Why Every Hospital Should (Must) Have an ACE Unit by 2040

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Like the rest of the world, the United States is experiencing an aging boom. The number of adults aged 65 years or older is expected to grow from 49 million in 2016 to 82 million in 2040, indicating an increase of 67%. Even more impressively, the population of individuals aged 85 years or older is expected to increase by 129% to 14.6 million within this same time period.1 Considering that one in five Medicare Fee for Service beneficiaries are hospitalized at least once a year,2 hospitals can expect the number of adults over the age of 65 requiring acute care will substantially increase over the next 20 years. These demographic changes have important implications for the overall healthcare costs in the US. Of persons with the highest annual healthcare expenditures, 40% are 65 years of age or older. 3 Thus, optimizing the care of hospitalized older adults will remain a critical component in the management of healthcare costs in the next 20 years.

As such, the Acute Care for the Elderly (ACE) unit, an interprofessional model of care that has been shown to provide high-quality care to hospitalized older adults without increasing costs,4 will become an increasingly important component of acute care as the older adult population grows. In this edition of the Journal of Hospital Medicine, Brennan et al.5 describe a quality improvement initiative in which an interprofessional team that included a geriatric clinician, nurses, pharmacist, and chaplain developed a daily plan of care for ACE unit patients aged 70 years or older. The daily care plan, which focused on symptom management and advance care planning, was the nidus for collaboration between the hospital medicine attending and geriatrics team. Their results demonstrate that ACE unit patients had lower hospital costs and shorter lengths of stay (LOS) as compared with age-matched, usual-care patients despite having higher comorbidity scores. In addition, the greatest benefits were seen among persons in the highest quartile of the comorbidity score.

These results add to the small but consistent body of literature that demonstrates quality and cost benefits to the ACE unit care. Importantly, however, in contrast with the prior ACE unit studies in which persons with moderate risk were the ones to demonstrate the greatest benefits, Brennan et al.5 were able to demonstrate the greatest effect for the highest-need, highest-cost population. Reasons for this impressive effect may be attributed to this intervention’s specific emphasis on symptom management and estimated life expectancy. In an era when Medicare and other payers are looking to increase the value proposition in population health-based approaches by reducing high costs while preserving high quality, these findings represent an important example that merits a broader dissemination.

Of course, ACE units are not the only hospital-based programs that have shown to improve outcomes for older adults. The Hospital Elder Life Program (HELP) is an evidence-based delirium prevention intervention that has been shown to not only prevent delirium but also prevent cognitive and functional decline while decreasing hospital LOS, hospital falls, and sitter use.6 Moreover, similar to ACE units, HELP has been shown to reduce inhospital patient costs. Geriatrics surgery comanagement programs are another hospital-based intervention that has shown to improve outcomes for older surgical patients. Reductions in LOS, improved mobility, and higher discharge to home have been demonstrated in patients who have undergone spinal surgery.7 Decreased LOS and lower hospital costs have also been demonstrated among patients with hip fracture undergoing repair.8 Programs such as ACE units, HELP, and geriatric surgery comanagement are well aligned with the growing emphasis on value-based healthcare and will be especially needed by hospitals that strive to be high-reliability organizations as the number of adults aged 65 and older continues to grow. To date, few studies have explored the potential synergistic effects (or redundancies) of these programs and how to maximize the impact of these evidence-based interventions across healthcare systems with multiple hospitals that care for older adults from various socioeconomic and cultural backgrounds.

Looking toward the future, the implementation of ACE units and other innovative geriatric programs will equip hospitals to develop into Age-Friendly Health Systems (AFHS). AFHS is an initiative being led by the Institute for Healthcare Improvement, The John A. Hartford Foundation, the American Hospital Association, and the Catholic Health Association of the United States in partnership with several other leading healthcare organizations to provide high-value care to every older adult.9 AFHS provide care focused on the 4M framework—What Matters, Medications, Mobility, and Mentation. The goal is for 20% of hospitals and medical practices to join the AFHS initiative by 2020; to date, over 70 organizations nationwide have done so. Clearly, to reach this goal, and beyond, a greater collaboration between aging-focused interprofessional teams including geriatricians and hospitalists will be essential.

Given the aging demographic and rising healthcare costs, Brennan et al.’s work5 suggests that each hospital should have an ACE unit by 2040. Consistently, hospital care delivery has appropriately developed in response to the needs of the patient population served. Intensive care units (ICUs), dialysis units, and emergency rooms are just a few innovations that were adopted by hospitals to provide specialty care to individuals with complex acute illnesses. While technology within the ICU certainly plays a role in the care delivered in that setting, it could be argued that what makes the ICUs most effective is the cohorting of interprofessional expertise. Since the implementation of ICUs, the survival rate for critically ill patients has substantially improved and additional specialty units with an interprofessional team model, eg, cardiac care units, dialysis units, emergency rooms, etc., have followed suit. Specialty units have become a part of the fabric of acute care, so much so that it would be hard to imagine a modern hospital without an ICU, dialysis unit, or emergency room. The same should be true for ACE units. Even hospitals without geriatricians on site can use teleconferencing to successfully implement an ACE unit.10 We owe it to our older patients to transform our institutions into AFHS; implementing models of care proven to improve outcomes, such as the ACE unit, is one of the critical first steps.

 

 

Disclosures

The authors have no disclosures or financial conflicts of interest.

Funding

Dr. Walke was supported by an award from the Health Resources and Services Administration Geriatric Workforce Enhancement Program to the University of Pennsylvania (U1QHP28720).

 

References

1. Administration for Community Living. Profile of older adults: 2017. https://acl.gov/sites/default/files/Aging%20and%20Disability%20in%20America/2017OlderAmericansProfile.pdf Accessed April 22, 2019.
2. Gorina Y, Pratt LA, Kramarow EA, Elgaddal N. Hospitalization, readmission, and death experience of noninstitutionalized Medicare fee-for-service beneficiaries aged 65 and over. Hyattsville, MD: National Center for Health Statistics. 2015. PubMed
3. Agency for Healthcare Research and Quality, Medical Expenditure Panel Survey, Household Component 2015. https://meps.ahrq.gov/data_files/publications/st506/stat506.shtml Accessed April 1, 2019.
4. Landefeld CS, Palmer RM, Kresevic DM, Fortinsky RH, Kowal J. A randomized trial of care in a hospital medical unit especially designed to improve the functional outcomes of acutely ill older adults. N Engl J Med. 1995;332(20):1338-1344. https://doi.org/10.1056/NEJM199505183322006.
5. Brennan M, Knee A, Leahy E, et al. An acute care for elders QI program for complex, high cost patients yields savings for the system. J Hosp Med. 2019;14(9):527-533. https://doi.org/10.12788/jhm.3198.
6. Hospital Elder Life Program. https://www.hospitalelderlifeprogram.org/about/results/ Accessed May 6, 2019.
7. Adogwa O, Elsamadicy AA, Vuong VD, et al. Geriatric comanagement reduces perioperative complications and shortens duration of hospital stay after lumbar spine surgery: a prospective single-institution experience. J Neurosurg Spine. 2017;27(6):670-675. https://doi.org/10.3171/2017.5.SPINE17199.
8. Della Rocca GJ, Moylan KC, Crist BD, Volgas DA, Stannard JP, Mehr DR. Comanagement of geriatric patients with hip fracutues: a retrospective, controlled, cohort study. Geriatr Orthop Surg & Rehab.2013;4(1):10-15. https://doi.org/10.1177/2151458513495238.
9. Institute for Healthcare Improvement. http://www.ihi.org/Engage/Initiatives/Age-Friendly-Health-Systems/Pages/default.aspx. Accessed May 6, 2019.
10. Malone ML, Vollbrecht M, Stephenson J, Burke L, Pagel P, Goodwin JS. Acute Care for Elders (ACE) tracker and e-geriatrician: methods to disseminate ACE concepts to hospitals with no geriatricians on staff. J Am Geriatr Soc. 2010;58(1):161-167. https://doi.org/10.1111/j.1532-5415.2009.02624.x.

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Like the rest of the world, the United States is experiencing an aging boom. The number of adults aged 65 years or older is expected to grow from 49 million in 2016 to 82 million in 2040, indicating an increase of 67%. Even more impressively, the population of individuals aged 85 years or older is expected to increase by 129% to 14.6 million within this same time period.1 Considering that one in five Medicare Fee for Service beneficiaries are hospitalized at least once a year,2 hospitals can expect the number of adults over the age of 65 requiring acute care will substantially increase over the next 20 years. These demographic changes have important implications for the overall healthcare costs in the US. Of persons with the highest annual healthcare expenditures, 40% are 65 years of age or older. 3 Thus, optimizing the care of hospitalized older adults will remain a critical component in the management of healthcare costs in the next 20 years.

As such, the Acute Care for the Elderly (ACE) unit, an interprofessional model of care that has been shown to provide high-quality care to hospitalized older adults without increasing costs,4 will become an increasingly important component of acute care as the older adult population grows. In this edition of the Journal of Hospital Medicine, Brennan et al.5 describe a quality improvement initiative in which an interprofessional team that included a geriatric clinician, nurses, pharmacist, and chaplain developed a daily plan of care for ACE unit patients aged 70 years or older. The daily care plan, which focused on symptom management and advance care planning, was the nidus for collaboration between the hospital medicine attending and geriatrics team. Their results demonstrate that ACE unit patients had lower hospital costs and shorter lengths of stay (LOS) as compared with age-matched, usual-care patients despite having higher comorbidity scores. In addition, the greatest benefits were seen among persons in the highest quartile of the comorbidity score.

These results add to the small but consistent body of literature that demonstrates quality and cost benefits to the ACE unit care. Importantly, however, in contrast with the prior ACE unit studies in which persons with moderate risk were the ones to demonstrate the greatest benefits, Brennan et al.5 were able to demonstrate the greatest effect for the highest-need, highest-cost population. Reasons for this impressive effect may be attributed to this intervention’s specific emphasis on symptom management and estimated life expectancy. In an era when Medicare and other payers are looking to increase the value proposition in population health-based approaches by reducing high costs while preserving high quality, these findings represent an important example that merits a broader dissemination.

Of course, ACE units are not the only hospital-based programs that have shown to improve outcomes for older adults. The Hospital Elder Life Program (HELP) is an evidence-based delirium prevention intervention that has been shown to not only prevent delirium but also prevent cognitive and functional decline while decreasing hospital LOS, hospital falls, and sitter use.6 Moreover, similar to ACE units, HELP has been shown to reduce inhospital patient costs. Geriatrics surgery comanagement programs are another hospital-based intervention that has shown to improve outcomes for older surgical patients. Reductions in LOS, improved mobility, and higher discharge to home have been demonstrated in patients who have undergone spinal surgery.7 Decreased LOS and lower hospital costs have also been demonstrated among patients with hip fracture undergoing repair.8 Programs such as ACE units, HELP, and geriatric surgery comanagement are well aligned with the growing emphasis on value-based healthcare and will be especially needed by hospitals that strive to be high-reliability organizations as the number of adults aged 65 and older continues to grow. To date, few studies have explored the potential synergistic effects (or redundancies) of these programs and how to maximize the impact of these evidence-based interventions across healthcare systems with multiple hospitals that care for older adults from various socioeconomic and cultural backgrounds.

Looking toward the future, the implementation of ACE units and other innovative geriatric programs will equip hospitals to develop into Age-Friendly Health Systems (AFHS). AFHS is an initiative being led by the Institute for Healthcare Improvement, The John A. Hartford Foundation, the American Hospital Association, and the Catholic Health Association of the United States in partnership with several other leading healthcare organizations to provide high-value care to every older adult.9 AFHS provide care focused on the 4M framework—What Matters, Medications, Mobility, and Mentation. The goal is for 20% of hospitals and medical practices to join the AFHS initiative by 2020; to date, over 70 organizations nationwide have done so. Clearly, to reach this goal, and beyond, a greater collaboration between aging-focused interprofessional teams including geriatricians and hospitalists will be essential.

Given the aging demographic and rising healthcare costs, Brennan et al.’s work5 suggests that each hospital should have an ACE unit by 2040. Consistently, hospital care delivery has appropriately developed in response to the needs of the patient population served. Intensive care units (ICUs), dialysis units, and emergency rooms are just a few innovations that were adopted by hospitals to provide specialty care to individuals with complex acute illnesses. While technology within the ICU certainly plays a role in the care delivered in that setting, it could be argued that what makes the ICUs most effective is the cohorting of interprofessional expertise. Since the implementation of ICUs, the survival rate for critically ill patients has substantially improved and additional specialty units with an interprofessional team model, eg, cardiac care units, dialysis units, emergency rooms, etc., have followed suit. Specialty units have become a part of the fabric of acute care, so much so that it would be hard to imagine a modern hospital without an ICU, dialysis unit, or emergency room. The same should be true for ACE units. Even hospitals without geriatricians on site can use teleconferencing to successfully implement an ACE unit.10 We owe it to our older patients to transform our institutions into AFHS; implementing models of care proven to improve outcomes, such as the ACE unit, is one of the critical first steps.

 

 

Disclosures

The authors have no disclosures or financial conflicts of interest.

Funding

Dr. Walke was supported by an award from the Health Resources and Services Administration Geriatric Workforce Enhancement Program to the University of Pennsylvania (U1QHP28720).

 

Like the rest of the world, the United States is experiencing an aging boom. The number of adults aged 65 years or older is expected to grow from 49 million in 2016 to 82 million in 2040, indicating an increase of 67%. Even more impressively, the population of individuals aged 85 years or older is expected to increase by 129% to 14.6 million within this same time period.1 Considering that one in five Medicare Fee for Service beneficiaries are hospitalized at least once a year,2 hospitals can expect the number of adults over the age of 65 requiring acute care will substantially increase over the next 20 years. These demographic changes have important implications for the overall healthcare costs in the US. Of persons with the highest annual healthcare expenditures, 40% are 65 years of age or older. 3 Thus, optimizing the care of hospitalized older adults will remain a critical component in the management of healthcare costs in the next 20 years.

As such, the Acute Care for the Elderly (ACE) unit, an interprofessional model of care that has been shown to provide high-quality care to hospitalized older adults without increasing costs,4 will become an increasingly important component of acute care as the older adult population grows. In this edition of the Journal of Hospital Medicine, Brennan et al.5 describe a quality improvement initiative in which an interprofessional team that included a geriatric clinician, nurses, pharmacist, and chaplain developed a daily plan of care for ACE unit patients aged 70 years or older. The daily care plan, which focused on symptom management and advance care planning, was the nidus for collaboration between the hospital medicine attending and geriatrics team. Their results demonstrate that ACE unit patients had lower hospital costs and shorter lengths of stay (LOS) as compared with age-matched, usual-care patients despite having higher comorbidity scores. In addition, the greatest benefits were seen among persons in the highest quartile of the comorbidity score.

