation, moderate CoE).
Surveillance endoscopies should obtain targeted tissue samples of visible lesions and random biopsies of the cardia and distal 2 cm of the tubular esophagus.
2. In patients with low-grade dysplasia, EET is also preferred to surveillance. But for those placing a higher value on the certain harms and a lower value on the uncertain benefits of EET for reducing mortality, surveillance endoscopy is a reasonable option. (Conditional recommendation, low CoE).
Following EET, clinicians should perform surveillance at years 1 and 3 after complete eradication of intestinal metaplasia, then revert to the surveillance intervals used in non-dysplastic BE.
3. For non-dysplastic BE, the AGA advises against the routine use of EET. (Conditional recommendation, low CoE).
4. Patients undergoing EET should have resection of visible lesions followed by ablation of the remaining BE segment rather than resection of the entire segment.
In patients with only a small area of BE beyond the visible lesion, endoscopic resection is acceptable and may be preferred over repeated ablation. Radiofrequency ablation is the preferred ablative modality. (Conditional recommendation, very low CoE).
5. For treating visible neoplastic lesions the AGA suggests either EMR or ESD based on lesion characteristics. (Conditional recommendation, very low CoE).
Patients with suspected T1 esophageal adenocarcinoma (EAC) should be considered for EET. Endoscopic resection is recommended over endoscopic ultrasound for distinguishing EAC from HGD and for staging depth of invasion.
The vast majority of neoplastic lesions may be managed with EMR rather than ESD. Patients who have bulky lesions, or lesions highly suspicious of at least T1b invasion and are deemed candidates for endoscopic resection might benefit from ESD over EMR. Those with previously failed EMR might benefit from ESD.
As to the generally low quality of the supporting evidence, Dr. Rubenstein said, “Unfortunately, very few decisions we make in medicine are supported by high certainty of evidence, but we still have to make a decision.” He pointed out that the guideline highlights areas for future research that could help strengthen or change the guideline’s recommendations.
Considering benefits and harms, the panelists concluded that overall CoE across critical desirable outcomes of disease progression to EAC was moderate. Patient-important outcomes informing the harms were strictures, major bleeding perforation, and serious adverse events.
Lifestyle
The guidance also urges providers to counsel BE patients on tobacco cessation and weight loss if needed, and notes the specter of cancer may incentivize patients to make lifestyle changes.
The most common causes of death in EET patients are cardiovascular disease and other cancers, for which tobacco use and obesity are also major risk factors, and tobacco is associated with strictures, the panelists wrote. “The prospect of progression to cancer in patients with dysplastic BE often holds greater valence than prior counseling attempts, and patients may re-commit to such efforts following consultation for EET.”
Going Forward
Areas for future attention include:
- Identifying populations with non-dysplastic BE whose risk warrants EET
- Balancing risk and benefit of EET in low-grade dysplasia
- Randomized controlled trials comparing EMR and ESD in higher-risk lesions
- Optimal management of post-EET pain
- Stricture prevention and control
- Managing resistant/recurrent disease beyond reflux control
- Optimal surveillance and biopsy strategies following EETThis guideline was supported by the National Institutes of Health, the Department of Defense, the Veterans Administration Health Services and Research Division, and the Katy O. and Paul M. Rady Endowed Chair in Esophageal Cancer Research at the University of Colorado.
Dr. Sawas had no competing interests to disclose. Dr. Rubenstein reported research funding from Lucid Diagnostics.
Several other panelists reported research funding or consultation fees from various pharmaceutical and biotechnology companies.
FROM GASTROENTEROLOGY
Want a healthy diet? Eat real food, GI physician advises
What exactly is a healthy diet?
Scott Ketover, MD, AGAF, FASGE, will be the first to admit that’s not an easy question to answer. “As much research and information as we have, we don’t really know what a healthy diet is,” said Dr. Ketover, president and CEO of MNGI Digestive Health in Minneapolis, Minnesota. He was recognized by AGA this year with the Distinguished Clinician Award in Private Practice.
When patients ask questions about a healthy diet, Dr. Ketover responds with a dose of common sense: “If it’s food that didn’t exist in the year 1900, don’t eat it.” Your grandmother’s apple pie is fine in moderation, he said, but the apple pie you get at the McDonald’s drive-through could sit on your shelf for 6 months and look the same.
That is not something you should eat, he emphasizes.
“I really do believe though, that what crosses our lips and gets into our GI tract really underlies our entire health. It’s just that we don’t have enough information yet to know how we can coach people in telling them: eat this, not that,” he added.
In an interview, Dr. Ketover spoke more about the link between the gut microbiome and health, and the young patient who inspired him to become a GI physician.
Q: Why did you choose GI?
Dr. Ketover: I was a medical student working on my pediatrics rotation at Children’s Minnesota (Minneapolis Pediatrics Hospital). A 17-year-old young man who had Crohn’s disease really turned this into my lifelong passion. The patient confided in me that when he was 11, he had an ileostomy. He wore an ileostomy bag for 6 years and kept it hidden from all his friends. He was petrified of their knowing. And he told me at the age of 17 that if he knew how hard it was going to be to keep that secret, he would’ve preferred to have died rather than have the ileostomy. That got me thinking a lot about Crohn’s disease, and certainly how it affects patients. It became a very motivating thing for me to be involved in something that could potentially prevent this situation for others.
Today, we have much better treatment for Crohn’s than we did 30 years ago. So that’s all a good thing.
Q: Wellness and therapeutic diets are a specific interest of yours. Can you talk about this?
