Three years after gabapentin received US Food and Drug Administration (FDA) approval in 1990 for epilepsy, case reports and animal studies emerged announcing its potential in the treatment of pain syndromes through then-novel analgesic mechanisms.¹ Fast forward 20 years to 2016: gabapentin and its close cousin, pregabalin, are internationally considered first-line agents for the treatment of neuropathic pain in guidelines from the Centers for Disease Control and Prevention, the Canadian Pain Society, and the National Institute for Health and Care Excellence. Gabapentin is the 10th most prescribed drug in the United States, and brand-name pregabalin sales were $4.4 billion USD, ranking 8th in invoice drug spending.²

The ascendancy of gabapentinoids as drugs of choice for pain, though, is fraught with controversy; yet, they were shepherded to commercial success. In 2004, the patent owner of gabapentin, Warner-Lambert (now owned by Pfizer), admitted guilt to charges that it violated federal regulations in its promotion: they encouraged off-label prescribing through paid physician-to-physician communications, publication of positive outcomes, and suppression of negative ones.³ Pfizer paid another settlement in 2009 for false claims about off-label indications for brand-name pregabalin.⁴

Mindful of historical biases, recent trials and meta-analyses have found less favorable outcomes for gabapentinoids in the treatment of off-label pain conditions and greater risks than previously reported. Cochrane reviews for gabapentin demonstrate efficacy only in postherpetic neuralgia (for which it has FDA approval) and diabetic peripheral neuropathy (for which it does not); pregabalin has efficacy in both these conditions as well as posttraumatic neuropathic pain and fibromyalgia (and FDA approval for all four). For other types of neuropathic pain, the evidence is of lower quality. Even for approved indications, the risk–benefit ratio is questionable, as the numbers needed to harm for dizziness and somnolence are similar to the numbers needed to treat for pain.^5,6 Further, case–control studies have found increased odds of opioid-related death when gabapentinoids were coprescribed with opioids,^7,8 prompting gabapentinoids to be reclassified as class C controlled substances in the UK as of April 2019.⁹

On this backdrop, Gingras and colleagues publish their retrospective cohort study on high-risk prescribing of these popular drugs in Montreal, Canada in this issue of Journal of Hospital Medicine.¹⁰ In their retrospective cohort study of 4,103 patients admitted to a clinical teaching unit, more than one in eight patients (13%) were being prescribed a gabapentinoid as an outpatient; chart review of the admission notes indicated that only 17% of them had an FDA-approved indication and 28% had no clear indication. Gabapentinoid users were more likely to be coprescribed an opioid than nonusers (28% vs 12%). There was no significant difference in length of stay or inpatient death between users and nonusers.

Gingras et al. thereby conclude that there is an opportunity to deprescribe on the basis of few gabapentinoid users having a documented indication and the recent research showing potentials for harm and abuse.¹¹ We agree. Messaging around gabapentinoids should be similar to that for opioids: these are medications with limited evidence supporting their use in the treatment of chronic pain, and prescribing them for unapproved indications risks doing greater harm than good. We offer two recommendations on how hospitalists can proceed with deprescribing them safely.

First, the urgency of deprescribing in inpatient settings should be titrated to the degree of risk. When the reason for hospitalization is potentially an adverse drug effect, culprit medications posing a substantial and near-term risk of harm should be stopped, such as when patients on gabapentinoids present with major alteration of their mental status.

In less urgent circumstances, hospitalists should speak first with outpatient prescribers because they may have important contextual information (eg, indication, patient preference, failure of alternative therapies, etc.) about previous care that the inpatient clinician lacks. For gabapentinoids, it is easy to imagine how treated pain syndromes without objective markers of disease may escape notice by a hospitalist and remain undocumented, which may encourage erroneous deprescribing. If the shared decision between the patient and providers is to deprescribe, patients on high doses warrant a tapering schedule.¹¹ Pharmacist consultation can help with this.

Second, before discharge, hospitalists should communicate their rationale for deprescribing medications to both patients and outpatient prescribers, especially if a prolonged tapering schedule is required. This type of communication occurred infrequently in this study: the reason for deprescribing a gabapentinoid was missing from the discharge summary 55% of the time. Without this, outpatient prescribers may simply reinitiate the medication after the patient is discharged.