These results add to the small but consistent body of literature that demonstrates quality and cost benefits to the ACE unit care. Importantly, however, in contrast with the prior ACE unit studies in which persons with moderate risk were the ones to demonstrate the greatest benefits, Brennan et al.5 were able to demonstrate the greatest effect for the highest-need, highest-cost population. Reasons for this impressive effect may be attributed to this intervention’s specific emphasis on symptom management and estimated life expectancy. In an era when Medicare and other payers are looking to increase the value proposition in population health-based approaches by reducing high costs while preserving high quality, these findings represent an important example that merits a broader dissemination.

Of course, ACE units are not the only hospital-based programs that have shown to improve outcomes for older adults. The Hospital Elder Life Program (HELP) is an evidence-based delirium prevention intervention that has been shown to not only prevent delirium but also prevent cognitive and functional decline while decreasing hospital LOS, hospital falls, and sitter use.6 Moreover, similar to ACE units, HELP has been shown to reduce inhospital patient costs. Geriatrics surgery comanagement programs are another hospital-based intervention that has shown to improve outcomes for older surgical patients. Reductions in LOS, improved mobility, and higher discharge to home have been demonstrated in patients who have undergone spinal surgery.7 Decreased LOS and lower hospital costs have also been demonstrated among patients with hip fracture undergoing repair.8 Programs such as ACE units, HELP, and geriatric surgery comanagement are well aligned with the growing emphasis on value-based healthcare and will be especially needed by hospitals that strive to be high-reliability organizations as the number of adults aged 65 and older continues to grow. To date, few studies have explored the potential synergistic effects (or redundancies) of these programs and how to maximize the impact of these evidence-based interventions across healthcare systems with multiple hospitals that care for older adults from various socioeconomic and cultural backgrounds.

Looking toward the future, the implementation of ACE units and other innovative geriatric programs will equip hospitals to develop into Age-Friendly Health Systems (AFHS). AFHS is an initiative being led by the Institute for Healthcare Improvement, The John A. Hartford Foundation, the American Hospital Association, and the Catholic Health Association of the United States in partnership with several other leading healthcare organizations to provide high-value care to every older adult.9 AFHS provide care focused on the 4M framework—What Matters, Medications, Mobility, and Mentation. The goal is for 20% of hospitals and medical practices to join the AFHS initiative by 2020; to date, over 70 organizations nationwide have done so. Clearly, to reach this goal, and beyond, a greater collaboration between aging-focused interprofessional teams including geriatricians and hospitalists will be essential.

Given the aging demographic and rising healthcare costs, Brennan et al.’s work5 suggests that each hospital should have an ACE unit by 2040. Consistently, hospital care delivery has appropriately developed in response to the needs of the patient population served. Intensive care units (ICUs), dialysis units, and emergency rooms are just a few innovations that were adopted by hospitals to provide specialty care to individuals with complex acute illnesses. While technology within the ICU certainly plays a role in the care delivered in that setting, it could be argued that what makes the ICUs most effective is the cohorting of interprofessional expertise. Since the implementation of ICUs, the survival rate for critically ill patients has substantially improved and additional specialty units with an interprofessional team model, eg, cardiac care units, dialysis units, emergency rooms, etc., have followed suit. Specialty units have become a part of the fabric of acute care, so much so that it would be hard to imagine a modern hospital without an ICU, dialysis unit, or emergency room. The same should be true for ACE units. Even hospitals without geriatricians on site can use teleconferencing to successfully implement an ACE unit.10 We owe it to our older patients to transform our institutions into AFHS; implementing models of care proven to improve outcomes, such as the ACE unit, is one of the critical first steps.

 

 

Disclosures

The authors have no disclosures or financial conflicts of interest.

Funding

Dr. Walke was supported by an award from the Health Resources and Services Administration Geriatric Workforce Enhancement Program to the University of Pennsylvania (U1QHP28720).

 

References

1. Administration for Community Living. Profile of older adults: 2017. https://acl.gov/sites/default/files/Aging%20and%20Disability%20in%20America/2017OlderAmericansProfile.pdf Accessed April 22, 2019.
2. Gorina Y, Pratt LA, Kramarow EA, Elgaddal N. Hospitalization, readmission, and death experience of noninstitutionalized Medicare fee-for-service beneficiaries aged 65 and over. Hyattsville, MD: National Center for Health Statistics. 2015. PubMed
3. Agency for Healthcare Research and Quality, Medical Expenditure Panel Survey, Household Component 2015. https://meps.ahrq.gov/data_files/publications/st506/stat506.shtml Accessed April 1, 2019.
4. Landefeld CS, Palmer RM, Kresevic DM, Fortinsky RH, Kowal J. A randomized trial of care in a hospital medical unit especially designed to improve the functional outcomes of acutely ill older adults. N Engl J Med. 1995;332(20):1338-1344. https://doi.org/10.1056/NEJM199505183322006.
5. Brennan M, Knee A, Leahy E, et al. An acute care for elders QI program for complex, high cost patients yields savings for the system. J Hosp Med. 2019;14(9):527-533. https://doi.org/10.12788/jhm.3198.
6. Hospital Elder Life Program. https://www.hospitalelderlifeprogram.org/about/results/ Accessed May 6, 2019.
7. Adogwa O, Elsamadicy AA, Vuong VD, et al. Geriatric comanagement reduces perioperative complications and shortens duration of hospital stay after lumbar spine surgery: a prospective single-institution experience. J Neurosurg Spine. 2017;27(6):670-675. https://doi.org/10.3171/2017.5.SPINE17199.
8. Della Rocca GJ, Moylan KC, Crist BD, Volgas DA, Stannard JP, Mehr DR. Comanagement of geriatric patients with hip fracutues: a retrospective, controlled, cohort study. Geriatr Orthop Surg & Rehab.2013;4(1):10-15. https://doi.org/10.1177/2151458513495238.
9. Institute for Healthcare Improvement. http://www.ihi.org/Engage/Initiatives/Age-Friendly-Health-Systems/Pages/default.aspx. Accessed May 6, 2019.
10. Malone ML, Vollbrecht M, Stephenson J, Burke L, Pagel P, Goodwin JS. Acute Care for Elders (ACE) tracker and e-geriatrician: methods to disseminate ACE concepts to hospitals with no geriatricians on staff. J Am Geriatr Soc. 2010;58(1):161-167. https://doi.org/10.1111/j.1532-5415.2009.02624.x.

References

1. Administration for Community Living. Profile of older adults: 2017. https://acl.gov/sites/default/files/Aging%20and%20Disability%20in%20America/2017OlderAmericansProfile.pdf Accessed April 22, 2019.
2. Gorina Y, Pratt LA, Kramarow EA, Elgaddal N. Hospitalization, readmission, and death experience of noninstitutionalized Medicare fee-for-service beneficiaries aged 65 and over. Hyattsville, MD: National Center for Health Statistics. 2015. PubMed
3. Agency for Healthcare Research and Quality, Medical Expenditure Panel Survey, Household Component 2015. https://meps.ahrq.gov/data_files/publications/st506/stat506.shtml Accessed April 1, 2019.
4. Landefeld CS, Palmer RM, Kresevic DM, Fortinsky RH, Kowal J. A randomized trial of care in a hospital medical unit especially designed to improve the functional outcomes of acutely ill older adults. N Engl J Med. 1995;332(20):1338-1344. https://doi.org/10.1056/NEJM199505183322006.
5. Brennan M, Knee A, Leahy E, et al. An acute care for elders QI program for complex, high cost patients yields savings for the system. J Hosp Med. 2019;14(9):527-533. https://doi.org/10.12788/jhm.3198.
6. Hospital Elder Life Program. https://www.hospitalelderlifeprogram.org/about/results/ Accessed May 6, 2019.
7. Adogwa O, Elsamadicy AA, Vuong VD, et al. Geriatric comanagement reduces perioperative complications and shortens duration of hospital stay after lumbar spine surgery: a prospective single-institution experience. J Neurosurg Spine. 2017;27(6):670-675. https://doi.org/10.3171/2017.5.SPINE17199.
8. Della Rocca GJ, Moylan KC, Crist BD, Volgas DA, Stannard JP, Mehr DR. Comanagement of geriatric patients with hip fracutues: a retrospective, controlled, cohort study. Geriatr Orthop Surg & Rehab.2013;4(1):10-15. https://doi.org/10.1177/2151458513495238.
9. Institute for Healthcare Improvement. http://www.ihi.org/Engage/Initiatives/Age-Friendly-Health-Systems/Pages/default.aspx. Accessed May 6, 2019.
10. Malone ML, Vollbrecht M, Stephenson J, Burke L, Pagel P, Goodwin JS. Acute Care for Elders (ACE) tracker and e-geriatrician: methods to disseminate ACE concepts to hospitals with no geriatricians on staff. J Am Geriatr Soc. 2010;58(1):161-167. https://doi.org/10.1111/j.1532-5415.2009.02624.x.

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Patient Perspective is Critical in Developing Interventions for Frequently Admitted Patients

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In the context of rapidly rising healthcare costs and increasing disparities in health outcomes in the United States, there has been increasing interest in identifying and addressing the needs of our country’s most frequently admitted patients. These patients account for a disproportionate percentage of healthcare expenditures1-3; they also represent a vulnerable and high-risk population. Finding solutions to address the needs of these patients is important for the patients themselves and for the systems in which they receive care. The last 10-15 years have seen a proliferation of programs working to address the needs and contain the costs of frequently admitted patients,2,4-6 as well as increased interest in understanding the risk factors and drivers that lead to high utilization.

In this edition of the Journal of Hospital Medicine, O’Leary et al. report on their study of patients enrolled in the CHAMP program at Northwestern University, in which the authors elicit patients’ perceptions of factors contributing to the onset and continuation of high hospital use.7 The authors identify several themes, including the important role of psychological, social, and economic factors in course fluctuation, the perception of acute illness as uncontrollable and unpredictable, and a strong desire to avoid hospitalization. As a group, the themes suggest multiple strategies that may be of use in developing individualized plans for patients.

Several of the most commonly cited risk factors for high utilization—including mental health issues, housing insecurity or homelessness, and substance use2,3,8,9—did not emerge as themes identified by patients in this study as contributing to high hospital utilization. Although identified themes such as social support and psychological stress could certainly be related to these underlying risk factors, the risk factors themselves did not emerge. This is particularly notable in a population whose utilization is in line with other studies (participants had at least two unplanned 30-day inpatient readmissions within 12 months, and one readmission in the last six months, a referral, or at least three observation visits). In contrast to prior qualitative work with complex, high-needs patients,10 patients in this study did not identify difficult (or positive) relationships with care provider teams, or a history of early life trauma, as factors related to current utilization.

These findings raise several important questions. To what extent are frequently hospitalized patient populations comparable with each other? This is both a question about how populations are defined and a question about the inherent variability between populations (including geographic, social, socioeconomic, and other factors). It is not evident from the demographic information provided whether this population is fundamentally different from others that have been studied, or whether risk factors such as mental health issues, housing insecurity, substance abuse, and trauma history are present, but are just not identified by patients here as proximal contributors to their utilization. In either case, the findings raise important questions about the development of effective interventions for these patients. The discrepancies also highlight the utility of ascertaining and reporting the prevalence of these risk factors among study populations, ideally both among patients who opt in and those who opt out. Although obtaining this information adds an additional layer of complexity to data collection, this history, along with extended demographic data, would significantly improve our ability to assess the comparability of populations across studies. It would also help us understand whether perspectives of any specific groups of patients are not represented, due to frequent opting out of the study.

The fact that commonly identified risk factors for high utilization are not identified by patients in this study as contributing to their high hospital use highlights the importance of (1) including the patient perspective as an integral part of care plan and intervention development and (2) continuing local work aimed at understanding the risk factors and drivers of high utilization in specific populations. Many programs, including CHAMP at Northwestern and our own hospitalist-run program at Penn Medicine, work closely with patients to develop individualized care plans that aim to address the underlying drivers of high utilization. In our experience, a multidisciplinary committee reviewing patient cases has identified mental health conditions as likely drivers of frequent admissions in over 95% of program patients. In line with the findings here, however, patients themselves often do not see mental health as a significant contributor. If patients do not see factors such as mental health as important, this has significant implications for the development of interventions around these factors as part of a solution to high hospital use.

Patients are unlikely to respond to interventions targeting problems that they themselves do not identify as important. This is not to say that drivers such as mental health, housing instability, substance abuse, and behaviors rooted in childhood trauma cannot be addressed if they are not identified by a patient as problems. Rather, interventions must be sensitive to and developed within the context of the patient’s own perceptions and priorities. For any program aimed at addressing the underlying drivers of high utilization, therefore, it is critical to elicit individual patient perspectives and to incorporate them in the development of interventions tailored to a specific patient’s needs. This process not only informs the creation of an individualized care plan but also promotes engagement and builds trust.

In prior work,6 O’Leary et al. have joined others throughout the field in calling for standardized definitions of “high utilizers”; this is critical for our ability to compare study results across programs. However, standardizing definitions is just the first step. Individual site studies such as this are needed to help us understand which themes are universal, versus those that are population- and site-specific. They are also important for individual institutions in targeting, developing, and refining local interventions. As a whole, the results will help guide the development of best practices within the field and allow providers to better understand the needs of specific populations. This work is essential to our ability as providers, hospitals, and systems to develop effective interventions for individual patients in this heterogeneous, vulnerable, and high-risk population.

 

 

Disclosures

Dr. Knox and Dr. Greysen have nothing to disclose.

 

References

1. Stanton MW, Rutherford MK. The high concentration of U.S. health care expenditures. Research in Action Issue 19. 2005. Rockville, MD: Agency for Healthcare Research and Quality.
2. Center for Health Care Strategies (CHCS). “Super-utilizer summit: common themes from innovative complex care management programs.” CHCS. 2013.
3. Jiang H, Weiss A, Barrett M, Sheng M. Characteristics of hospital stays for super-utilizers by payer, 2012: Statistical Brief #190. PubMed
4. Bodenheimer T. Strategies to reduce costs and improve care for high-utilizing medicaid patients: reflections on pioneering programs. CHCS. 2013.
5. Hong C , Siegel A, Ferris T. Caring for high-need, high-cost patients: what makes for a successful care management program? New York (NY): Commonwealth Fund. 2014;19(1):1-19. PubMed
6. Goodwin A, Henschen BL, O’Dwyer LC, Nichols N, O’Leary KJ. Interventions for frequently hospitalized patients and their effect on outcomes: a systematic review. J Hosp Med. 2018;13(12):853-859. https://doi.org/10.12788/jhm.3090.
7. O’Leary K, Chapman M, Shandu F et al. Frequently hospitalized patients’ perceptions of factors contributing to high hospital use. J Hosp Med. 2019;14(9):521-526. https://doi.org/10.12788/jhm.3175.
8. Johnson TL, Rinehart DJ, Durfee J, et al. For many patients who use large amounts of health care services, the need is intense yet temporary. Health Aff. 2015;34(8):1312-1319. https://doi.org/10.1377/hlthaff.2014.1186.
9. Rinehart DJ, Oronce C, Durfee MJ, et al. Identifying subgroups of adult superutilizers in an urban safety-net system using latent class analysis: implications for clinical practice. Med Care. 2018;56(1):e1-e9. https://doi.org/10.1097/MLR.0000000000000628.
10. Mautner DB, Pang H, Brenner JC, et al. Generating hypotheses about care needs of high utilizers: lessons from patient interviews. Popul Health Manag. 2013;16(1):S26-S33. https://doi.org/10.1089/pop.2013.0033.