Dr. Ketover: We talk about things like Cheetos, Twinkies — those are not real foods. I do direct patients to ‘think’ when they go to the grocery store. All the good stuff is in the perimeter of the store. When you walk down the aisles, it’s all the processed food with added chemicals. It’s hard to point at specific things though and say: this is bad for you, but we do know that we should eat real food as often as we can. And I think that will contribute to our knowledge and learning about the intestinal microbiome. Again, we’re really at the beginning of our infancy of this, even though there’s lots of probiotics and things out there that claim to make you healthier. We don’t really know yet. And it’s going to take more time.
Q: What role does diet play in improving the intestinal microbiome?
Dr. Ketover: When you look at people who are healthy and who have low incidence of chronic diseases or inflammatory conditions, obesity, cancer, we’re starting to study their microbiome to see how it differs from people who have those illnesses and conditions and try to understand what the different constituents are of the microbiome. And then the big question is: Okay, so once we know that, how do we take ‘the unhealthy microbiome’ and change it to the ‘healthy microbiome’?
The only method we currently have is fecal transplant for Clostridioides difficile. And that’s just not a feasible way to change the microbiome for most people.
Some studies are going on with this. There’s been laboratory studies done with lab animals that show that fecal transplant can reverse obesity.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Ketover: The biggest challenge these days for medical practices is the relationship with the payer world and prior authorization. Where we’ve seen the greatest impact of prior authorization, unfortunately, is in the Medicare Advantage programs. Payers receive money from the federal government on plans that they can better manage the patient on, rather than Medicare. That results in a tremendous amount of prior authorization.
I get particularly incensed when I see that a lot of payers are practicing medicine without a license and they’re not relying on the professionals who are actually in the exam room with patients and doing the history and physical examination to determine what is an appropriate course of diagnosis or therapy for a patient.
It comes around every January. We have patients who are stable on meds, then their insurance gets renewed and the pharmacy formulary changes. Patients stable on various therapies are either kicked off them, or we have to go through the prior authorization process again for the same patient for the umpteenth time to keep them on a stable therapy.
How do I address that? It’s in conversations with payers and policy makers. There’s a lot going on in Washington, talking about prior authorization. I’m not sure that non-practitioners fully feel the pain that it delivers to patients.
Q: What teacher or mentor had the greatest impact on you?
Dr. Ketover: Phillip M. Kibort, MD, the pediatric physician I worked with as a medical student who really turned me on to GI medicine. We worked together on several patients and I was able to develop an appreciation for the breadth and depth of GI-related abnormalities and diseases and therapies. And I really got excited by the spectrum of opportunity that I would have as a physician to help treat patients with GI illness.
Q: What would you do differently if you had a chance?
Dr. Ketover: I’d travel more both for work and for pleasure. I really enjoy my relationships that I’ve created with lots of other gastroenterologists as well as non-physicians around policy issues. I’m involved in a couple of national organizations that talk to politicians on Capitol Hill and at state houses about patient advocacy. I would have done more of that earlier in my career if I could have.
Q: What do you like to do in your free time?
Dr. Ketover: I like to run, bike, walk. I like being outside as much as possible and enjoy being active.
Lightning Round
Texting or talking?
Texting, very efficient
Favorite city in U.S. besides the one you live in?
Waikiki, Honolulu
Favorite breakfast?
Pancakes
Place you most want to travel to?
Australia and New Zealand
Favorite junk food?
Pretzels and ice cream
Favorite season?
Summer
How many cups of coffee do you drink per day?
2-3
If you weren’t a gastroenterologist, what would you be?
Public policy writer
Who inspires you?
My wife
Best Halloween costume you ever wore?
Cowboy
Favorite type of music?
Classic rock
Favorite movie genre?
Science fiction, space exploration
Cat person or dog person?
Dog
Favorite sport?
Football — to watch
What song do you have to sing along with when you hear it?
Bohemian Rhapsody
Introvert or extrovert?
Introvert
Optimist or pessimist?
Optimist
What exactly is a healthy diet?
Scott Ketover, MD, AGAF, FASGE, will be the first to admit that’s not an easy question to answer. “As much research and information as we have, we don’t really know what a healthy diet is,” said Dr. Ketover, president and CEO of MNGI Digestive Health in Minneapolis, Minnesota. He was recognized by AGA this year with the Distinguished Clinician Award in Private Practice.
When patients ask questions about a healthy diet, Dr. Ketover responds with a dose of common sense: “If it’s food that didn’t exist in the year 1900, don’t eat it.” Your grandmother’s apple pie is fine in moderation, he said, but the apple pie you get at the McDonald’s drive-through could sit on your shelf for 6 months and look the same.
That is not something you should eat, he emphasizes.
“I really do believe though, that what crosses our lips and gets into our GI tract really underlies our entire health. It’s just that we don’t have enough information yet to know how we can coach people in telling them: eat this, not that,” he added.
In an interview, Dr. Ketover spoke more about the link between the gut microbiome and health, and the young patient who inspired him to become a GI physician.
Q: Why did you choose GI?
Dr. Ketover: I was a medical student working on my pediatrics rotation at Children’s Minnesota (Minneapolis Pediatrics Hospital). A 17-year-old young man who had Crohn’s disease really turned this into my lifelong passion. The patient confided in me that when he was 11, he had an ileostomy. He wore an ileostomy bag for 6 years and kept it hidden from all his friends. He was petrified of their knowing. And he told me at the age of 17 that if he knew how hard it was going to be to keep that secret, he would’ve preferred to have died rather than have the ileostomy. That got me thinking a lot about Crohn’s disease, and certainly how it affects patients. It became a very motivating thing for me to be involved in something that could potentially prevent this situation for others.