To counter the overuse of gabapentinoids, hospitalists should look for opportunities to deprescribe them where there is concern about adverse events and when evidence-based indications do not exist. Successful deprescribing of these popular drugs will require deliberate collaboration and communication with the outpatient circle of care, as ongoing deprescribing ultimately depends on patients and outpatient prescribers agreeing to the change.

Disclosures

Dr. Steinman served as an unpaid expert witness in United States of America ex. Rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert Company and Pfizer, Inc, litigation which alleged that the named pharmaceutical companies improperly marketed gabapentin for non-FDA-approved uses. Drs. Lam and Rochon have no conflicts of interest to declare.

Funding

Dr. Rochon is supported by the Retired Teachers of Ontario (RTO/ERO) Chair in Geriatric Medicine at the University of Toronto. Dr. Steinman is supported by the National Institute on Aging, US (K24AG049057 and P30AG044281).

Three years after gabapentin received US Food and Drug Administration (FDA) approval in 1990 for epilepsy, case reports and animal studies emerged announcing its potential in the treatment of pain syndromes through then-novel analgesic mechanisms.¹ Fast forward 20 years to 2016: gabapentin and its close cousin, pregabalin, are internationally considered first-line agents for the treatment of neuropathic pain in guidelines from the Centers for Disease Control and Prevention, the Canadian Pain Society, and the National Institute for Health and Care Excellence. Gabapentin is the 10th most prescribed drug in the United States, and brand-name pregabalin sales were $4.4 billion USD, ranking 8th in invoice drug spending.²

The ascendancy of gabapentinoids as drugs of choice for pain, though, is fraught with controversy; yet, they were shepherded to commercial success. In 2004, the patent owner of gabapentin, Warner-Lambert (now owned by Pfizer), admitted guilt to charges that it violated federal regulations in its promotion: they encouraged off-label prescribing through paid physician-to-physician communications, publication of positive outcomes, and suppression of negative ones.³ Pfizer paid another settlement in 2009 for false claims about off-label indications for brand-name pregabalin.⁴

Mindful of historical biases, recent trials and meta-analyses have found less favorable outcomes for gabapentinoids in the treatment of off-label pain conditions and greater risks than previously reported. Cochrane reviews for gabapentin demonstrate efficacy only in postherpetic neuralgia (for which it has FDA approval) and diabetic peripheral neuropathy (for which it does not); pregabalin has efficacy in both these conditions as well as posttraumatic neuropathic pain and fibromyalgia (and FDA approval for all four). For other types of neuropathic pain, the evidence is of lower quality. Even for approved indications, the risk–benefit ratio is questionable, as the numbers needed to harm for dizziness and somnolence are similar to the numbers needed to treat for pain.^5,6 Further, case–control studies have found increased odds of opioid-related death when gabapentinoids were coprescribed with opioids,^7,8 prompting gabapentinoids to be reclassified as class C controlled substances in the UK as of April 2019.⁹

On this backdrop, Gingras and colleagues publish their retrospective cohort study on high-risk prescribing of these popular drugs in Montreal, Canada in this issue of Journal of Hospital Medicine.¹⁰ In their retrospective cohort study of 4,103 patients admitted to a clinical teaching unit, more than one in eight patients (13%) were being prescribed a gabapentinoid as an outpatient; chart review of the admission notes indicated that only 17% of them had an FDA-approved indication and 28% had no clear indication. Gabapentinoid users were more likely to be coprescribed an opioid than nonusers (28% vs 12%). There was no significant difference in length of stay or inpatient death between users and nonusers.

Gingras et al. thereby conclude that there is an opportunity to deprescribe on the basis of few gabapentinoid users having a documented indication and the recent research showing potentials for harm and abuse.¹¹ We agree. Messaging around gabapentinoids should be similar to that for opioids: these are medications with limited evidence supporting their use in the treatment of chronic pain, and prescribing them for unapproved indications risks doing greater harm than good. We offer two recommendations on how hospitalists can proceed with deprescribing them safely.

First, the urgency of deprescribing in inpatient settings should be titrated to the degree of risk. When the reason for hospitalization is potentially an adverse drug effect, culprit medications posing a substantial and near-term risk of harm should be stopped, such as when patients on gabapentinoids present with major alteration of their mental status.