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In the context of rapidly rising healthcare costs and increasing disparities in health outcomes in the United States, there has been increasing interest in identifying and addressing the needs of our country’s most frequently admitted patients. These patients account for a disproportionate percentage of healthcare expenditures1-3; they also represent a vulnerable and high-risk population. Finding solutions to address the needs of these patients is important for the patients themselves and for the systems in which they receive care. The last 10-15 years have seen a proliferation of programs working to address the needs and contain the costs of frequently admitted patients,2,4-6 as well as increased interest in understanding the risk factors and drivers that lead to high utilization.

In this edition of the Journal of Hospital Medicine, O’Leary et al. report on their study of patients enrolled in the CHAMP program at Northwestern University, in which the authors elicit patients’ perceptions of factors contributing to the onset and continuation of high hospital use.7 The authors identify several themes, including the important role of psychological, social, and economic factors in course fluctuation, the perception of acute illness as uncontrollable and unpredictable, and a strong desire to avoid hospitalization. As a group, the themes suggest multiple strategies that may be of use in developing individualized plans for patients.

Several of the most commonly cited risk factors for high utilization—including mental health issues, housing insecurity or homelessness, and substance use2,3,8,9—did not emerge as themes identified by patients in this study as contributing to high hospital utilization. Although identified themes such as social support and psychological stress could certainly be related to these underlying risk factors, the risk factors themselves did not emerge. This is particularly notable in a population whose utilization is in line with other studies (participants had at least two unplanned 30-day inpatient readmissions within 12 months, and one readmission in the last six months, a referral, or at least three observation visits). In contrast to prior qualitative work with complex, high-needs patients,10 patients in this study did not identify difficult (or positive) relationships with care provider teams, or a history of early life trauma, as factors related to current utilization.

These findings raise several important questions. To what extent are frequently hospitalized patient populations comparable with each other? This is both a question about how populations are defined and a question about the inherent variability between populations (including geographic, social, socioeconomic, and other factors). It is not evident from the demographic information provided whether this population is fundamentally different from others that have been studied, or whether risk factors such as mental health issues, housing insecurity, substance abuse, and trauma history are present, but are just not identified by patients here as proximal contributors to their utilization. In either case, the findings raise important questions about the development of effective interventions for these patients. The discrepancies also highlight the utility of ascertaining and reporting the prevalence of these risk factors among study populations, ideally both among patients who opt in and those who opt out. Although obtaining this information adds an additional layer of complexity to data collection, this history, along with extended demographic data, would significantly improve our ability to assess the comparability of populations across studies. It would also help us understand whether perspectives of any specific groups of patients are not represented, due to frequent opting out of the study.

The fact that commonly identified risk factors for high utilization are not identified by patients in this study as contributing to their high hospital use highlights the importance of (1) including the patient perspective as an integral part of care plan and intervention development and (2) continuing local work aimed at understanding the risk factors and drivers of high utilization in specific populations. Many programs, including CHAMP at Northwestern and our own hospitalist-run program at Penn Medicine, work closely with patients to develop individualized care plans that aim to address the underlying drivers of high utilization. In our experience, a multidisciplinary committee reviewing patient cases has identified mental health conditions as likely drivers of frequent admissions in over 95% of program patients. In line with the findings here, however, patients themselves often do not see mental health as a significant contributor. If patients do not see factors such as mental health as important, this has significant implications for the development of interventions around these factors as part of a solution to high hospital use.

Patients are unlikely to respond to interventions targeting problems that they themselves do not identify as important. This is not to say that drivers such as mental health, housing instability, substance abuse, and behaviors rooted in childhood trauma cannot be addressed if they are not identified by a patient as problems. Rather, interventions must be sensitive to and developed within the context of the patient’s own perceptions and priorities. For any program aimed at addressing the underlying drivers of high utilization, therefore, it is critical to elicit individual patient perspectives and to incorporate them in the development of interventions tailored to a specific patient’s needs. This process not only informs the creation of an individualized care plan but also promotes engagement and builds trust.

In prior work,6 O’Leary et al. have joined others throughout the field in calling for standardized definitions of “high utilizers”; this is critical for our ability to compare study results across programs. However, standardizing definitions is just the first step. Individual site studies such as this are needed to help us understand which themes are universal, versus those that are population- and site-specific. They are also important for individual institutions in targeting, developing, and refining local interventions. As a whole, the results will help guide the development of best practices within the field and allow providers to better understand the needs of specific populations. This work is essential to our ability as providers, hospitals, and systems to develop effective interventions for individual patients in this heterogeneous, vulnerable, and high-risk population.

 

 

Disclosures

Dr. Knox and Dr. Greysen have nothing to disclose.

 

In the context of rapidly rising healthcare costs and increasing disparities in health outcomes in the United States, there has been increasing interest in identifying and addressing the needs of our country’s most frequently admitted patients. These patients account for a disproportionate percentage of healthcare expenditures1-3; they also represent a vulnerable and high-risk population. Finding solutions to address the needs of these patients is important for the patients themselves and for the systems in which they receive care. The last 10-15 years have seen a proliferation of programs working to address the needs and contain the costs of frequently admitted patients,2,4-6 as well as increased interest in understanding the risk factors and drivers that lead to high utilization.

In this edition of the Journal of Hospital Medicine, O’Leary et al. report on their study of patients enrolled in the CHAMP program at Northwestern University, in which the authors elicit patients’ perceptions of factors contributing to the onset and continuation of high hospital use.7 The authors identify several themes, including the important role of psychological, social, and economic factors in course fluctuation, the perception of acute illness as uncontrollable and unpredictable, and a strong desire to avoid hospitalization. As a group, the themes suggest multiple strategies that may be of use in developing individualized plans for patients.

Several of the most commonly cited risk factors for high utilization—including mental health issues, housing insecurity or homelessness, and substance use2,3,8,9—did not emerge as themes identified by patients in this study as contributing to high hospital utilization. Although identified themes such as social support and psychological stress could certainly be related to these underlying risk factors, the risk factors themselves did not emerge. This is particularly notable in a population whose utilization is in line with other studies (participants had at least two unplanned 30-day inpatient readmissions within 12 months, and one readmission in the last six months, a referral, or at least three observation visits). In contrast to prior qualitative work with complex, high-needs patients,10 patients in this study did not identify difficult (or positive) relationships with care provider teams, or a history of early life trauma, as factors related to current utilization.

These findings raise several important questions. To what extent are frequently hospitalized patient populations comparable with each other? This is both a question about how populations are defined and a question about the inherent variability between populations (including geographic, social, socioeconomic, and other factors). It is not evident from the demographic information provided whether this population is fundamentally different from others that have been studied, or whether risk factors such as mental health issues, housing insecurity, substance abuse, and trauma history are present, but are just not identified by patients here as proximal contributors to their utilization. In either case, the findings raise important questions about the development of effective interventions for these patients. The discrepancies also highlight the utility of ascertaining and reporting the prevalence of these risk factors among study populations, ideally both among patients who opt in and those who opt out. Although obtaining this information adds an additional layer of complexity to data collection, this history, along with extended demographic data, would significantly improve our ability to assess the comparability of populations across studies. It would also help us understand whether perspectives of any specific groups of patients are not represented, due to frequent opting out of the study.

The fact that commonly identified risk factors for high utilization are not identified by patients in this study as contributing to their high hospital use highlights the importance of (1) including the patient perspective as an integral part of care plan and intervention development and (2) continuing local work aimed at understanding the risk factors and drivers of high utilization in specific populations. Many programs, including CHAMP at Northwestern and our own hospitalist-run program at Penn Medicine, work closely with patients to develop individualized care plans that aim to address the underlying drivers of high utilization. In our experience, a multidisciplinary committee reviewing patient cases has identified mental health conditions as likely drivers of frequent admissions in over 95% of program patients. In line with the findings here, however, patients themselves often do not see mental health as a significant contributor. If patients do not see factors such as mental health as important, this has significant implications for the development of interventions around these factors as part of a solution to high hospital use.

Patients are unlikely to respond to interventions targeting problems that they themselves do not identify as important. This is not to say that drivers such as mental health, housing instability, substance abuse, and behaviors rooted in childhood trauma cannot be addressed if they are not identified by a patient as problems. Rather, interventions must be sensitive to and developed within the context of the patient’s own perceptions and priorities. For any program aimed at addressing the underlying drivers of high utilization, therefore, it is critical to elicit individual patient perspectives and to incorporate them in the development of interventions tailored to a specific patient’s needs. This process not only informs the creation of an individualized care plan but also promotes engagement and builds trust.

In prior work,6 O’Leary et al. have joined others throughout the field in calling for standardized definitions of “high utilizers”; this is critical for our ability to compare study results across programs. However, standardizing definitions is just the first step. Individual site studies such as this are needed to help us understand which themes are universal, versus those that are population- and site-specific. They are also important for individual institutions in targeting, developing, and refining local interventions. As a whole, the results will help guide the development of best practices within the field and allow providers to better understand the needs of specific populations. This work is essential to our ability as providers, hospitals, and systems to develop effective interventions for individual patients in this heterogeneous, vulnerable, and high-risk population.

 

 

Disclosures

Dr. Knox and Dr. Greysen have nothing to disclose.

 

References

1. Stanton MW, Rutherford MK. The high concentration of U.S. health care expenditures. Research in Action Issue 19. 2005. Rockville, MD: Agency for Healthcare Research and Quality.
2. Center for Health Care Strategies (CHCS). “Super-utilizer summit: common themes from innovative complex care management programs.” CHCS. 2013.
3. Jiang H, Weiss A, Barrett M, Sheng M. Characteristics of hospital stays for super-utilizers by payer, 2012: Statistical Brief #190. PubMed
4. Bodenheimer T. Strategies to reduce costs and improve care for high-utilizing medicaid patients: reflections on pioneering programs. CHCS. 2013.
5. Hong C , Siegel A, Ferris T. Caring for high-need, high-cost patients: what makes for a successful care management program? New York (NY): Commonwealth Fund. 2014;19(1):1-19. PubMed
6. Goodwin A, Henschen BL, O’Dwyer LC, Nichols N, O’Leary KJ. Interventions for frequently hospitalized patients and their effect on outcomes: a systematic review. J Hosp Med. 2018;13(12):853-859. https://doi.org/10.12788/jhm.3090.
7. O’Leary K, Chapman M, Shandu F et al. Frequently hospitalized patients’ perceptions of factors contributing to high hospital use. J Hosp Med. 2019;14(9):521-526. https://doi.org/10.12788/jhm.3175.
8. Johnson TL, Rinehart DJ, Durfee J, et al. For many patients who use large amounts of health care services, the need is intense yet temporary. Health Aff. 2015;34(8):1312-1319. https://doi.org/10.1377/hlthaff.2014.1186.
9. Rinehart DJ, Oronce C, Durfee MJ, et al. Identifying subgroups of adult superutilizers in an urban safety-net system using latent class analysis: implications for clinical practice. Med Care. 2018;56(1):e1-e9. https://doi.org/10.1097/MLR.0000000000000628.
10. Mautner DB, Pang H, Brenner JC, et al. Generating hypotheses about care needs of high utilizers: lessons from patient interviews. Popul Health Manag. 2013;16(1):S26-S33. https://doi.org/10.1089/pop.2013.0033.

References

1. Stanton MW, Rutherford MK. The high concentration of U.S. health care expenditures. Research in Action Issue 19. 2005. Rockville, MD: Agency for Healthcare Research and Quality.
2. Center for Health Care Strategies (CHCS). “Super-utilizer summit: common themes from innovative complex care management programs.” CHCS. 2013.
3. Jiang H, Weiss A, Barrett M, Sheng M. Characteristics of hospital stays for super-utilizers by payer, 2012: Statistical Brief #190. PubMed
4. Bodenheimer T. Strategies to reduce costs and improve care for high-utilizing medicaid patients: reflections on pioneering programs. CHCS. 2013.
5. Hong C , Siegel A, Ferris T. Caring for high-need, high-cost patients: what makes for a successful care management program? New York (NY): Commonwealth Fund. 2014;19(1):1-19. PubMed
6. Goodwin A, Henschen BL, O’Dwyer LC, Nichols N, O’Leary KJ. Interventions for frequently hospitalized patients and their effect on outcomes: a systematic review. J Hosp Med. 2018;13(12):853-859. https://doi.org/10.12788/jhm.3090.
7. O’Leary K, Chapman M, Shandu F et al. Frequently hospitalized patients’ perceptions of factors contributing to high hospital use. J Hosp Med. 2019;14(9):521-526. https://doi.org/10.12788/jhm.3175.
8. Johnson TL, Rinehart DJ, Durfee J, et al. For many patients who use large amounts of health care services, the need is intense yet temporary. Health Aff. 2015;34(8):1312-1319. https://doi.org/10.1377/hlthaff.2014.1186.
9. Rinehart DJ, Oronce C, Durfee MJ, et al. Identifying subgroups of adult superutilizers in an urban safety-net system using latent class analysis: implications for clinical practice. Med Care. 2018;56(1):e1-e9. https://doi.org/10.1097/MLR.0000000000000628.
10. Mautner DB, Pang H, Brenner JC, et al. Generating hypotheses about care needs of high utilizers: lessons from patient interviews. Popul Health Manag. 2013;16(1):S26-S33. https://doi.org/10.1089/pop.2013.0033.

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Leadership & Professional Development: Searching for Ideas Close to Home

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As hospitalists, many of us see things in our daily practice that help inform our efforts to improve quality of care, organizational efficiency, and medical education, and to reduce physician burnout. But many of those efforts, while well intended, lack rigorous empirical evaluation.

Indeed, it is the complexity of hospital care that leads scholars across many disciplines—including economics, epidemiology, and sociology—to look to hospital medicine as a place where “natural experimentation” can inform us about what works and doesn’t work in medical care. As a hospitalist and economist, I find that the very best of my ideas come from what I see in the hospital. And for many hospital-based clinicians and physician leaders, translating everyday insights into rigorous scientific explorations is not only feasible but is a natural extension of the curiosity that drives good clinical work. It is also a way to drive quality improvement.

Consider, for example, a question that hospitalists face every day: when to discharge a patient from the hospital. Hospital leaders and frontline clinicians are increasingly under pressure to discharge patients earlier and earlier, with some concerned that earlier discharge poses safety risks. Short of randomizing patients to earlier discharge and studying the effects on outcomes, how can a data-driven hospital leader identify which patients can be safely discharged earlier and how much earlier?