Today, we have much better treatment for Crohn’s than we did 30 years ago. So that’s all a good thing.
Q: Wellness and therapeutic diets are a specific interest of yours. Can you talk about this?
Dr. Ketover: We talk about things like Cheetos, Twinkies — those are not real foods. I do direct patients to ‘think’ when they go to the grocery store. All the good stuff is in the perimeter of the store. When you walk down the aisles, it’s all the processed food with added chemicals. It’s hard to point at specific things though and say: this is bad for you, but we do know that we should eat real food as often as we can. And I think that will contribute to our knowledge and learning about the intestinal microbiome. Again, we’re really at the beginning of our infancy of this, even though there’s lots of probiotics and things out there that claim to make you healthier. We don’t really know yet. And it’s going to take more time.
Q: What role does diet play in improving the intestinal microbiome?
Dr. Ketover: When you look at people who are healthy and who have low incidence of chronic diseases or inflammatory conditions, obesity, cancer, we’re starting to study their microbiome to see how it differs from people who have those illnesses and conditions and try to understand what the different constituents are of the microbiome. And then the big question is: Okay, so once we know that, how do we take ‘the unhealthy microbiome’ and change it to the ‘healthy microbiome’?
The only method we currently have is fecal transplant for Clostridioides difficile. And that’s just not a feasible way to change the microbiome for most people.
Some studies are going on with this. There’s been laboratory studies done with lab animals that show that fecal transplant can reverse obesity.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Ketover: The biggest challenge these days for medical practices is the relationship with the payer world and prior authorization. Where we’ve seen the greatest impact of prior authorization, unfortunately, is in the Medicare Advantage programs. Payers receive money from the federal government on plans that they can better manage the patient on, rather than Medicare. That results in a tremendous amount of prior authorization.
I get particularly incensed when I see that a lot of payers are practicing medicine without a license and they’re not relying on the professionals who are actually in the exam room with patients and doing the history and physical examination to determine what is an appropriate course of diagnosis or therapy for a patient.
It comes around every January. We have patients who are stable on meds, then their insurance gets renewed and the pharmacy formulary changes. Patients stable on various therapies are either kicked off them, or we have to go through the prior authorization process again for the same patient for the umpteenth time to keep them on a stable therapy.
How do I address that? It’s in conversations with payers and policy makers. There’s a lot going on in Washington, talking about prior authorization. I’m not sure that non-practitioners fully feel the pain that it delivers to patients.
Q: What teacher or mentor had the greatest impact on you?
Dr. Ketover: Phillip M. Kibort, MD, the pediatric physician I worked with as a medical student who really turned me on to GI medicine. We worked together on several patients and I was able to develop an appreciation for the breadth and depth of GI-related abnormalities and diseases and therapies. And I really got excited by the spectrum of opportunity that I would have as a physician to help treat patients with GI illness.
Q: What would you do differently if you had a chance?
Dr. Ketover: I’d travel more both for work and for pleasure. I really enjoy my relationships that I’ve created with lots of other gastroenterologists as well as non-physicians around policy issues. I’m involved in a couple of national organizations that talk to politicians on Capitol Hill and at state houses about patient advocacy. I would have done more of that earlier in my career if I could have.
Q: What do you like to do in your free time?
Dr. Ketover: I like to run, bike, walk. I like being outside as much as possible and enjoy being active.
Lightning Round
Texting or talking?
Texting, very efficient
Favorite city in U.S. besides the one you live in?
Waikiki, Honolulu
Favorite breakfast?
Pancakes
Place you most want to travel to?
Australia and New Zealand
Favorite junk food?
Pretzels and ice cream
Favorite season?
Summer
How many cups of coffee do you drink per day?
2-3
If you weren’t a gastroenterologist, what would you be?
Public policy writer
Who inspires you?
My wife
Best Halloween costume you ever wore?
Cowboy
Favorite type of music?
Classic rock
Favorite movie genre?
Science fiction, space exploration
Cat person or dog person?
Dog
Favorite sport?
Football — to watch
What song do you have to sing along with when you hear it?
Bohemian Rhapsody
Introvert or extrovert?
Introvert
Optimist or pessimist?
Optimist
What exactly is a healthy diet?
Scott Ketover, MD, AGAF, FASGE, will be the first to admit that’s not an easy question to answer. “As much research and information as we have, we don’t really know what a healthy diet is,” said Dr. Ketover, president and CEO of MNGI Digestive Health in Minneapolis, Minnesota. He was recognized by AGA this year with the Distinguished Clinician Award in Private Practice.
When patients ask questions about a healthy diet, Dr. Ketover responds with a dose of common sense: “If it’s food that didn’t exist in the year 1900, don’t eat it.” Your grandmother’s apple pie is fine in moderation, he said, but the apple pie you get at the McDonald’s drive-through could sit on your shelf for 6 months and look the same.
That is not something you should eat, he emphasizes.
“I really do believe though, that what crosses our lips and gets into our GI tract really underlies our entire health. It’s just that we don’t have enough information yet to know how we can coach people in telling them: eat this, not that,” he added.
In an interview, Dr. Ketover spoke more about the link between the gut microbiome and health, and the young patient who inspired him to become a GI physician.
Q: Why did you choose GI?