In less urgent circumstances, hospitalists should speak first with outpatient prescribers because they may have important contextual information (eg, indication, patient preference, failure of alternative therapies, etc.) about previous care that the inpatient clinician lacks. For gabapentinoids, it is easy to imagine how treated pain syndromes without objective markers of disease may escape notice by a hospitalist and remain undocumented, which may encourage erroneous deprescribing. If the shared decision between the patient and providers is to deprescribe, patients on high doses warrant a tapering schedule.¹¹ Pharmacist consultation can help with this.

Second, before discharge, hospitalists should communicate their rationale for deprescribing medications to both patients and outpatient prescribers, especially if a prolonged tapering schedule is required. This type of communication occurred infrequently in this study: the reason for deprescribing a gabapentinoid was missing from the discharge summary 55% of the time. Without this, outpatient prescribers may simply reinitiate the medication after the patient is discharged.

To counter the overuse of gabapentinoids, hospitalists should look for opportunities to deprescribe them where there is concern about adverse events and when evidence-based indications do not exist. Successful deprescribing of these popular drugs will require deliberate collaboration and communication with the outpatient circle of care, as ongoing deprescribing ultimately depends on patients and outpatient prescribers agreeing to the change.

Disclosures

Dr. Steinman served as an unpaid expert witness in United States of America ex. Rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert Company and Pfizer, Inc, litigation which alleged that the named pharmaceutical companies improperly marketed gabapentin for non-FDA-approved uses. Drs. Lam and Rochon have no conflicts of interest to declare.

Funding

Dr. Rochon is supported by the Retired Teachers of Ontario (RTO/ERO) Chair in Geriatric Medicine at the University of Toronto. Dr. Steinman is supported by the National Institute on Aging, US (K24AG049057 and P30AG044281).

Three years after gabapentin received US Food and Drug Administration (FDA) approval in 1990 for epilepsy, case reports and animal studies emerged announcing its potential in the treatment of pain syndromes through then-novel analgesic mechanisms.¹ Fast forward 20 years to 2016: gabapentin and its close cousin, pregabalin, are internationally considered first-line agents for the treatment of neuropathic pain in guidelines from the Centers for Disease Control and Prevention, the Canadian Pain Society, and the National Institute for Health and Care Excellence. Gabapentin is the 10th most prescribed drug in the United States, and brand-name pregabalin sales were $4.4 billion USD, ranking 8th in invoice drug spending.²

The ascendancy of gabapentinoids as drugs of choice for pain, though, is fraught with controversy; yet, they were shepherded to commercial success. In 2004, the patent owner of gabapentin, Warner-Lambert (now owned by Pfizer), admitted guilt to charges that it violated federal regulations in its promotion: they encouraged off-label prescribing through paid physician-to-physician communications, publication of positive outcomes, and suppression of negative ones.³ Pfizer paid another settlement in 2009 for false claims about off-label indications for brand-name pregabalin.⁴

Mindful of historical biases, recent trials and meta-analyses have found less favorable outcomes for gabapentinoids in the treatment of off-label pain conditions and greater risks than previously reported. Cochrane reviews for gabapentin demonstrate efficacy only in postherpetic neuralgia (for which it has FDA approval) and diabetic peripheral neuropathy (for which it does not); pregabalin has efficacy in both these conditions as well as posttraumatic neuropathic pain and fibromyalgia (and FDA approval for all four). For other types of neuropathic pain, the evidence is of lower quality. Even for approved indications, the risk–benefit ratio is questionable, as the numbers needed to harm for dizziness and somnolence are similar to the numbers needed to treat for pain.^5,6 Further, case–control studies have found increased odds of opioid-related death when gabapentinoids were coprescribed with opioids,^7,8 prompting gabapentinoids to be reclassified as class C controlled substances in the UK as of April 2019.⁹

On this backdrop, Gingras and colleagues publish their retrospective cohort study on high-risk prescribing of these popular drugs in Montreal, Canada in this issue of Journal of Hospital Medicine.¹⁰ In their retrospective cohort study of 4,103 patients admitted to a clinical teaching unit, more than one in eight patients (13%) were being prescribed a gabapentinoid as an outpatient; chart review of the admission notes indicated that only 17% of them had an FDA-approved indication and 28% had no clear indication. Gabapentinoid users were more likely to be coprescribed an opioid than nonusers (28% vs 12%). There was no significant difference in length of stay or inpatient death between users and nonusers.