A simple observation of a practicing hospitalist could be a clue to elegantly and rigorously answering this question. It turns out that some patients happen to be hospitalized days before their birthday and it wouldn’t be absurd to think that a physician treating such a patient might be more likely to discharge that patient home on or before their birthday so they can celebrate it at home. The same might be true for patients who are in the hospital before an impending storm. Patient-level data could be used to assess whether length of stay is shorter for patients who are admitted to the hospital a few days before their birthday (or just before a storm), compared with otherwise similar patients admitted to the hospital several weeks earlier, and whether outcomes are any different, on average, or in specific subpopulations. For hospital leaders, this could not only be convincing “quasi-experimental” evidence that length of stay can be safely reduced, but it could also contribute to the scholarly literature.

How can hospitalists generate ideas like these, rigorously evaluate them, and translate them into practice? It turns out that examples such as these abound for the practicing hospitalist, yet few draw the link between these everyday phenomena and the larger question of how length of stay affects patient outcomes. To start, a systematic approach to generating ideas is important: “idea rounds”—a dedicated group discussion in which physicians and other providers brainstorm ideas for quality improvement—can leverage the wisdom of frontline clinicians. But, clever insights aren’t enough. Data and statistical expertise are needed, but with the growing use of electronic health record data and administrative data from large insurers, lack of data is less of a challenge. The larger challenge is data expertise. Data-driven hospital leaders should invest in personnel with statistical expertise to not only complement the scholarly endeavors of hospital medicine faculty, but also to conduct larger, more rigorous quality improvement studies. Particularly as hospitals are increasingly being measured and reimbursed on the basis of data-oriented quality-of-care metrics, it makes sense for hospital leaders to analogously invest in data infrastructure and the analytic capability to analyze that data. The innovation of this approach lies in the simple insight that the everyday activities of hospitalists can be used to answer interesting questions about what works, what doesn’t, and potentially why in healthcare.

 

 

Disclosures

Dr. Jena reports receiving consulting fees unrelated to this work from Pfizer, Hill Rom Services, Bristol Myers Squibb, Novartis, Amgen, Eli Lilly, Vertex Pharmaceuticals, AstraZeneca, Celgene, Tesaro, Sanofi Aventis, Biogen, Precision Health Economics, and Analysis Group.

Funding

Support was provided by the Office of the Director, National Institutes of Health (1DP5OD017897, Dr. Jena).

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As hospitalists, many of us see things in our daily practice that help inform our efforts to improve quality of care, organizational efficiency, and medical education, and to reduce physician burnout. But many of those efforts, while well intended, lack rigorous empirical evaluation.

Indeed, it is the complexity of hospital care that leads scholars across many disciplines—including economics, epidemiology, and sociology—to look to hospital medicine as a place where “natural experimentation” can inform us about what works and doesn’t work in medical care. As a hospitalist and economist, I find that the very best of my ideas come from what I see in the hospital. And for many hospital-based clinicians and physician leaders, translating everyday insights into rigorous scientific explorations is not only feasible but is a natural extension of the curiosity that drives good clinical work. It is also a way to drive quality improvement.

Consider, for example, a question that hospitalists face every day: when to discharge a patient from the hospital. Hospital leaders and frontline clinicians are increasingly under pressure to discharge patients earlier and earlier, with some concerned that earlier discharge poses safety risks. Short of randomizing patients to earlier discharge and studying the effects on outcomes, how can a data-driven hospital leader identify which patients can be safely discharged earlier and how much earlier?

A simple observation of a practicing hospitalist could be a clue to elegantly and rigorously answering this question. It turns out that some patients happen to be hospitalized days before their birthday and it wouldn’t be absurd to think that a physician treating such a patient might be more likely to discharge that patient home on or before their birthday so they can celebrate it at home. The same might be true for patients who are in the hospital before an impending storm. Patient-level data could be used to assess whether length of stay is shorter for patients who are admitted to the hospital a few days before their birthday (or just before a storm), compared with otherwise similar patients admitted to the hospital several weeks earlier, and whether outcomes are any different, on average, or in specific subpopulations. For hospital leaders, this could not only be convincing “quasi-experimental” evidence that length of stay can be safely reduced, but it could also contribute to the scholarly literature.

How can hospitalists generate ideas like these, rigorously evaluate them, and translate them into practice? It turns out that examples such as these abound for the practicing hospitalist, yet few draw the link between these everyday phenomena and the larger question of how length of stay affects patient outcomes. To start, a systematic approach to generating ideas is important: “idea rounds”—a dedicated group discussion in which physicians and other providers brainstorm ideas for quality improvement—can leverage the wisdom of frontline clinicians. But, clever insights aren’t enough. Data and statistical expertise are needed, but with the growing use of electronic health record data and administrative data from large insurers, lack of data is less of a challenge. The larger challenge is data expertise. Data-driven hospital leaders should invest in personnel with statistical expertise to not only complement the scholarly endeavors of hospital medicine faculty, but also to conduct larger, more rigorous quality improvement studies. Particularly as hospitals are increasingly being measured and reimbursed on the basis of data-oriented quality-of-care metrics, it makes sense for hospital leaders to analogously invest in data infrastructure and the analytic capability to analyze that data. The innovation of this approach lies in the simple insight that the everyday activities of hospitalists can be used to answer interesting questions about what works, what doesn’t, and potentially why in healthcare.

 

 

Disclosures

Dr. Jena reports receiving consulting fees unrelated to this work from Pfizer, Hill Rom Services, Bristol Myers Squibb, Novartis, Amgen, Eli Lilly, Vertex Pharmaceuticals, AstraZeneca, Celgene, Tesaro, Sanofi Aventis, Biogen, Precision Health Economics, and Analysis Group.

Funding

Support was provided by the Office of the Director, National Institutes of Health (1DP5OD017897, Dr. Jena).

As hospitalists, many of us see things in our daily practice that help inform our efforts to improve quality of care, organizational efficiency, and medical education, and to reduce physician burnout. But many of those efforts, while well intended, lack rigorous empirical evaluation.

Indeed, it is the complexity of hospital care that leads scholars across many disciplines—including economics, epidemiology, and sociology—to look to hospital medicine as a place where “natural experimentation” can inform us about what works and doesn’t work in medical care. As a hospitalist and economist, I find that the very best of my ideas come from what I see in the hospital. And for many hospital-based clinicians and physician leaders, translating everyday insights into rigorous scientific explorations is not only feasible but is a natural extension of the curiosity that drives good clinical work. It is also a way to drive quality improvement.

Consider, for example, a question that hospitalists face every day: when to discharge a patient from the hospital. Hospital leaders and frontline clinicians are increasingly under pressure to discharge patients earlier and earlier, with some concerned that earlier discharge poses safety risks. Short of randomizing patients to earlier discharge and studying the effects on outcomes, how can a data-driven hospital leader identify which patients can be safely discharged earlier and how much earlier?

A simple observation of a practicing hospitalist could be a clue to elegantly and rigorously answering this question. It turns out that some patients happen to be hospitalized days before their birthday and it wouldn’t be absurd to think that a physician treating such a patient might be more likely to discharge that patient home on or before their birthday so they can celebrate it at home. The same might be true for patients who are in the hospital before an impending storm. Patient-level data could be used to assess whether length of stay is shorter for patients who are admitted to the hospital a few days before their birthday (or just before a storm), compared with otherwise similar patients admitted to the hospital several weeks earlier, and whether outcomes are any different, on average, or in specific subpopulations. For hospital leaders, this could not only be convincing “quasi-experimental” evidence that length of stay can be safely reduced, but it could also contribute to the scholarly literature.

How can hospitalists generate ideas like these, rigorously evaluate them, and translate them into practice? It turns out that examples such as these abound for the practicing hospitalist, yet few draw the link between these everyday phenomena and the larger question of how length of stay affects patient outcomes. To start, a systematic approach to generating ideas is important: “idea rounds”—a dedicated group discussion in which physicians and other providers brainstorm ideas for quality improvement—can leverage the wisdom of frontline clinicians. But, clever insights aren’t enough. Data and statistical expertise are needed, but with the growing use of electronic health record data and administrative data from large insurers, lack of data is less of a challenge. The larger challenge is data expertise. Data-driven hospital leaders should invest in personnel with statistical expertise to not only complement the scholarly endeavors of hospital medicine faculty, but also to conduct larger, more rigorous quality improvement studies. Particularly as hospitals are increasingly being measured and reimbursed on the basis of data-oriented quality-of-care metrics, it makes sense for hospital leaders to analogously invest in data infrastructure and the analytic capability to analyze that data. The innovation of this approach lies in the simple insight that the everyday activities of hospitalists can be used to answer interesting questions about what works, what doesn’t, and potentially why in healthcare.

 

 

Disclosures

Dr. Jena reports receiving consulting fees unrelated to this work from Pfizer, Hill Rom Services, Bristol Myers Squibb, Novartis, Amgen, Eli Lilly, Vertex Pharmaceuticals, AstraZeneca, Celgene, Tesaro, Sanofi Aventis, Biogen, Precision Health Economics, and Analysis Group.

Funding

Support was provided by the Office of the Director, National Institutes of Health (1DP5OD017897, Dr. Jena).

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Anupam B Jena, MD, PhD; E-mail: [email protected]; Telephone: 617-432-8322; Twitter: @AnupamBJena
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Axial SpA guidelines updated with best practices for new drugs, imaging

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The American College of Rheumatology, Spondylitis Association of America, and Spondyloarthritis Research and Treatment Network have updated their guidelines on management of ankylosing spondylitis and nonradiographic axial spondyloarthritis.

Dr. Michael M. Ward

These guidelines serve as an update to the previous guidelines that were first published in 2015 (Arthritis Care Res. 2016;68:151–66). While the new guidelines did not review all recommendations from the 2015 guidelines, 20 questions on pharmacologic treatment were re-reviewed in addition to 26 new questions and recommendations.

Michael M. Ward, MD, chief of the Clinical Trials and Outcomes Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, said in an interview that the availability of new medications to treat axial spondyloarthritis (axSpA) prompted the updated guidelines.

“We took the opportunity to revisit some previous recommendations for which substantial new evidence was available, and also included new recommendations on some other topics, such as imaging,” said Dr. Ward, who is also first author of the new guidelines.

The panel that developed the questions focused on scenarios that a clinician would likely encounter in clinical practice, or situations in which how to manage a case is not clear. “Given this perspective, there were many questions that had limited evidence, but recommendations were made for all questions. For those questions that had less evidence in the literature, we relied more on the expertise of the panel,” Dr. Ward said.

The questions and recommendations for ankylosing spondylitis (AS) and nonradiographic axSpA centered around use of interleukin-17 (IL-17) inhibitors, tofacitinib (Xeljanz), and biosimilars of tumor necrosis factor-alpha inhibitors (TNFi), as well as when to taper and discontinue these medications.

Strong recommendations for patients with AS included using NSAIDs (low level of evidence), using TNFi when active disease remains despite NSAID treatment (high level of evidence), and using secukinumab (Cosentyx) or ixekizumab (Taltz) when active disease remains despite NSAID treatment over no treatment (high level of evidence). The guidelines also strongly recommend the use of physical therapy for adults with stable AS over no physical therapy (low level of evidence), as well as total hip arthroplasty in cases of advanced hip arthritis. The writing panel also strongly advised that adults with AS-related comorbidities should receive treatment by an ophthalmologist in cases of acute iritis. Strong recommendations were made against switching to a biosimilar of a TNFi after receiving treatment with an originator TNFi (regardless of whether it is for active or stable AS), use of systemic glucocorticoids in adults with active AS, treatment with spinal manipulation in patients with spinal fusion or advanced spinal osteoporosis, and screening for cardiac conduction defects and valvular heart disease with electrocardiograms.

Strong recommendations for nonradiographic axSpA were similar to those made for patients with AS, and the panel made strong recommendations for use of NSAIDs in patients with active disease; for TNFi treatment when NSAIDs fail; against switching to a biosimilar of a TNFi after starting the originator TNFi; against using systemic glucocorticoids; and in favor of using physical therapy rather than not.

The panel also made a number of conditional recommendations for AS and nonradiographic axSpA patients with regard to biologic preference and imaging. TNFis were conditionally recommended over secukinumab or ixekizumab in patients with active disease despite NSAIDs treatment, and in cases where a patient is not responding to a first TNFi treatment, the panel conditionally recommended secukinumab or ixekizumab over a second TNFi (very low evidence for all). Secukinumab or ixekizumab were also conditionally recommended over tofacitinib (very low evidence). Sulfasalazine, methotrexate, and tofacitinib were conditionally recommended in cases where patients had prominent peripheral arthritis or when TNFis are not available (very low to moderate evidence). The panel recommended against adding sulfasalazine or methotrexate to existing TNFi treatment (very low evidence), and they also advised against tapering as a standard treatment approach or discontinuing the biologic (very low evidence). MRI of the spine or pelvis was conditionally recommended to examine disease activity in unclear cases, but the panel recommended against ordering MRI scans to monitor disease inactivity (very low evidence).

“Most of the recommendations are conditional, primarily because of the relatively low level of evidence in the literature that addressed many of the questions,” while stronger recommendations came from larger clinical trials, Dr. Ward said. “The need for this update demonstrates the rapid progress in treatment that is occurring in axial spondyloarthritis, but the low level of evidence for many questions indicates that much more research is needed.”

Nine authors reported personal and institutional relationships in the form of consultancies, educational advisory board memberships, and site investigator appointments for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Galapagos, Janssen, Novartis, Pfizer, and UCB. The other authors reported no relevant conflicts of interest.

SOURCE: Ward MM et al. Arthritis Care Res. 2019 Aug 21. doi: 10.1002/acr.24025.

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The American College of Rheumatology, Spondylitis Association of America, and Spondyloarthritis Research and Treatment Network have updated their guidelines on management of ankylosing spondylitis and nonradiographic axial spondyloarthritis.

Dr. Michael M. Ward

These guidelines serve as an update to the previous guidelines that were first published in 2015 (Arthritis Care Res. 2016;68:151–66). While the new guidelines did not review all recommendations from the 2015 guidelines, 20 questions on pharmacologic treatment were re-reviewed in addition to 26 new questions and recommendations.

Michael M. Ward, MD, chief of the Clinical Trials and Outcomes Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, said in an interview that the availability of new medications to treat axial spondyloarthritis (axSpA) prompted the updated guidelines.

“We took the opportunity to revisit some previous recommendations for which substantial new evidence was available, and also included new recommendations on some other topics, such as imaging,” said Dr. Ward, who is also first author of the new guidelines.

The panel that developed the questions focused on scenarios that a clinician would likely encounter in clinical practice, or situations in which how to manage a case is not clear. “Given this perspective, there were many questions that had limited evidence, but recommendations were made for all questions. For those questions that had less evidence in the literature, we relied more on the expertise of the panel,” Dr. Ward said.