Dr. Ketover: I was a medical student working on my pediatrics rotation at Children’s Minnesota (Minneapolis Pediatrics Hospital). A 17-year-old young man who had Crohn’s disease really turned this into my lifelong passion. The patient confided in me that when he was 11, he had an ileostomy. He wore an ileostomy bag for 6 years and kept it hidden from all his friends. He was petrified of their knowing. And he told me at the age of 17 that if he knew how hard it was going to be to keep that secret, he would’ve preferred to have died rather than have the ileostomy. That got me thinking a lot about Crohn’s disease, and certainly how it affects patients. It became a very motivating thing for me to be involved in something that could potentially prevent this situation for others.
Today, we have much better treatment for Crohn’s than we did 30 years ago. So that’s all a good thing.
Q: Wellness and therapeutic diets are a specific interest of yours. Can you talk about this?
Dr. Ketover: We talk about things like Cheetos, Twinkies — those are not real foods. I do direct patients to ‘think’ when they go to the grocery store. All the good stuff is in the perimeter of the store. When you walk down the aisles, it’s all the processed food with added chemicals. It’s hard to point at specific things though and say: this is bad for you, but we do know that we should eat real food as often as we can. And I think that will contribute to our knowledge and learning about the intestinal microbiome. Again, we’re really at the beginning of our infancy of this, even though there’s lots of probiotics and things out there that claim to make you healthier. We don’t really know yet. And it’s going to take more time.
Q: What role does diet play in improving the intestinal microbiome?
Dr. Ketover: When you look at people who are healthy and who have low incidence of chronic diseases or inflammatory conditions, obesity, cancer, we’re starting to study their microbiome to see how it differs from people who have those illnesses and conditions and try to understand what the different constituents are of the microbiome. And then the big question is: Okay, so once we know that, how do we take ‘the unhealthy microbiome’ and change it to the ‘healthy microbiome’?
The only method we currently have is fecal transplant for Clostridioides difficile. And that’s just not a feasible way to change the microbiome for most people.
Some studies are going on with this. There’s been laboratory studies done with lab animals that show that fecal transplant can reverse obesity.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Ketover: The biggest challenge these days for medical practices is the relationship with the payer world and prior authorization. Where we’ve seen the greatest impact of prior authorization, unfortunately, is in the Medicare Advantage programs. Payers receive money from the federal government on plans that they can better manage the patient on, rather than Medicare. That results in a tremendous amount of prior authorization.
I get particularly incensed when I see that a lot of payers are practicing medicine without a license and they’re not relying on the professionals who are actually in the exam room with patients and doing the history and physical examination to determine what is an appropriate course of diagnosis or therapy for a patient.
It comes around every January. We have patients who are stable on meds, then their insurance gets renewed and the pharmacy formulary changes. Patients stable on various therapies are either kicked off them, or we have to go through the prior authorization process again for the same patient for the umpteenth time to keep them on a stable therapy.
How do I address that? It’s in conversations with payers and policy makers. There’s a lot going on in Washington, talking about prior authorization. I’m not sure that non-practitioners fully feel the pain that it delivers to patients.
Q: What teacher or mentor had the greatest impact on you?
Dr. Ketover: Phillip M. Kibort, MD, the pediatric physician I worked with as a medical student who really turned me on to GI medicine. We worked together on several patients and I was able to develop an appreciation for the breadth and depth of GI-related abnormalities and diseases and therapies. And I really got excited by the spectrum of opportunity that I would have as a physician to help treat patients with GI illness.
Q: What would you do differently if you had a chance?
Dr. Ketover: I’d travel more both for work and for pleasure. I really enjoy my relationships that I’ve created with lots of other gastroenterologists as well as non-physicians around policy issues. I’m involved in a couple of national organizations that talk to politicians on Capitol Hill and at state houses about patient advocacy. I would have done more of that earlier in my career if I could have.
Q: What do you like to do in your free time?
Dr. Ketover: I like to run, bike, walk. I like being outside as much as possible and enjoy being active.
Lightning Round
Texting or talking?
Texting, very efficient
Favorite city in U.S. besides the one you live in?
Waikiki, Honolulu
Favorite breakfast?
Pancakes
Place you most want to travel to?
Australia and New Zealand
Favorite junk food?
Pretzels and ice cream
Favorite season?
Summer
How many cups of coffee do you drink per day?
2-3
If you weren’t a gastroenterologist, what would you be?
Public policy writer
Who inspires you?
My wife
Best Halloween costume you ever wore?
Cowboy
Favorite type of music?
Classic rock
Favorite movie genre?
Science fiction, space exploration
Cat person or dog person?
Dog
Favorite sport?
Football — to watch
What song do you have to sing along with when you hear it?
Bohemian Rhapsody
Introvert or extrovert?
Introvert
Optimist or pessimist?
Optimist
Introducing your 2024 AGA recognition prize recipients
We are proud to announce the 2024 recipients of our annual recognition prizes, given in honor of outstanding contributions and achievements in gastroenterology and hepatology.
Congratulations to Bishr Omary, MD, PhD, for receiving AGA’s highest honor, the Julius Friedenwald Medal.
Presented annually since 1941, this award recognizes a physician for lifelong contributions to the field of gastroenterology.
2024 recognition prize recipients:
- Julius Friedenwald Medal: Bishr Omary, MD, PhD
- William Beaumont Prize: Hashem B. El-Serag, MD, MPH
- Distinguished Achievement Award in Basic Science: Jerrold R. Turner, MD, PhD, AGAF
- Distinguished Service Award in Diversity, Equity, and Inclusion: Sophie Balzora, MD
- Distinguished Clinician Award in Private Practice: Scott Ketover, MD, AGAF, FASGE
- Distinguished Clinician Award in Academic Practice: Shiv Kumar Sarin, MD
- Distinguished Educator Award: David Katzka, MD, AGAF
- Distinguished Mentor Award: John Pandolfino, MD
- Young Investigator Award in Clinical Science: Mingyang Song, ScD
We are proud to announce the 2024 recipients of our annual recognition prizes, given in honor of outstanding contributions and achievements in gastroenterology and hepatology.
Congratulations to Bishr Omary, MD, PhD, for receiving AGA’s highest honor, the Julius Friedenwald Medal.
Presented annually since 1941, this award recognizes a physician for lifelong contributions to the field of gastroenterology.
2024 recognition prize recipients:
- Julius Friedenwald Medal: Bishr Omary, MD, PhD
- William Beaumont Prize: Hashem B. El-Serag, MD, MPH
- Distinguished Achievement Award in Basic Science: Jerrold R. Turner, MD, PhD, AGAF
- Distinguished Service Award in Diversity, Equity, and Inclusion: Sophie Balzora, MD
- Distinguished Clinician Award in Private Practice: Scott Ketover, MD, AGAF, FASGE
- Distinguished Clinician Award in Academic Practice: Shiv Kumar Sarin, MD
- Distinguished Educator Award: David Katzka, MD, AGAF
- Distinguished Mentor Award: John Pandolfino, MD
- Young Investigator Award in Clinical Science: Mingyang Song, ScD
We are proud to announce the 2024 recipients of our annual recognition prizes, given in honor of outstanding contributions and achievements in gastroenterology and hepatology.
Congratulations to Bishr Omary, MD, PhD, for receiving AGA’s highest honor, the Julius Friedenwald Medal.
Presented annually since 1941, this award recognizes a physician for lifelong contributions to the field of gastroenterology.
2024 recognition prize recipients:
- Julius Friedenwald Medal: Bishr Omary, MD, PhD
- William Beaumont Prize: Hashem B. El-Serag, MD, MPH
- Distinguished Achievement Award in Basic Science: Jerrold R. Turner, MD, PhD, AGAF
- Distinguished Service Award in Diversity, Equity, and Inclusion: Sophie Balzora, MD
- Distinguished Clinician Award in Private Practice: Scott Ketover, MD, AGAF, FASGE
- Distinguished Clinician Award in Academic Practice: Shiv Kumar Sarin, MD
- Distinguished Educator Award: David Katzka, MD, AGAF
- Distinguished Mentor Award: John Pandolfino, MD
- Young Investigator Award in Clinical Science: Mingyang Song, ScD
AI Wins AGA’s Shark Tank Competition
CHICAGO — At the 2024 AGA Tech Summit, held April 11-12 at the Chicago headquarters of MATTER, a global healthcare startup incubator, five companies made their pitch to be the winner of the Shark Tank competition that recognizes an outstanding tech start up in the gastroenterology field.
After the companies’ rapid-fire pitches and Q&A sessions, four judges convened to determine a winner and returned to make an announcement.
The winner was Arithmedics, which uses AI technology to automate billing codes. Founder Venthan Elango, PhD, has worked as a software engineer at Google, Urban Engines, and Georgia Tech, and his wife of 17 years is Renumathy Dhanasekaran, MD, PhD, a gastroenterologist and assistant professor of medicine at Stanford (California) University.
Their marriage has brought a unique perspective, according to Dr. Elango. “There isn’t a single day that goes by when she talks to me about the inefficiencies in healthcare, and then I say, ‘this can be easily solved with a software solution,’ ” he said.
When they decided to try a start-up, the two initiated conversations with healthcare providers to identify a key unmet need. “The common recurring theme was that medical billing was a problem, because of [insufficient] institutional knowledge, staff shortage, and inconsistencies with the payers,” said Dr. Elango. During their presentation, the two noted that about 80% of claims include at least one coding error, and this leads to an estimated $125 billion in annual losses.
Generative AI presented a solution. “Automating the medical billing code [determination] from a clinical record became 10 times easier than what it was before. So I thought, I can build a product that actually brings in augmented analytics and generative AI and do something that is tremendously useful to physicians,” he said.
The future goal is to make life easier for healthcare providers, according to Dr. Dhanasekaran. “As physicians, we went into medicine to talk with patients, but a lot of us are just typing away when patients are sitting in the room, because there are all of these requirements for documentation to get the billing so that we can get paid at the end of the day,” she said.
Arithmedics aims to initially target small-group medical practices that are tech savvy. They will analyze a year’s worth of claims for errors and resubmit claims for the past 3 months and split any additional revenue that ensues. They plan to expand to revenue cycle management companies and hospital systems. On the technology side, they will expand to data intelligence and integrate with electronic health records, and ultimately plan to charge 1%-2% of revenue.
The other Shark Tank finalists were:
- Aspero Medical: Balloon overtube that maximizes frictional properties to improve mucosal wall traction and anchoring consistency. (Voted ‘fan favorite’ by AGA Tech Summit attendees)
- Aurora Medical Technologies: Minimally invasive, guided, tissue-anchoring suturing system for complex endoscopic procedures.
- Ergami Endoscopy: Flexible overtube capable of automatic insertion and fixation in the colon, which could potentially eliminate sedation and prevent endoscopic injuries to the physician.
- Lazurite: Wireless surgical camera that eliminates the need for light or video cables, avoiding the associated fire, trip, and contamination hazards.
The judges were swayed by Arithmedics’ practical solution to a widespread problem. “There is for sure a need in terms of inaccurate billing and billing codes that are wrong. There’s lost revenue for physicians around that. So I think we were really focused from a judging standpoint on the fact that their solution was filling truly an unmet need,” said judge Andrea Vossler, a managing director of Varia Ventures, which has partnered with AGA to launch and manage the GI Opportunity Fund, an AGA-member venture fund.