The questions and recommendations for ankylosing spondylitis (AS) and nonradiographic axSpA centered around use of interleukin-17 (IL-17) inhibitors, tofacitinib (Xeljanz), and biosimilars of tumor necrosis factor-alpha inhibitors (TNFi), as well as when to taper and discontinue these medications.

Strong recommendations for patients with AS included using NSAIDs (low level of evidence), using TNFi when active disease remains despite NSAID treatment (high level of evidence), and using secukinumab (Cosentyx) or ixekizumab (Taltz) when active disease remains despite NSAID treatment over no treatment (high level of evidence). The guidelines also strongly recommend the use of physical therapy for adults with stable AS over no physical therapy (low level of evidence), as well as total hip arthroplasty in cases of advanced hip arthritis. The writing panel also strongly advised that adults with AS-related comorbidities should receive treatment by an ophthalmologist in cases of acute iritis. Strong recommendations were made against switching to a biosimilar of a TNFi after receiving treatment with an originator TNFi (regardless of whether it is for active or stable AS), use of systemic glucocorticoids in adults with active AS, treatment with spinal manipulation in patients with spinal fusion or advanced spinal osteoporosis, and screening for cardiac conduction defects and valvular heart disease with electrocardiograms.

Strong recommendations for nonradiographic axSpA were similar to those made for patients with AS, and the panel made strong recommendations for use of NSAIDs in patients with active disease; for TNFi treatment when NSAIDs fail; against switching to a biosimilar of a TNFi after starting the originator TNFi; against using systemic glucocorticoids; and in favor of using physical therapy rather than not.

The panel also made a number of conditional recommendations for AS and nonradiographic axSpA patients with regard to biologic preference and imaging. TNFis were conditionally recommended over secukinumab or ixekizumab in patients with active disease despite NSAIDs treatment, and in cases where a patient is not responding to a first TNFi treatment, the panel conditionally recommended secukinumab or ixekizumab over a second TNFi (very low evidence for all). Secukinumab or ixekizumab were also conditionally recommended over tofacitinib (very low evidence). Sulfasalazine, methotrexate, and tofacitinib were conditionally recommended in cases where patients had prominent peripheral arthritis or when TNFis are not available (very low to moderate evidence). The panel recommended against adding sulfasalazine or methotrexate to existing TNFi treatment (very low evidence), and they also advised against tapering as a standard treatment approach or discontinuing the biologic (very low evidence). MRI of the spine or pelvis was conditionally recommended to examine disease activity in unclear cases, but the panel recommended against ordering MRI scans to monitor disease inactivity (very low evidence).

“Most of the recommendations are conditional, primarily because of the relatively low level of evidence in the literature that addressed many of the questions,” while stronger recommendations came from larger clinical trials, Dr. Ward said. “The need for this update demonstrates the rapid progress in treatment that is occurring in axial spondyloarthritis, but the low level of evidence for many questions indicates that much more research is needed.”

Nine authors reported personal and institutional relationships in the form of consultancies, educational advisory board memberships, and site investigator appointments for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Galapagos, Janssen, Novartis, Pfizer, and UCB. The other authors reported no relevant conflicts of interest.

SOURCE: Ward MM et al. Arthritis Care Res. 2019 Aug 21. doi: 10.1002/acr.24025.

 

The American College of Rheumatology, Spondylitis Association of America, and Spondyloarthritis Research and Treatment Network have updated their guidelines on management of ankylosing spondylitis and nonradiographic axial spondyloarthritis.

Dr. Michael M. Ward

These guidelines serve as an update to the previous guidelines that were first published in 2015 (Arthritis Care Res. 2016;68:151–66). While the new guidelines did not review all recommendations from the 2015 guidelines, 20 questions on pharmacologic treatment were re-reviewed in addition to 26 new questions and recommendations.

Michael M. Ward, MD, chief of the Clinical Trials and Outcomes Branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, said in an interview that the availability of new medications to treat axial spondyloarthritis (axSpA) prompted the updated guidelines.

“We took the opportunity to revisit some previous recommendations for which substantial new evidence was available, and also included new recommendations on some other topics, such as imaging,” said Dr. Ward, who is also first author of the new guidelines.

The panel that developed the questions focused on scenarios that a clinician would likely encounter in clinical practice, or situations in which how to manage a case is not clear. “Given this perspective, there were many questions that had limited evidence, but recommendations were made for all questions. For those questions that had less evidence in the literature, we relied more on the expertise of the panel,” Dr. Ward said.

The questions and recommendations for ankylosing spondylitis (AS) and nonradiographic axSpA centered around use of interleukin-17 (IL-17) inhibitors, tofacitinib (Xeljanz), and biosimilars of tumor necrosis factor-alpha inhibitors (TNFi), as well as when to taper and discontinue these medications.

Strong recommendations for patients with AS included using NSAIDs (low level of evidence), using TNFi when active disease remains despite NSAID treatment (high level of evidence), and using secukinumab (Cosentyx) or ixekizumab (Taltz) when active disease remains despite NSAID treatment over no treatment (high level of evidence). The guidelines also strongly recommend the use of physical therapy for adults with stable AS over no physical therapy (low level of evidence), as well as total hip arthroplasty in cases of advanced hip arthritis. The writing panel also strongly advised that adults with AS-related comorbidities should receive treatment by an ophthalmologist in cases of acute iritis. Strong recommendations were made against switching to a biosimilar of a TNFi after receiving treatment with an originator TNFi (regardless of whether it is for active or stable AS), use of systemic glucocorticoids in adults with active AS, treatment with spinal manipulation in patients with spinal fusion or advanced spinal osteoporosis, and screening for cardiac conduction defects and valvular heart disease with electrocardiograms.

Strong recommendations for nonradiographic axSpA were similar to those made for patients with AS, and the panel made strong recommendations for use of NSAIDs in patients with active disease; for TNFi treatment when NSAIDs fail; against switching to a biosimilar of a TNFi after starting the originator TNFi; against using systemic glucocorticoids; and in favor of using physical therapy rather than not.

The panel also made a number of conditional recommendations for AS and nonradiographic axSpA patients with regard to biologic preference and imaging. TNFis were conditionally recommended over secukinumab or ixekizumab in patients with active disease despite NSAIDs treatment, and in cases where a patient is not responding to a first TNFi treatment, the panel conditionally recommended secukinumab or ixekizumab over a second TNFi (very low evidence for all). Secukinumab or ixekizumab were also conditionally recommended over tofacitinib (very low evidence). Sulfasalazine, methotrexate, and tofacitinib were conditionally recommended in cases where patients had prominent peripheral arthritis or when TNFis are not available (very low to moderate evidence). The panel recommended against adding sulfasalazine or methotrexate to existing TNFi treatment (very low evidence), and they also advised against tapering as a standard treatment approach or discontinuing the biologic (very low evidence). MRI of the spine or pelvis was conditionally recommended to examine disease activity in unclear cases, but the panel recommended against ordering MRI scans to monitor disease inactivity (very low evidence).

“Most of the recommendations are conditional, primarily because of the relatively low level of evidence in the literature that addressed many of the questions,” while stronger recommendations came from larger clinical trials, Dr. Ward said. “The need for this update demonstrates the rapid progress in treatment that is occurring in axial spondyloarthritis, but the low level of evidence for many questions indicates that much more research is needed.”

Nine authors reported personal and institutional relationships in the form of consultancies, educational advisory board memberships, and site investigator appointments for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Galapagos, Janssen, Novartis, Pfizer, and UCB. The other authors reported no relevant conflicts of interest.

SOURCE: Ward MM et al. Arthritis Care Res. 2019 Aug 21. doi: 10.1002/acr.24025.

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‘Recognizing Redness’

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The National Rosacea Society has released a booklet for patients called “Recognizing Redness” to help them assess their complexion before and after a rosacea flare or treatment, as well as better understand their disease, according to a release from the society. The booklet contains a redness register that lets patients compare their skin’s natural redness with that of areas affected by their rosacea; it also contains information about the disease, its diagnosis, and common triggers. The booklet is freely available on the society’s website www.rosacea.org/patients/recognizing-redness-patient-guide-rosacea. It can also be provided in bulk to health care providers and acquired directly by writing the National Rosacea Society, 196 James Street, Barrington, IL 60010, calling the society toll-free at 1-888-NO-BLUSH, or via e-mail at [email protected]. The new booklet was made possible by support from Aclaris.

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The National Rosacea Society has released a booklet for patients called “Recognizing Redness” to help them assess their complexion before and after a rosacea flare or treatment, as well as better understand their disease, according to a release from the society. The booklet contains a redness register that lets patients compare their skin’s natural redness with that of areas affected by their rosacea; it also contains information about the disease, its diagnosis, and common triggers. The booklet is freely available on the society’s website www.rosacea.org/patients/recognizing-redness-patient-guide-rosacea. It can also be provided in bulk to health care providers and acquired directly by writing the National Rosacea Society, 196 James Street, Barrington, IL 60010, calling the society toll-free at 1-888-NO-BLUSH, or via e-mail at [email protected]. The new booklet was made possible by support from Aclaris.

 

The National Rosacea Society has released a booklet for patients called “Recognizing Redness” to help them assess their complexion before and after a rosacea flare or treatment, as well as better understand their disease, according to a release from the society. The booklet contains a redness register that lets patients compare their skin’s natural redness with that of areas affected by their rosacea; it also contains information about the disease, its diagnosis, and common triggers. The booklet is freely available on the society’s website www.rosacea.org/patients/recognizing-redness-patient-guide-rosacea. It can also be provided in bulk to health care providers and acquired directly by writing the National Rosacea Society, 196 James Street, Barrington, IL 60010, calling the society toll-free at 1-888-NO-BLUSH, or via e-mail at [email protected]. The new booklet was made possible by support from Aclaris.

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Consider cyclosporine a go-to for refractory atopic dermatitis in kids

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– For children and adolescents with severe, refractory atopic dermatitis, Peter A. Lio, MD, often turns to cyclosporine as his systemic treatment of choice.

Doug Brunk/MDedge News
Dr. Peter A. Lio

Cyclosporine “works quickly, and it’s very reliable,” Dr. Lio said at the annual meeting of the Society for Pediatric Dermatology. “In my experience, more than 90% of patients will see significant improvement, but there are real risks, including hypertension, kidney damage, monthly blood work, tremor, hypertrichosis, gum hypertrophy, and cancer/infection risk.”

To mitigate those risks, Dr. Lio, of the departments of dermatology and pediatrics at Northwestern University, Chicago, prescribes cyclosporine for 3-6 months at a dose of 5 mg/kg per day with a cap of 300 mg per day to “to cool things down.” He then transitions patients to phototherapy or mycophenolate right away. “Those are my two favorites,” he said. “Methotrexate can also be used, but I rarely use azathioprine.

“If you do this, you avoid most of the major risks and you can put people in a remission. More than half of the time, maybe two-thirds of the time, I get them into at least a relative remission,” Dr. Lio said.

While patients are on cyclosporine, blood pressure should be monitored each week for 4 weeks, and then monthly, he said. Draws for complete blood count, liver function tests, comprehensive metabolic panel, uric acid, and lipids should be performed monthly for 3 months, then every 8 weeks, he advised. Dr. Lio typically maintains the cyclosporine for 3 months, then tapers patients off the drug.

Patients who continue to struggle for relief might try taking cyclosporine on weekends only, a concept reported by Spanish investigators in 2015 (Pediatr Dermatol 2015 32[4]:551-2). “This involves twice-daily full dosing just on Saturdays and Sundays,” Dr. Lio said. “I now have quite a few patients doing well with this approach.”

Dr. Lio disclosed having financial ties to numerous pharmaceutical companies but none related to cyclosporine.

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– For children and adolescents with severe, refractory atopic dermatitis, Peter A. Lio, MD, often turns to cyclosporine as his systemic treatment of choice.

Doug Brunk/MDedge News
Dr. Peter A. Lio

Cyclosporine “works quickly, and it’s very reliable,” Dr. Lio said at the annual meeting of the Society for Pediatric Dermatology. “In my experience, more than 90% of patients will see significant improvement, but there are real risks, including hypertension, kidney damage, monthly blood work, tremor, hypertrichosis, gum hypertrophy, and cancer/infection risk.”

To mitigate those risks, Dr. Lio, of the departments of dermatology and pediatrics at Northwestern University, Chicago, prescribes cyclosporine for 3-6 months at a dose of 5 mg/kg per day with a cap of 300 mg per day to “to cool things down.” He then transitions patients to phototherapy or mycophenolate right away. “Those are my two favorites,” he said. “Methotrexate can also be used, but I rarely use azathioprine.

“If you do this, you avoid most of the major risks and you can put people in a remission. More than half of the time, maybe two-thirds of the time, I get them into at least a relative remission,” Dr. Lio said.

While patients are on cyclosporine, blood pressure should be monitored each week for 4 weeks, and then monthly, he said. Draws for complete blood count, liver function tests, comprehensive metabolic panel, uric acid, and lipids should be performed monthly for 3 months, then every 8 weeks, he advised. Dr. Lio typically maintains the cyclosporine for 3 months, then tapers patients off the drug.

Patients who continue to struggle for relief might try taking cyclosporine on weekends only, a concept reported by Spanish investigators in 2015 (Pediatr Dermatol 2015 32[4]:551-2). “This involves twice-daily full dosing just on Saturdays and Sundays,” Dr. Lio said. “I now have quite a few patients doing well with this approach.”

Dr. Lio disclosed having financial ties to numerous pharmaceutical companies but none related to cyclosporine.

 

– For children and adolescents with severe, refractory atopic dermatitis, Peter A. Lio, MD, often turns to cyclosporine as his systemic treatment of choice.

Doug Brunk/MDedge News
Dr. Peter A. Lio

Cyclosporine “works quickly, and it’s very reliable,” Dr. Lio said at the annual meeting of the Society for Pediatric Dermatology. “In my experience, more than 90% of patients will see significant improvement, but there are real risks, including hypertension, kidney damage, monthly blood work, tremor, hypertrichosis, gum hypertrophy, and cancer/infection risk.”

To mitigate those risks, Dr. Lio, of the departments of dermatology and pediatrics at Northwestern University, Chicago, prescribes cyclosporine for 3-6 months at a dose of 5 mg/kg per day with a cap of 300 mg per day to “to cool things down.” He then transitions patients to phototherapy or mycophenolate right away. “Those are my two favorites,” he said. “Methotrexate can also be used, but I rarely use azathioprine.

“If you do this, you avoid most of the major risks and you can put people in a remission. More than half of the time, maybe two-thirds of the time, I get them into at least a relative remission,” Dr. Lio said.

While patients are on cyclosporine, blood pressure should be monitored each week for 4 weeks, and then monthly, he said. Draws for complete blood count, liver function tests, comprehensive metabolic panel, uric acid, and lipids should be performed monthly for 3 months, then every 8 weeks, he advised. Dr. Lio typically maintains the cyclosporine for 3 months, then tapers patients off the drug.