“We were really focused on how to assist physicians in terms of supporting their practices, and really changing what you’re doing. I think AI has the ability to do that, so we liked that about the company,” she added.
The company is an example of how AI is poised to alter healthcare, according to Ms. Vossler. “I think it’s massive. I think we’re at the very beginning of its impact on healthcare,” she said.
Another judge had a similar view. “They won because there is a screaming need to fix billing. So, it’s well known that lots of money is indeed lost in billing practices, which are stressful for office personnel and stressful for physicians. They can fulfill a long-standing need, and we thought that that was the success story,” said Christopher Gostout, MD, emeritus professor of medicine at Mayo Clinic in Rochester, Minnesota.
Dr. Gostout offered advice for gastroenterologists and other physicians interested in starting tech companies. It’s imperative to be a realist, he said. “Is there a real market for it, or [is it just] a niche market? Does your device have legs — can it expand and can evolve into other [spin-off] products? These are things you need to think about because one-offs or single-trick ponies are pretty hard to move along now,” said Dr. Gostout.
He recommended that entrepreneurs apply for Small Business Innovation Research (SBIR) grants. “I think it’s a great opportunity to bring in money and get the ball rolling.”
Finally, he advised entrepreneurs to be thoughtful about their advisory groups. Founders may be tempted to find the highest profile names they can to give the business gravitas, but those big names may not have the best knowledge base to understand the problems that the technology is meant to address. “I’ve seen businesses fail because they went for marquee names that really were not helpful, and they didn’t do their due diligence in seeking out really useful value. You don’t need a lot of advisers, just a couple of really good ones,” said Dr. Gostout.
The summit was sponsored by the AGA Center for GI Innovation and Technology.
Dr. Gostout has founded and advises AdaptivEndo and Lean Medical. He is a consultant to Boston Scientific. Dr. Dhanasekaran has no financial disclosures. Ms. Vossler is an employee of Varia Ventures, which is an investment partner to AGA. Dr. Elango is an employee of Arithmedics.
CHICAGO — At the 2024 AGA Tech Summit, held April 11-12 at the Chicago headquarters of MATTER, a global healthcare startup incubator, five companies made their pitch to be the winner of the Shark Tank competition that recognizes an outstanding tech start up in the gastroenterology field.
After the companies’ rapid-fire pitches and Q&A sessions, four judges convened to determine a winner and returned to make an announcement.
The winner was Arithmedics, which uses AI technology to automate billing codes. Founder Venthan Elango, PhD, has worked as a software engineer at Google, Urban Engines, and Georgia Tech, and his wife of 17 years is Renumathy Dhanasekaran, MD, PhD, a gastroenterologist and assistant professor of medicine at Stanford (California) University.
Their marriage has brought a unique perspective, according to Dr. Elango. “There isn’t a single day that goes by when she talks to me about the inefficiencies in healthcare, and then I say, ‘this can be easily solved with a software solution,’ ” he said.
When they decided to try a start-up, the two initiated conversations with healthcare providers to identify a key unmet need. “The common recurring theme was that medical billing was a problem, because of [insufficient] institutional knowledge, staff shortage, and inconsistencies with the payers,” said Dr. Elango. During their presentation, the two noted that about 80% of claims include at least one coding error, and this leads to an estimated $125 billion in annual losses.
Generative AI presented a solution. “Automating the medical billing code [determination] from a clinical record became 10 times easier than what it was before. So I thought, I can build a product that actually brings in augmented analytics and generative AI and do something that is tremendously useful to physicians,” he said.
The future goal is to make life easier for healthcare providers, according to Dr. Dhanasekaran. “As physicians, we went into medicine to talk with patients, but a lot of us are just typing away when patients are sitting in the room, because there are all of these requirements for documentation to get the billing so that we can get paid at the end of the day,” she said.
Arithmedics aims to initially target small-group medical practices that are tech savvy. They will analyze a year’s worth of claims for errors and resubmit claims for the past 3 months and split any additional revenue that ensues. They plan to expand to revenue cycle management companies and hospital systems. On the technology side, they will expand to data intelligence and integrate with electronic health records, and ultimately plan to charge 1%-2% of revenue.
The other Shark Tank finalists were:
- Aspero Medical: Balloon overtube that maximizes frictional properties to improve mucosal wall traction and anchoring consistency. (Voted ‘fan favorite’ by AGA Tech Summit attendees)
- Aurora Medical Technologies: Minimally invasive, guided, tissue-anchoring suturing system for complex endoscopic procedures.
- Ergami Endoscopy: Flexible overtube capable of automatic insertion and fixation in the colon, which could potentially eliminate sedation and prevent endoscopic injuries to the physician.
- Lazurite: Wireless surgical camera that eliminates the need for light or video cables, avoiding the associated fire, trip, and contamination hazards.
The judges were swayed by Arithmedics’ practical solution to a widespread problem. “There is for sure a need in terms of inaccurate billing and billing codes that are wrong. There’s lost revenue for physicians around that. So I think we were really focused from a judging standpoint on the fact that their solution was filling truly an unmet need,” said judge Andrea Vossler, a managing director of Varia Ventures, which has partnered with AGA to launch and manage the GI Opportunity Fund, an AGA-member venture fund.
“We were really focused on how to assist physicians in terms of supporting their practices, and really changing what you’re doing. I think AI has the ability to do that, so we liked that about the company,” she added.
The company is an example of how AI is poised to alter healthcare, according to Ms. Vossler. “I think it’s massive. I think we’re at the very beginning of its impact on healthcare,” she said.