Patients who continue to struggle for relief might try taking cyclosporine on weekends only, a concept reported by Spanish investigators in 2015 (Pediatr Dermatol 2015 32[4]:551-2). “This involves twice-daily full dosing just on Saturdays and Sundays,” Dr. Lio said. “I now have quite a few patients doing well with this approach.”

Dr. Lio disclosed having financial ties to numerous pharmaceutical companies but none related to cyclosporine.

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Minimally invasive surgery for cervical cancer: Is surgeon volume a factor?

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The role of minimally invasive surgery for early-stage cervical cancer has been the subject of heated debate since the presentation of the results of the Laparoscopic Approach to Cervical Cancer (LACC) Trial at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in 2018. This was an international, randomized, phase 3 trial comparing minimally invasive radical hysterectomy (MH) to open radical hysterectomy (OH) in the treatment of early-stage cervical cancer. The trial was closed early by the study’s Data and Safety Monitoring Committee due to an imbalance of deaths between the groups, with a higher rate in the minimally invasive arm. The final results, which were largely unexpected by the medical community, showed that the disease-free survival (DFS) at 4.5 years was 86.0% in the MH arm and 96.5% in the OH arm, which was a larger difference than their noninferiority cutoff of -7.2 percentage points.1 Results of an epidemiologic study, which used data from the Surveillance, Epidemiology, and End Results (SEER) program and the National Cancer Database, also were presented at this meeting, and they reinforced the findings of the LACC trial.2

The combined results have caused significant concern and confusion from the medical community regarding the clinical implication that minimally invasive surgery may be an unacceptable approach for radical hysterectomy in cervical cancer. Prior to this study, retrospective data supported similar outcomes between the two approaches.3 Additionally, robotic surgery has made radical hysterectomy an option for those with a higher body mass index, as an open radical hysterectomy can be technically challenging in larger patients and result in a higher rate of adverse outcomes.

LACC trial questioned by US surgeons

Many in the United States have questioned the design and conclusions of the LACC trial. This trial was conducted primarily outside of North America and utilized conventional laparoscopic surgery 85% of the time as opposed to robotic surgery. Additionally, the found difference in DFS between MH and OH may have been driven more by the superior performance of the OH group (compared with historical data) than the poorly performing MH group.4 Other criticisms have touched on the low number of overall survival events, the low bar for surgeon volume or skill assessment, and the inability to make conclusions regarding “low-risk” lesions (<2 cm, no lymphovascular space invasion, <1 cm depth of invasion).

Were requirements for surgical skill adequate? Regarding surgeon skill, the LACC trial required documentation of the perioperative outcomes from 10 laparoscopic or robotic radical hysterectomies, as well as 2 unedited videos of each surgeon participating in the study to verify their technique, which some have considered inadequate to sufficiently vet a surgeon’s ability. Additionally, 14 of the 33 centers enrolled in the study accrued 71% of the patients, and concerns about the surgeon volume of the remaining 19 centers have been raised. Finally, there has been discussion about whether the variance in surgical approach can even be adequately assessed in a trial of this nature, as surgical skill is not a binary variable that is easily amenable to randomization. Unlike other trials, which have clear exposure and control arms, no 2 surgeries are exactly alike, and surgical technique is highly variable between surgeons, institutions, and countries.

Continue to: New data evaluate for surgeon volume

 

 

New data evaluate for surgeon volume

In an effort to address the concerns regarding surgical approach and expertise, the recently published study by Cusimano and colleagues uses population-based data from Ontario for all women undergoing radical hysterectomy for cervical cancer over a 10-year period from 2006 through 2016.5 The primary outcome was all-cause death, but the study also sought to address whether surgeon volume has an impact on recurrence rates for patients undergoing MH versus OH. To measure this impact the authors stratified surgeon characteristics by technique-specific volume and cervical cancer volume, splitting these volumes at the 50% percentile for low- and high-volume surgeons. They defined technique-specific volume as the number of simple and radical hysterectomies performed in the prior year using the selected approach (MH or OH). Cervical cancer volume was calculated as the number of hysterectomies of any type for cervical cancer in the previous 2 years. The technique-specific volume variable was subsequently re-categorized into tertiles, examined as a continuous variable, and analyzed at the 50th percentile for each year of the study.

Death and recurrence rates better in the OH group. The final cohort included 958 women that were relatively evenly split between MH and OH procedures. Results from their analysis show no difference in terms of all-cause death, cervical cancer–specific death, or recurrence. However, all 3 of these parameters were significantly different in favor of the OH group in women with Stage IB disease, which comprised over half of the overall cohort. Importantly, neither technique-specific volume nor cervical cancer volume had an effect on death or recurrence in Stage IB patients in any of the investigators’ analyses.

Important limitations. There are several limitations to this study that have to be taken into account before drawing any conclusions. Pathologic data were obtained from the database and did not include some important details about the tumor specimens (including specifying subgroups of Stage IA and IB disease, tumor size, presence of lymphovascular space invasion, and depth of stromal invasion). All of these details have been shown to be important prognostic variables in early-stage cervical cancer. Additionally, the MH group included a predominantly laparoscopic approach with only 10% of cases performed robotically, which again brings into question the generalizability of the data.

However, despite some of these shortcomings, the study authors do make a compelling argument that surgeon volume alone does not seem to play a significant role in cancer outcomes after MH.

 

With surgical approaches hard to compare, turn to careful patient counseling

Definitive assessment of the impact of surgical skill and experience on cervical cancer outcomes is probably an impossible task, as even a perfectly designed trial cannot entirely account for the intricacies of a complex surgical procedure. Variations in tumor characteristics and patient anatomy that affect operative decision making are not likely to be reflected when a patient’s outcome is plugged into a database. As a result, some surgeons and departments have turned to reporting personal or institutional recurrence rates for MH, which they believe may be a better representation of a patient’s risk in their hands. Meanwhile, many surgeons and groups have stopped performing MH altogether, largely due to the results of the LACC trial. Irrespective of final surgical route, it is important that the risks and benefits of both minimally invasive and open approaches be adequately discussed with patients so that they can make informed decisions regarding their own medical care.

References
  1. Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904. 
  2. Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. 2018;379:1905-1914. 
  3. Wang Y, Deng L, Cao L, et al. The outcome of laparoscopy versus laparotomy for the management of early stage cervical cancer-meta analysis. J Minim Invasive Gynecol. 2015;22:S4-S5. 
  4. Leitao MM Jr. The LACC Trial: has minimally invasive surgery for early-stage cervical cancer been dealt a knockout punch? Int J Gynecol Cancer. 2018;28:1248-1250. 
  5. Cusimano MC, Baxter NN, Gien LT, et al. Impact of surgical approach on oncologic outcomes in women undergoing radical hysterectomy for cervical cancer. Am J Obstet Gynecol. July 6, 2019. doi:10.1016/j.ajog.2019.07.009. 
     
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Dr. Huh is Division Director and Professor, Division of Gynecologic Oncology, Margaret Cameron Spain Endowed Chair in Obstetrics/Gynecology, University of Alabama at Birmingham.

The authors report no financial relationships relevant to this article.

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Article PDF

The role of minimally invasive surgery for early-stage cervical cancer has been the subject of heated debate since the presentation of the results of the Laparoscopic Approach to Cervical Cancer (LACC) Trial at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in 2018. This was an international, randomized, phase 3 trial comparing minimally invasive radical hysterectomy (MH) to open radical hysterectomy (OH) in the treatment of early-stage cervical cancer. The trial was closed early by the study’s Data and Safety Monitoring Committee due to an imbalance of deaths between the groups, with a higher rate in the minimally invasive arm. The final results, which were largely unexpected by the medical community, showed that the disease-free survival (DFS) at 4.5 years was 86.0% in the MH arm and 96.5% in the OH arm, which was a larger difference than their noninferiority cutoff of -7.2 percentage points.1 Results of an epidemiologic study, which used data from the Surveillance, Epidemiology, and End Results (SEER) program and the National Cancer Database, also were presented at this meeting, and they reinforced the findings of the LACC trial.2

The combined results have caused significant concern and confusion from the medical community regarding the clinical implication that minimally invasive surgery may be an unacceptable approach for radical hysterectomy in cervical cancer. Prior to this study, retrospective data supported similar outcomes between the two approaches.3 Additionally, robotic surgery has made radical hysterectomy an option for those with a higher body mass index, as an open radical hysterectomy can be technically challenging in larger patients and result in a higher rate of adverse outcomes.

LACC trial questioned by US surgeons

Many in the United States have questioned the design and conclusions of the LACC trial. This trial was conducted primarily outside of North America and utilized conventional laparoscopic surgery 85% of the time as opposed to robotic surgery. Additionally, the found difference in DFS between MH and OH may have been driven more by the superior performance of the OH group (compared with historical data) than the poorly performing MH group.4 Other criticisms have touched on the low number of overall survival events, the low bar for surgeon volume or skill assessment, and the inability to make conclusions regarding “low-risk” lesions (<2 cm, no lymphovascular space invasion, <1 cm depth of invasion).

Were requirements for surgical skill adequate? Regarding surgeon skill, the LACC trial required documentation of the perioperative outcomes from 10 laparoscopic or robotic radical hysterectomies, as well as 2 unedited videos of each surgeon participating in the study to verify their technique, which some have considered inadequate to sufficiently vet a surgeon’s ability. Additionally, 14 of the 33 centers enrolled in the study accrued 71% of the patients, and concerns about the surgeon volume of the remaining 19 centers have been raised. Finally, there has been discussion about whether the variance in surgical approach can even be adequately assessed in a trial of this nature, as surgical skill is not a binary variable that is easily amenable to randomization. Unlike other trials, which have clear exposure and control arms, no 2 surgeries are exactly alike, and surgical technique is highly variable between surgeons, institutions, and countries.

Continue to: New data evaluate for surgeon volume

 

 

New data evaluate for surgeon volume

In an effort to address the concerns regarding surgical approach and expertise, the recently published study by Cusimano and colleagues uses population-based data from Ontario for all women undergoing radical hysterectomy for cervical cancer over a 10-year period from 2006 through 2016.5 The primary outcome was all-cause death, but the study also sought to address whether surgeon volume has an impact on recurrence rates for patients undergoing MH versus OH. To measure this impact the authors stratified surgeon characteristics by technique-specific volume and cervical cancer volume, splitting these volumes at the 50% percentile for low- and high-volume surgeons. They defined technique-specific volume as the number of simple and radical hysterectomies performed in the prior year using the selected approach (MH or OH). Cervical cancer volume was calculated as the number of hysterectomies of any type for cervical cancer in the previous 2 years. The technique-specific volume variable was subsequently re-categorized into tertiles, examined as a continuous variable, and analyzed at the 50th percentile for each year of the study.

Death and recurrence rates better in the OH group. The final cohort included 958 women that were relatively evenly split between MH and OH procedures. Results from their analysis show no difference in terms of all-cause death, cervical cancer–specific death, or recurrence. However, all 3 of these parameters were significantly different in favor of the OH group in women with Stage IB disease, which comprised over half of the overall cohort. Importantly, neither technique-specific volume nor cervical cancer volume had an effect on death or recurrence in Stage IB patients in any of the investigators’ analyses.

Important limitations. There are several limitations to this study that have to be taken into account before drawing any conclusions. Pathologic data were obtained from the database and did not include some important details about the tumor specimens (including specifying subgroups of Stage IA and IB disease, tumor size, presence of lymphovascular space invasion, and depth of stromal invasion). All of these details have been shown to be important prognostic variables in early-stage cervical cancer. Additionally, the MH group included a predominantly laparoscopic approach with only 10% of cases performed robotically, which again brings into question the generalizability of the data.

However, despite some of these shortcomings, the study authors do make a compelling argument that surgeon volume alone does not seem to play a significant role in cancer outcomes after MH.

 

With surgical approaches hard to compare, turn to careful patient counseling

Definitive assessment of the impact of surgical skill and experience on cervical cancer outcomes is probably an impossible task, as even a perfectly designed trial cannot entirely account for the intricacies of a complex surgical procedure. Variations in tumor characteristics and patient anatomy that affect operative decision making are not likely to be reflected when a patient’s outcome is plugged into a database. As a result, some surgeons and departments have turned to reporting personal or institutional recurrence rates for MH, which they believe may be a better representation of a patient’s risk in their hands. Meanwhile, many surgeons and groups have stopped performing MH altogether, largely due to the results of the LACC trial. Irrespective of final surgical route, it is important that the risks and benefits of both minimally invasive and open approaches be adequately discussed with patients so that they can make informed decisions regarding their own medical care.

The role of minimally invasive surgery for early-stage cervical cancer has been the subject of heated debate since the presentation of the results of the Laparoscopic Approach to Cervical Cancer (LACC) Trial at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in 2018. This was an international, randomized, phase 3 trial comparing minimally invasive radical hysterectomy (MH) to open radical hysterectomy (OH) in the treatment of early-stage cervical cancer. The trial was closed early by the study’s Data and Safety Monitoring Committee due to an imbalance of deaths between the groups, with a higher rate in the minimally invasive arm. The final results, which were largely unexpected by the medical community, showed that the disease-free survival (DFS) at 4.5 years was 86.0% in the MH arm and 96.5% in the OH arm, which was a larger difference than their noninferiority cutoff of -7.2 percentage points.1 Results of an epidemiologic study, which used data from the Surveillance, Epidemiology, and End Results (SEER) program and the National Cancer Database, also were presented at this meeting, and they reinforced the findings of the LACC trial.2

The combined results have caused significant concern and confusion from the medical community regarding the clinical implication that minimally invasive surgery may be an unacceptable approach for radical hysterectomy in cervical cancer. Prior to this study, retrospective data supported similar outcomes between the two approaches.3 Additionally, robotic surgery has made radical hysterectomy an option for those with a higher body mass index, as an open radical hysterectomy can be technically challenging in larger patients and result in a higher rate of adverse outcomes.

LACC trial questioned by US surgeons

Many in the United States have questioned the design and conclusions of the LACC trial. This trial was conducted primarily outside of North America and utilized conventional laparoscopic surgery 85% of the time as opposed to robotic surgery. Additionally, the found difference in DFS between MH and OH may have been driven more by the superior performance of the OH group (compared with historical data) than the poorly performing MH group.4 Other criticisms have touched on the low number of overall survival events, the low bar for surgeon volume or skill assessment, and the inability to make conclusions regarding “low-risk” lesions (<2 cm, no lymphovascular space invasion, <1 cm depth of invasion).

Were requirements for surgical skill adequate? Regarding surgeon skill, the LACC trial required documentation of the perioperative outcomes from 10 laparoscopic or robotic radical hysterectomies, as well as 2 unedited videos of each surgeon participating in the study to verify their technique, which some have considered inadequate to sufficiently vet a surgeon’s ability. Additionally, 14 of the 33 centers enrolled in the study accrued 71% of the patients, and concerns about the surgeon volume of the remaining 19 centers have been raised. Finally, there has been discussion about whether the variance in surgical approach can even be adequately assessed in a trial of this nature, as surgical skill is not a binary variable that is easily amenable to randomization. Unlike other trials, which have clear exposure and control arms, no 2 surgeries are exactly alike, and surgical technique is highly variable between surgeons, institutions, and countries.

Continue to: New data evaluate for surgeon volume

 

 

New data evaluate for surgeon volume

In an effort to address the concerns regarding surgical approach and expertise, the recently published study by Cusimano and colleagues uses population-based data from Ontario for all women undergoing radical hysterectomy for cervical cancer over a 10-year period from 2006 through 2016.5 The primary outcome was all-cause death, but the study also sought to address whether surgeon volume has an impact on recurrence rates for patients undergoing MH versus OH. To measure this impact the authors stratified surgeon characteristics by technique-specific volume and cervical cancer volume, splitting these volumes at the 50% percentile for low- and high-volume surgeons. They defined technique-specific volume as the number of simple and radical hysterectomies performed in the prior year using the selected approach (MH or OH). Cervical cancer volume was calculated as the number of hysterectomies of any type for cervical cancer in the previous 2 years. The technique-specific volume variable was subsequently re-categorized into tertiles, examined as a continuous variable, and analyzed at the 50th percentile for each year of the study.

Death and recurrence rates better in the OH group. The final cohort included 958 women that were relatively evenly split between MH and OH procedures. Results from their analysis show no difference in terms of all-cause death, cervical cancer–specific death, or recurrence. However, all 3 of these parameters were significantly different in favor of the OH group in women with Stage IB disease, which comprised over half of the overall cohort. Importantly, neither technique-specific volume nor cervical cancer volume had an effect on death or recurrence in Stage IB patients in any of the investigators’ analyses.

Important limitations. There are several limitations to this study that have to be taken into account before drawing any conclusions. Pathologic data were obtained from the database and did not include some important details about the tumor specimens (including specifying subgroups of Stage IA and IB disease, tumor size, presence of lymphovascular space invasion, and depth of stromal invasion). All of these details have been shown to be important prognostic variables in early-stage cervical cancer. Additionally, the MH group included a predominantly laparoscopic approach with only 10% of cases performed robotically, which again brings into question the generalizability of the data.

However, despite some of these shortcomings, the study authors do make a compelling argument that surgeon volume alone does not seem to play a significant role in cancer outcomes after MH.

 

With surgical approaches hard to compare, turn to careful patient counseling

Definitive assessment of the impact of surgical skill and experience on cervical cancer outcomes is probably an impossible task, as even a perfectly designed trial cannot entirely account for the intricacies of a complex surgical procedure. Variations in tumor characteristics and patient anatomy that affect operative decision making are not likely to be reflected when a patient’s outcome is plugged into a database. As a result, some surgeons and departments have turned to reporting personal or institutional recurrence rates for MH, which they believe may be a better representation of a patient’s risk in their hands. Meanwhile, many surgeons and groups have stopped performing MH altogether, largely due to the results of the LACC trial. Irrespective of final surgical route, it is important that the risks and benefits of both minimally invasive and open approaches be adequately discussed with patients so that they can make informed decisions regarding their own medical care.

References
  1. Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904. 
  2. Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. 2018;379:1905-1914. 
  3. Wang Y, Deng L, Cao L, et al. The outcome of laparoscopy versus laparotomy for the management of early stage cervical cancer-meta analysis. J Minim Invasive Gynecol. 2015;22:S4-S5. 
  4. Leitao MM Jr. The LACC Trial: has minimally invasive surgery for early-stage cervical cancer been dealt a knockout punch? Int J Gynecol Cancer. 2018;28:1248-1250. 
  5. Cusimano MC, Baxter NN, Gien LT, et al. Impact of surgical approach on oncologic outcomes in women undergoing radical hysterectomy for cervical cancer. Am J Obstet Gynecol. July 6, 2019. doi:10.1016/j.ajog.2019.07.009. 
     
References
  1. Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904. 
  2. Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. 2018;379:1905-1914. 
  3. Wang Y, Deng L, Cao L, et al. The outcome of laparoscopy versus laparotomy for the management of early stage cervical cancer-meta analysis. J Minim Invasive Gynecol. 2015;22:S4-S5. 
  4. Leitao MM Jr. The LACC Trial: has minimally invasive surgery for early-stage cervical cancer been dealt a knockout punch? Int J Gynecol Cancer. 2018;28:1248-1250. 
  5. Cusimano MC, Baxter NN, Gien LT, et al. Impact of surgical approach on oncologic outcomes in women undergoing radical hysterectomy for cervical cancer. Am J Obstet Gynecol. July 6, 2019. doi:10.1016/j.ajog.2019.07.009. 
     
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Protons safe, effective for breast cancer control

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In women with nonmetastatic breast cancer, postoperative regional node irradiation with proton-beam radiation was associated with low rates of toxicity and with disease control rates similar to those reported with conventional photon-based radiation therapy (RT), investigators in a small prospective clinical study reported.

Among 62 survivors of a cohort of 69 women with nonmetastatic breast cancer who required postoperative radiation to the internal mammary nodes (IMN) and for whom conventional radiation was thought to pose excess risks of toxicity, there were no cases of the primary endpoint of grade 3 or greater radiation pneumonitis and no grade 4 toxicities within 3 months of therapy, reported Rachel B. Jimenez, MD, of the Massachusetts General Hospital Cancer Center in Boston and colleagues.

“In our prospective trial of women with locally advanced breast cancer who required treatment of the IMNs, proton beam RT was safe and effective. Future research will provide needed information about the potential long-term normal tissue–sparing benefits of this complex treatment modality compared with conventional radiation,” they wrote in the Journal of Clinical Oncology.

Protons offer the theoretic advantage over photons of minimizing radiation dose to the heart and lungs when treating the breast, chest wall, or regional lymph nodes. Protons, unlike photons, deliver their maximum ionizing energy to tissues immediately before they come to rest, allowing for a more precise dose of radiation to local tissues.

“Multiple dosimetric planning studies that compared proton RT with photon RT have demonstrated superior delivery to targeted areas while sparing more of the heart and lungs. However, prospective clinical data are lacking to support the safety and efficacy of proton RT for breast cancer,” the investigators wrote.

To rectify this, they enrolled adult patients with nonmetastatic breast cancer who required postoperative radiation therapy inclusive of the IMNs and for whom the treating physician determined that either breast reconstruction would prevent adequate target coverage or conventional radiation would deliver 20 Gy or more to 5% or more of the heart and/or the left anterior descending artery (LAD).

A total of 69 patients (median age 45 years) were evaluable for the primary endpoint. In all, 63 of the 70 enrolled patients had left-sided breast cancer, 5 had right-sided breast cancer, and 2 had bilateral breast cancer. The majority of patients (65) had stage II-III disease. All but 2 patients underwent systemic chemotherapy, and 50 underwent immediate reconstruction.

The median of the mean proton radiation dose to the chest wall/breast was 49.7 Gy (relative biological effectiveness) and to the IMN was 48.8 Gy (relative biological effectiveness), indicating comprehensive coverage. The mean heart dose was a median of 0.50 Gy, and the mean dose to the LAD was a median of 1.16 Gy.

After a median follow-up of 55 months, the 5-year rate for locoregional failure among 62 surviving patients was 1.5%

As noted before, there were no cases of grade 3 radiation pneumonitis and no grade 4 toxicities of any type within 3 months of radiation therapy. One patient developed grade 2 radiation pneumonitis 4 months after therapy and was successfully treated with oral corticosteroids, and one developed a severe infection of the bilateral chest wall 4 months after radiation to the left-side chest wall. She was treated with intravenous antibiotics.

There were no significant changes in either echocardiography or cardiac biomarkers after radiotherapy.

The authors noted that the toxicity and disease control rates compared favorably with those of historical data on conventional radiation therapy from two studies published in 2015 (N Engl J Med. 2015;373:307-16; N Engl J Med. 2015;373:317-27).

The study was supported by a grant from the National Institutes of Health. Dr. Jimenez disclosed research funding from Focal Therapeutics.

SOURCE: Jimenez RB et al. J Clin Oncol 2019 Aug 26. doi: 10.1200/JCO.18.02366.

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In women with nonmetastatic breast cancer, postoperative regional node irradiation with proton-beam radiation was associated with low rates of toxicity and with disease control rates similar to those reported with conventional photon-based radiation therapy (RT), investigators in a small prospective clinical study reported.

Among 62 survivors of a cohort of 69 women with nonmetastatic breast cancer who required postoperative radiation to the internal mammary nodes (IMN) and for whom conventional radiation was thought to pose excess risks of toxicity, there were no cases of the primary endpoint of grade 3 or greater radiation pneumonitis and no grade 4 toxicities within 3 months of therapy, reported Rachel B. Jimenez, MD, of the Massachusetts General Hospital Cancer Center in Boston and colleagues.

“In our prospective trial of women with locally advanced breast cancer who required treatment of the IMNs, proton beam RT was safe and effective. Future research will provide needed information about the potential long-term normal tissue–sparing benefits of this complex treatment modality compared with conventional radiation,” they wrote in the Journal of Clinical Oncology.

Protons offer the theoretic advantage over photons of minimizing radiation dose to the heart and lungs when treating the breast, chest wall, or regional lymph nodes. Protons, unlike photons, deliver their maximum ionizing energy to tissues immediately before they come to rest, allowing for a more precise dose of radiation to local tissues.

“Multiple dosimetric planning studies that compared proton RT with photon RT have demonstrated superior delivery to targeted areas while sparing more of the heart and lungs. However, prospective clinical data are lacking to support the safety and efficacy of proton RT for breast cancer,” the investigators wrote.

To rectify this, they enrolled adult patients with nonmetastatic breast cancer who required postoperative radiation therapy inclusive of the IMNs and for whom the treating physician determined that either breast reconstruction would prevent adequate target coverage or conventional radiation would deliver 20 Gy or more to 5% or more of the heart and/or the left anterior descending artery (LAD).

A total of 69 patients (median age 45 years) were evaluable for the primary endpoint. In all, 63 of the 70 enrolled patients had left-sided breast cancer, 5 had right-sided breast cancer, and 2 had bilateral breast cancer. The majority of patients (65) had stage II-III disease. All but 2 patients underwent systemic chemotherapy, and 50 underwent immediate reconstruction.

The median of the mean proton radiation dose to the chest wall/breast was 49.7 Gy (relative biological effectiveness) and to the IMN was 48.8 Gy (relative biological effectiveness), indicating comprehensive coverage. The mean heart dose was a median of 0.50 Gy, and the mean dose to the LAD was a median of 1.16 Gy.

After a median follow-up of 55 months, the 5-year rate for locoregional failure among 62 surviving patients was 1.5%

As noted before, there were no cases of grade 3 radiation pneumonitis and no grade 4 toxicities of any type within 3 months of radiation therapy. One patient developed grade 2 radiation pneumonitis 4 months after therapy and was successfully treated with oral corticosteroids, and one developed a severe infection of the bilateral chest wall 4 months after radiation to the left-side chest wall. She was treated with intravenous antibiotics.

There were no significant changes in either echocardiography or cardiac biomarkers after radiotherapy.

The authors noted that the toxicity and disease control rates compared favorably with those of historical data on conventional radiation therapy from two studies published in 2015 (N Engl J Med. 2015;373:307-16; N Engl J Med. 2015;373:317-27).

The study was supported by a grant from the National Institutes of Health. Dr. Jimenez disclosed research funding from Focal Therapeutics.

SOURCE: Jimenez RB et al. J Clin Oncol 2019 Aug 26. doi: 10.1200/JCO.18.02366.

 

In women with nonmetastatic breast cancer, postoperative regional node irradiation with proton-beam radiation was associated with low rates of toxicity and with disease control rates similar to those reported with conventional photon-based radiation therapy (RT), investigators in a small prospective clinical study reported.

Among 62 survivors of a cohort of 69 women with nonmetastatic breast cancer who required postoperative radiation to the internal mammary nodes (IMN) and for whom conventional radiation was thought to pose excess risks of toxicity, there were no cases of the primary endpoint of grade 3 or greater radiation pneumonitis and no grade 4 toxicities within 3 months of therapy, reported Rachel B. Jimenez, MD, of the Massachusetts General Hospital Cancer Center in Boston and colleagues.

“In our prospective trial of women with locally advanced breast cancer who required treatment of the IMNs, proton beam RT was safe and effective. Future research will provide needed information about the potential long-term normal tissue–sparing benefits of this complex treatment modality compared with conventional radiation,” they wrote in the Journal of Clinical Oncology.

Protons offer the theoretic advantage over photons of minimizing radiation dose to the heart and lungs when treating the breast, chest wall, or regional lymph nodes. Protons, unlike photons, deliver their maximum ionizing energy to tissues immediately before they come to rest, allowing for a more precise dose of radiation to local tissues.

“Multiple dosimetric planning studies that compared proton RT with photon RT have demonstrated superior delivery to targeted areas while sparing more of the heart and lungs. However, prospective clinical data are lacking to support the safety and efficacy of proton RT for breast cancer,” the investigators wrote.

To rectify this, they enrolled adult patients with nonmetastatic breast cancer who required postoperative radiation therapy inclusive of the IMNs and for whom the treating physician determined that either breast reconstruction would prevent adequate target coverage or conventional radiation would deliver 20 Gy or more to 5% or more of the heart and/or the left anterior descending artery (LAD).

A total of 69 patients (median age 45 years) were evaluable for the primary endpoint. In all, 63 of the 70 enrolled patients had left-sided breast cancer, 5 had right-sided breast cancer, and 2 had bilateral breast cancer. The majority of patients (65) had stage II-III disease. All but 2 patients underwent systemic chemotherapy, and 50 underwent immediate reconstruction.

The median of the mean proton radiation dose to the chest wall/breast was 49.7 Gy (relative biological effectiveness) and to the IMN was 48.8 Gy (relative biological effectiveness), indicating comprehensive coverage. The mean heart dose was a median of 0.50 Gy, and the mean dose to the LAD was a median of 1.16 Gy.

After a median follow-up of 55 months, the 5-year rate for locoregional failure among 62 surviving patients was 1.5%

As noted before, there were no cases of grade 3 radiation pneumonitis and no grade 4 toxicities of any type within 3 months of radiation therapy. One patient developed grade 2 radiation pneumonitis 4 months after therapy and was successfully treated with oral corticosteroids, and one developed a severe infection of the bilateral chest wall 4 months after radiation to the left-side chest wall. She was treated with intravenous antibiotics.

There were no significant changes in either echocardiography or cardiac biomarkers after radiotherapy.

The authors noted that the toxicity and disease control rates compared favorably with those of historical data on conventional radiation therapy from two studies published in 2015 (N Engl J Med. 2015;373:307-16; N Engl J Med. 2015;373:317-27).