Another judge had a similar view. “They won because there is a screaming need to fix billing. So, it’s well known that lots of money is indeed lost in billing practices, which are stressful for office personnel and stressful for physicians. They can fulfill a long-standing need, and we thought that that was the success story,” said Christopher Gostout, MD, emeritus professor of medicine at Mayo Clinic in Rochester, Minnesota.
Dr. Gostout offered advice for gastroenterologists and other physicians interested in starting tech companies. It’s imperative to be a realist, he said. “Is there a real market for it, or [is it just] a niche market? Does your device have legs — can it expand and can evolve into other [spin-off] products? These are things you need to think about because one-offs or single-trick ponies are pretty hard to move along now,” said Dr. Gostout.
He recommended that entrepreneurs apply for Small Business Innovation Research (SBIR) grants. “I think it’s a great opportunity to bring in money and get the ball rolling.”
Finally, he advised entrepreneurs to be thoughtful about their advisory groups. Founders may be tempted to find the highest profile names they can to give the business gravitas, but those big names may not have the best knowledge base to understand the problems that the technology is meant to address. “I’ve seen businesses fail because they went for marquee names that really were not helpful, and they didn’t do their due diligence in seeking out really useful value. You don’t need a lot of advisers, just a couple of really good ones,” said Dr. Gostout.
The summit was sponsored by the AGA Center for GI Innovation and Technology.
Dr. Gostout has founded and advises AdaptivEndo and Lean Medical. He is a consultant to Boston Scientific. Dr. Dhanasekaran has no financial disclosures. Ms. Vossler is an employee of Varia Ventures, which is an investment partner to AGA. Dr. Elango is an employee of Arithmedics.
CHICAGO — At the 2024 AGA Tech Summit, held April 11-12 at the Chicago headquarters of MATTER, a global healthcare startup incubator, five companies made their pitch to be the winner of the Shark Tank competition that recognizes an outstanding tech start up in the gastroenterology field.
After the companies’ rapid-fire pitches and Q&A sessions, four judges convened to determine a winner and returned to make an announcement.
The winner was Arithmedics, which uses AI technology to automate billing codes. Founder Venthan Elango, PhD, has worked as a software engineer at Google, Urban Engines, and Georgia Tech, and his wife of 17 years is Renumathy Dhanasekaran, MD, PhD, a gastroenterologist and assistant professor of medicine at Stanford (California) University.
Their marriage has brought a unique perspective, according to Dr. Elango. “There isn’t a single day that goes by when she talks to me about the inefficiencies in healthcare, and then I say, ‘this can be easily solved with a software solution,’ ” he said.
When they decided to try a start-up, the two initiated conversations with healthcare providers to identify a key unmet need. “The common recurring theme was that medical billing was a problem, because of [insufficient] institutional knowledge, staff shortage, and inconsistencies with the payers,” said Dr. Elango. During their presentation, the two noted that about 80% of claims include at least one coding error, and this leads to an estimated $125 billion in annual losses.
Generative AI presented a solution. “Automating the medical billing code [determination] from a clinical record became 10 times easier than what it was before. So I thought, I can build a product that actually brings in augmented analytics and generative AI and do something that is tremendously useful to physicians,” he said.
The future goal is to make life easier for healthcare providers, according to Dr. Dhanasekaran. “As physicians, we went into medicine to talk with patients, but a lot of us are just typing away when patients are sitting in the room, because there are all of these requirements for documentation to get the billing so that we can get paid at the end of the day,” she said.
Arithmedics aims to initially target small-group medical practices that are tech savvy. They will analyze a year’s worth of claims for errors and resubmit claims for the past 3 months and split any additional revenue that ensues. They plan to expand to revenue cycle management companies and hospital systems. On the technology side, they will expand to data intelligence and integrate with electronic health records, and ultimately plan to charge 1%-2% of revenue.
The other Shark Tank finalists were:
- Aspero Medical: Balloon overtube that maximizes frictional properties to improve mucosal wall traction and anchoring consistency. (Voted ‘fan favorite’ by AGA Tech Summit attendees)
- Aurora Medical Technologies: Minimally invasive, guided, tissue-anchoring suturing system for complex endoscopic procedures.
- Ergami Endoscopy: Flexible overtube capable of automatic insertion and fixation in the colon, which could potentially eliminate sedation and prevent endoscopic injuries to the physician.
- Lazurite: Wireless surgical camera that eliminates the need for light or video cables, avoiding the associated fire, trip, and contamination hazards.
The judges were swayed by Arithmedics’ practical solution to a widespread problem. “There is for sure a need in terms of inaccurate billing and billing codes that are wrong. There’s lost revenue for physicians around that. So I think we were really focused from a judging standpoint on the fact that their solution was filling truly an unmet need,” said judge Andrea Vossler, a managing director of Varia Ventures, which has partnered with AGA to launch and manage the GI Opportunity Fund, an AGA-member venture fund.
“We were really focused on how to assist physicians in terms of supporting their practices, and really changing what you’re doing. I think AI has the ability to do that, so we liked that about the company,” she added.
The company is an example of how AI is poised to alter healthcare, according to Ms. Vossler. “I think it’s massive. I think we’re at the very beginning of its impact on healthcare,” she said.
Another judge had a similar view. “They won because there is a screaming need to fix billing. So, it’s well known that lots of money is indeed lost in billing practices, which are stressful for office personnel and stressful for physicians. They can fulfill a long-standing need, and we thought that that was the success story,” said Christopher Gostout, MD, emeritus professor of medicine at Mayo Clinic in Rochester, Minnesota.