The study was supported by a grant from the National Institutes of Health. Dr. Jimenez disclosed research funding from Focal Therapeutics.

SOURCE: Jimenez RB et al. J Clin Oncol 2019 Aug 26. doi: 10.1200/JCO.18.02366.

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Productivity-based salary structure not associated with value-based culture

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Background: Although new payment models have been implemented by the Centers for Medicare & Medicaid Services (CMS) for hospital reimbursement, little is known about the effects of reimbursement models on the culture of providing value-based care among individual hospitalists. The concern is that productivity-based models increase pressure on hospitalists to maximize volume and billing, as opposed to focusing on value.



Study design: Observational, cross-sectional, survey-based study.

Setting: A total of 12 hospitals in California, which represented university, community, and safety-net settings.

Synopsis: Hospitalists were asked to complete the High-Value Care Culture Survey (HVCCS), a validated tool that assesses value-based decision making. Components of the survey assessed leadership and health system messaging, data transparency and access, comfort with cost conversations, and blame-free environments. Hospitalists were also asked to self-report their reimbursement structure: salary alone, salary plus productivity, or salary plus value-based adjustments.

A total of 255 hospitalists completed the survey. The mean HVCCS score was 50.2 on a 0-100 scale. Hospitalists who reported reimbursement with salary plus productivity adjustments had a lower mean HVCCS score (beta = –6.2; 95% confidence interval, –9.9 to –2.5) when compared with hospitalists paid with salary alone. An association was not found between HVCCS score and reimbursement with salary plus value-based adjustments when compared with salary alone, though this finding may have been limited by sample size.

Bottom line: A hospitalist reimbursement model of salary plus productivity was associated with lower measures of value-based care culture.

Citation: Gupta R et al. Association between hospitalist productivity payments and high-value care culture. J Hosp Med. 2019;14(1):16-21.

Dr. Huang is a physician adviser and associate clinical professor in the division of hospital medicine at the University of California, San Diego.

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Background: Although new payment models have been implemented by the Centers for Medicare & Medicaid Services (CMS) for hospital reimbursement, little is known about the effects of reimbursement models on the culture of providing value-based care among individual hospitalists. The concern is that productivity-based models increase pressure on hospitalists to maximize volume and billing, as opposed to focusing on value.



Study design: Observational, cross-sectional, survey-based study.

Setting: A total of 12 hospitals in California, which represented university, community, and safety-net settings.

Synopsis: Hospitalists were asked to complete the High-Value Care Culture Survey (HVCCS), a validated tool that assesses value-based decision making. Components of the survey assessed leadership and health system messaging, data transparency and access, comfort with cost conversations, and blame-free environments. Hospitalists were also asked to self-report their reimbursement structure: salary alone, salary plus productivity, or salary plus value-based adjustments.

A total of 255 hospitalists completed the survey. The mean HVCCS score was 50.2 on a 0-100 scale. Hospitalists who reported reimbursement with salary plus productivity adjustments had a lower mean HVCCS score (beta = –6.2; 95% confidence interval, –9.9 to –2.5) when compared with hospitalists paid with salary alone. An association was not found between HVCCS score and reimbursement with salary plus value-based adjustments when compared with salary alone, though this finding may have been limited by sample size.

Bottom line: A hospitalist reimbursement model of salary plus productivity was associated with lower measures of value-based care culture.

Citation: Gupta R et al. Association between hospitalist productivity payments and high-value care culture. J Hosp Med. 2019;14(1):16-21.

Dr. Huang is a physician adviser and associate clinical professor in the division of hospital medicine at the University of California, San Diego.

Background: Although new payment models have been implemented by the Centers for Medicare & Medicaid Services (CMS) for hospital reimbursement, little is known about the effects of reimbursement models on the culture of providing value-based care among individual hospitalists. The concern is that productivity-based models increase pressure on hospitalists to maximize volume and billing, as opposed to focusing on value.



Study design: Observational, cross-sectional, survey-based study.

Setting: A total of 12 hospitals in California, which represented university, community, and safety-net settings.

Synopsis: Hospitalists were asked to complete the High-Value Care Culture Survey (HVCCS), a validated tool that assesses value-based decision making. Components of the survey assessed leadership and health system messaging, data transparency and access, comfort with cost conversations, and blame-free environments. Hospitalists were also asked to self-report their reimbursement structure: salary alone, salary plus productivity, or salary plus value-based adjustments.

A total of 255 hospitalists completed the survey. The mean HVCCS score was 50.2 on a 0-100 scale. Hospitalists who reported reimbursement with salary plus productivity adjustments had a lower mean HVCCS score (beta = –6.2; 95% confidence interval, –9.9 to –2.5) when compared with hospitalists paid with salary alone. An association was not found between HVCCS score and reimbursement with salary plus value-based adjustments when compared with salary alone, though this finding may have been limited by sample size.

Bottom line: A hospitalist reimbursement model of salary plus productivity was associated with lower measures of value-based care culture.

Citation: Gupta R et al. Association between hospitalist productivity payments and high-value care culture. J Hosp Med. 2019;14(1):16-21.

Dr. Huang is a physician adviser and associate clinical professor in the division of hospital medicine at the University of California, San Diego.

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Endoscopic therapy decreases recurrence of intestinal metaplasia, dysplasia in patients with Barrett’s esophagus

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A study of patients with Barrett’s esophagus found that, although intestinal metaplasia and dysplasia in the cardia were common before treatment, they were more frequently present at higher levels and successful endoscopic eradication therapy lessened the risk.

©Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

“The results of this study provide evidence to suggest that, in Barrett’s esophagus patients who have achieved CEIM [complete eradication of intestinal metaplasia], it is sufficient to perform a close examination of the cardia and, in the absence of visible abnormalities, to randomly biopsy only at the level of TGF [top of gastric folds], rather than deeper into the cardia, during surveillance exams,” wrote Swathi Eluri, MD, of the University of North Carolina in Chapel Hill and coauthors. The study was published in Clinical Gastroenterology and Hepatology.

To determine the prevalence of intestinal metaplasia or dysplasia in the cardia of patients with Barrett’s esophagus who successfully underwent endoscopic eradication therapy (EET), along with the incidence of cardia intestinal metaplasia or dysplasia in patients undergoing EET, this single-center study examined two groups: a cross-sectional group of 116 patients who had achieved CEIM, and a longitudinal group of 42 treatment-naive patients who were receiving EET and subsequently achieved CEIM.

Along with clinical biopsies, the cross-sectional group underwent standardized biopsies from four quadrants in four locations: the distal esophagus, 1 cm proximal to top of gastric folds (TGF–1); at TGF; 1 cm into the gastric cardia (TGF+1); and 2 cm into the cardia (TGF+2). The longitudinal group also underwent 16 biopsies in the same areas; after CEIM was achieved, they underwent standard research biopsies of the distal esophagus and cardia at 6- and 18-month follow-ups.

Within the cross-sectional group, 15% of patients (n = 17) had intestinal metaplasia or dysplasia in the cardia after CEIM. Of those 17 patients, 12 had intestinal metaplasia, 2 were indefinite for dysplasia, and 3 had low-grade dysplasia. Of the 12 patients with cardia intestinal metaplasia, 83% had it at the level of TGF; 50% at TGF+1; and 25% at TGF+2.

Within the longitudinal group, 28% of patients (n = 12) had intestinal metaplasia or dysplasia in the cardia before ablation. Of those 12 patients, 9 had dysplastic intestinal metaplasia. Cases of pretreatment dysplasia were all found at the level of TGF, with one case extended to TGF+1. All patients achieved CEIM; at 18 months post CEIM, two patients had intestinal metaplasia and none had dysplasia.

The authors shared their study’s limitations, which included the lack of generalizability of a single-center study and a notable number of dropouts in the longitudinal group. They also acknowledged using multiple ablation modalities, although they added that most patients in both groups underwent radiofrequency ablation, the most commonly used treatment method and one that made “the results of the study more applicable to real-world practice.”

In turn, the authors noted their study’s strengths, which included the collection of data in a standardized manner and the availability of complete ablation history for all patients. Theirs was also the first study to systematically sample the cardia at multiple levels, which allows for “a more granular understanding of the location of initial and incident cardia lesions, which can guide depth of ablation during EET.”

The study was funded by an American Gastroenterological Association Research Scholar Award and CSA Medical. The authors reported no conflicts of interest.

SOURCE: Eluri S et al. Clin Gastroenterol Hepatol. 2019 May 8. doi: 10.1016/j.cgh.2019.04.065.

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A study of patients with Barrett’s esophagus found that, although intestinal metaplasia and dysplasia in the cardia were common before treatment, they were more frequently present at higher levels and successful endoscopic eradication therapy lessened the risk.

©Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

“The results of this study provide evidence to suggest that, in Barrett’s esophagus patients who have achieved CEIM [complete eradication of intestinal metaplasia], it is sufficient to perform a close examination of the cardia and, in the absence of visible abnormalities, to randomly biopsy only at the level of TGF [top of gastric folds], rather than deeper into the cardia, during surveillance exams,” wrote Swathi Eluri, MD, of the University of North Carolina in Chapel Hill and coauthors. The study was published in Clinical Gastroenterology and Hepatology.

To determine the prevalence of intestinal metaplasia or dysplasia in the cardia of patients with Barrett’s esophagus who successfully underwent endoscopic eradication therapy (EET), along with the incidence of cardia intestinal metaplasia or dysplasia in patients undergoing EET, this single-center study examined two groups: a cross-sectional group of 116 patients who had achieved CEIM, and a longitudinal group of 42 treatment-naive patients who were receiving EET and subsequently achieved CEIM.

Along with clinical biopsies, the cross-sectional group underwent standardized biopsies from four quadrants in four locations: the distal esophagus, 1 cm proximal to top of gastric folds (TGF–1); at TGF; 1 cm into the gastric cardia (TGF+1); and 2 cm into the cardia (TGF+2). The longitudinal group also underwent 16 biopsies in the same areas; after CEIM was achieved, they underwent standard research biopsies of the distal esophagus and cardia at 6- and 18-month follow-ups.

Within the cross-sectional group, 15% of patients (n = 17) had intestinal metaplasia or dysplasia in the cardia after CEIM. Of those 17 patients, 12 had intestinal metaplasia, 2 were indefinite for dysplasia, and 3 had low-grade dysplasia. Of the 12 patients with cardia intestinal metaplasia, 83% had it at the level of TGF; 50% at TGF+1; and 25% at TGF+2.

Within the longitudinal group, 28% of patients (n = 12) had intestinal metaplasia or dysplasia in the cardia before ablation. Of those 12 patients, 9 had dysplastic intestinal metaplasia. Cases of pretreatment dysplasia were all found at the level of TGF, with one case extended to TGF+1. All patients achieved CEIM; at 18 months post CEIM, two patients had intestinal metaplasia and none had dysplasia.

The authors shared their study’s limitations, which included the lack of generalizability of a single-center study and a notable number of dropouts in the longitudinal group. They also acknowledged using multiple ablation modalities, although they added that most patients in both groups underwent radiofrequency ablation, the most commonly used treatment method and one that made “the results of the study more applicable to real-world practice.”

In turn, the authors noted their study’s strengths, which included the collection of data in a standardized manner and the availability of complete ablation history for all patients. Theirs was also the first study to systematically sample the cardia at multiple levels, which allows for “a more granular understanding of the location of initial and incident cardia lesions, which can guide depth of ablation during EET.”

The study was funded by an American Gastroenterological Association Research Scholar Award and CSA Medical. The authors reported no conflicts of interest.

SOURCE: Eluri S et al. Clin Gastroenterol Hepatol. 2019 May 8. doi: 10.1016/j.cgh.2019.04.065.

 

A study of patients with Barrett’s esophagus found that, although intestinal metaplasia and dysplasia in the cardia were common before treatment, they were more frequently present at higher levels and successful endoscopic eradication therapy lessened the risk.

©Nephron/Wikimedia Commons/CC BY-SA 3.0/No changes

“The results of this study provide evidence to suggest that, in Barrett’s esophagus patients who have achieved CEIM [complete eradication of intestinal metaplasia], it is sufficient to perform a close examination of the cardia and, in the absence of visible abnormalities, to randomly biopsy only at the level of TGF [top of gastric folds], rather than deeper into the cardia, during surveillance exams,” wrote Swathi Eluri, MD, of the University of North Carolina in Chapel Hill and coauthors. The study was published in Clinical Gastroenterology and Hepatology.

To determine the prevalence of intestinal metaplasia or dysplasia in the cardia of patients with Barrett’s esophagus who successfully underwent endoscopic eradication therapy (EET), along with the incidence of cardia intestinal metaplasia or dysplasia in patients undergoing EET, this single-center study examined two groups: a cross-sectional group of 116 patients who had achieved CEIM, and a longitudinal group of 42 treatment-naive patients who were receiving EET and subsequently achieved CEIM.

Along with clinical biopsies, the cross-sectional group underwent standardized biopsies from four quadrants in four locations: the distal esophagus, 1 cm proximal to top of gastric folds (TGF–1); at TGF; 1 cm into the gastric cardia (TGF+1); and 2 cm into the cardia (TGF+2). The longitudinal group also underwent 16 biopsies in the same areas; after CEIM was achieved, they underwent standard research biopsies of the distal esophagus and cardia at 6- and 18-month follow-ups.

Within the cross-sectional group, 15% of patients (n = 17) had intestinal metaplasia or dysplasia in the cardia after CEIM. Of those 17 patients, 12 had intestinal metaplasia, 2 were indefinite for dysplasia, and 3 had low-grade dysplasia. Of the 12 patients with cardia intestinal metaplasia, 83% had it at the level of TGF; 50% at TGF+1; and 25% at TGF+2.

Within the longitudinal group, 28% of patients (n = 12) had intestinal metaplasia or dysplasia in the cardia before ablation. Of those 12 patients, 9 had dysplastic intestinal metaplasia. Cases of pretreatment dysplasia were all found at the level of TGF, with one case extended to TGF+1. All patients achieved CEIM; at 18 months post CEIM, two patients had intestinal metaplasia and none had dysplasia.

The authors shared their study’s limitations, which included the lack of generalizability of a single-center study and a notable number of dropouts in the longitudinal group. They also acknowledged using multiple ablation modalities, although they added that most patients in both groups underwent radiofrequency ablation, the most commonly used treatment method and one that made “the results of the study more applicable to real-world practice.”

In turn, the authors noted their study’s strengths, which included the collection of data in a standardized manner and the availability of complete ablation history for all patients. Theirs was also the first study to systematically sample the cardia at multiple levels, which allows for “a more granular understanding of the location of initial and incident cardia lesions, which can guide depth of ablation during EET.”

The study was funded by an American Gastroenterological Association Research Scholar Award and CSA Medical. The authors reported no conflicts of interest.

SOURCE: Eluri S et al. Clin Gastroenterol Hepatol. 2019 May 8. doi: 10.1016/j.cgh.2019.04.065.

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