Dr. Gostout offered advice for gastroenterologists and other physicians interested in starting tech companies. It’s imperative to be a realist, he said. “Is there a real market for it, or [is it just] a niche market? Does your device have legs — can it expand and can evolve into other [spin-off] products? These are things you need to think about because one-offs or single-trick ponies are pretty hard to move along now,” said Dr. Gostout.
He recommended that entrepreneurs apply for Small Business Innovation Research (SBIR) grants. “I think it’s a great opportunity to bring in money and get the ball rolling.”
Finally, he advised entrepreneurs to be thoughtful about their advisory groups. Founders may be tempted to find the highest profile names they can to give the business gravitas, but those big names may not have the best knowledge base to understand the problems that the technology is meant to address. “I’ve seen businesses fail because they went for marquee names that really were not helpful, and they didn’t do their due diligence in seeking out really useful value. You don’t need a lot of advisers, just a couple of really good ones,” said Dr. Gostout.
The summit was sponsored by the AGA Center for GI Innovation and Technology.
Dr. Gostout has founded and advises AdaptivEndo and Lean Medical. He is a consultant to Boston Scientific. Dr. Dhanasekaran has no financial disclosures. Ms. Vossler is an employee of Varia Ventures, which is an investment partner to AGA. Dr. Elango is an employee of Arithmedics.
FROM THE 2024 AGA TECH SUMMIT
Investing in the Future of GI
Talented young investigators are walking away from gastroenterology and hepatology research frustrated by a lack of support. For the last decades, Congress has slashed research funding and even greater cuts are on the horizon. Investigators in the early stages of their careers are particularly hard hit. Without help from other funding sources, young investigators struggle to continue their research, build their research portfolio, and obtain federal funding.
Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the gastroenterology and hepatology fields — clinicians and researchers alike — have benefited from the discoveries of dedicated investigators, past and present.
Right now, creative young researchers are poised to make groundbreaking discoveries that will shape the future of gastroenterology and hepatology. Unfortunately, declining government funding for biomedical research puts this potential in jeopardy. We’re at risk of losing an entire generation of researchers.
To fill this gap, the AGA Research Foundation invites you to support its mission by making a donation. Funds raised through the AGA Research Foundation will support the pipeline of new investigators’ research careers, allowing them to make discoveries that could ultimately improve patient care and even cure diseases.
“I donated to the AGA Research Foundation to ensure the vitality of our specialty, and to fund the research of future generations of gastroenterologists. Funding from organizations like the AGA Research Foundation is crucial for young scientists and gastroenterologists to launch their careers,” states Michael Camilleri, MD, AGAF, AGA Research Foundation Chair.
By joining others in supporting the AGA Research Foundation, you will ensure that young researchers have opportunities to continue their life-saving work. Learn more or make a contribution at www.foundation.gastro.org.
Talented young investigators are walking away from gastroenterology and hepatology research frustrated by a lack of support. For the last decades, Congress has slashed research funding and even greater cuts are on the horizon. Investigators in the early stages of their careers are particularly hard hit. Without help from other funding sources, young investigators struggle to continue their research, build their research portfolio, and obtain federal funding.
Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the gastroenterology and hepatology fields — clinicians and researchers alike — have benefited from the discoveries of dedicated investigators, past and present.
Right now, creative young researchers are poised to make groundbreaking discoveries that will shape the future of gastroenterology and hepatology. Unfortunately, declining government funding for biomedical research puts this potential in jeopardy. We’re at risk of losing an entire generation of researchers.
To fill this gap, the AGA Research Foundation invites you to support its mission by making a donation. Funds raised through the AGA Research Foundation will support the pipeline of new investigators’ research careers, allowing them to make discoveries that could ultimately improve patient care and even cure diseases.
“I donated to the AGA Research Foundation to ensure the vitality of our specialty, and to fund the research of future generations of gastroenterologists. Funding from organizations like the AGA Research Foundation is crucial for young scientists and gastroenterologists to launch their careers,” states Michael Camilleri, MD, AGAF, AGA Research Foundation Chair.
By joining others in supporting the AGA Research Foundation, you will ensure that young researchers have opportunities to continue their life-saving work. Learn more or make a contribution at www.foundation.gastro.org.
Talented young investigators are walking away from gastroenterology and hepatology research frustrated by a lack of support. For the last decades, Congress has slashed research funding and even greater cuts are on the horizon. Investigators in the early stages of their careers are particularly hard hit. Without help from other funding sources, young investigators struggle to continue their research, build their research portfolio, and obtain federal funding.
Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the gastroenterology and hepatology fields — clinicians and researchers alike — have benefited from the discoveries of dedicated investigators, past and present.
Right now, creative young researchers are poised to make groundbreaking discoveries that will shape the future of gastroenterology and hepatology. Unfortunately, declining government funding for biomedical research puts this potential in jeopardy. We’re at risk of losing an entire generation of researchers.
To fill this gap, the AGA Research Foundation invites you to support its mission by making a donation. Funds raised through the AGA Research Foundation will support the pipeline of new investigators’ research careers, allowing them to make discoveries that could ultimately improve patient care and even cure diseases.
“I donated to the AGA Research Foundation to ensure the vitality of our specialty, and to fund the research of future generations of gastroenterologists. Funding from organizations like the AGA Research Foundation is crucial for young scientists and gastroenterologists to launch their careers,” states Michael Camilleri, MD, AGAF, AGA Research Foundation Chair.
By joining others in supporting the AGA Research Foundation, you will ensure that young researchers have opportunities to continue their life-saving work. Learn more or make a contribution at www.foundation.gastro.org.