Gingras et al. thereby conclude that there is an opportunity to deprescribe on the basis of few gabapentinoid users having a documented indication and the recent research showing potentials for harm and abuse.¹¹ We agree. Messaging around gabapentinoids should be similar to that for opioids: these are medications with limited evidence supporting their use in the treatment of chronic pain, and prescribing them for unapproved indications risks doing greater harm than good. We offer two recommendations on how hospitalists can proceed with deprescribing them safely.

First, the urgency of deprescribing in inpatient settings should be titrated to the degree of risk. When the reason for hospitalization is potentially an adverse drug effect, culprit medications posing a substantial and near-term risk of harm should be stopped, such as when patients on gabapentinoids present with major alteration of their mental status.

In less urgent circumstances, hospitalists should speak first with outpatient prescribers because they may have important contextual information (eg, indication, patient preference, failure of alternative therapies, etc.) about previous care that the inpatient clinician lacks. For gabapentinoids, it is easy to imagine how treated pain syndromes without objective markers of disease may escape notice by a hospitalist and remain undocumented, which may encourage erroneous deprescribing. If the shared decision between the patient and providers is to deprescribe, patients on high doses warrant a tapering schedule.¹¹ Pharmacist consultation can help with this.

Second, before discharge, hospitalists should communicate their rationale for deprescribing medications to both patients and outpatient prescribers, especially if a prolonged tapering schedule is required. This type of communication occurred infrequently in this study: the reason for deprescribing a gabapentinoid was missing from the discharge summary 55% of the time. Without this, outpatient prescribers may simply reinitiate the medication after the patient is discharged.

To counter the overuse of gabapentinoids, hospitalists should look for opportunities to deprescribe them where there is concern about adverse events and when evidence-based indications do not exist. Successful deprescribing of these popular drugs will require deliberate collaboration and communication with the outpatient circle of care, as ongoing deprescribing ultimately depends on patients and outpatient prescribers agreeing to the change.

Disclosures

Dr. Steinman served as an unpaid expert witness in United States of America ex. Rel. David Franklin vs. Parke-Davis, Division of Warner-Lambert Company and Pfizer, Inc, litigation which alleged that the named pharmaceutical companies improperly marketed gabapentin for non-FDA-approved uses. Drs. Lam and Rochon have no conflicts of interest to declare.

Funding

Dr. Rochon is supported by the Retired Teachers of Ontario (RTO/ERO) Chair in Geriatric Medicine at the University of Toronto. Dr. Steinman is supported by the National Institute on Aging, US (K24AG049057 and P30AG044281).

Rapid dissemination and adoption of evidence-based guidelines remains a challenge despite studies showing that key evidence-based care processes improve outcomes in sepsis and heart failure.¹ Hospital medicine was virtually founded on the premise that hospitalists would be champions of delivering high-quality care. Hospitalists are now dealing with a new challenge—unprecedented growth of healthcare systems because of mergers and acquisitions. The year 2018 was a banner time for healthcare mergers and acquisitions, with a total of 1,182, up 14% from 2017.² These are in response to the belief that healthcare systems may better navigate the mixed reimbursement models of fee-for-service and fee-for-value by achieving a larger patient base and economies of scale. Hospitalists must now achieve consistent, evidence-based standards of care across larger networks by educating their colleagues (often separated by large geographic areas) to manifest durable changes in their group practice with demonstrable improvement in patient outcomes and cost savings.

The study by Yurso et al. focused on implementing an education program, which included standardized learning through Clinical Performance and Value (CPV) vignettes with process measurement and feedback for sepsis and heart failure.³ Sepsis and heart failure have been a focus for treatment standardization because of the associated morbidity, mortality, and high cost of care. The study by Yurso et al. is a prospective quasi-controlled cohort of hospitalists in eight hospitals who were matched with comparator hospitalists in six nonparticipating hospitals across the AdventHealth system. Measurement and feedback were provided using CPV vignettes. Over two years, hospitalists who participated improved CPV scores by 8%, compliance with the utilization of the three-hour sepsis bundle from 46.0% to 57.5%, and orders of essential medical treatment elements for heart failure from 58.2% to 72.1%. In year one, the average length of stay (LOS) observed/expected (O/E) rates dropped by 8% for participating hospitalists compared with 2.5% in the comparator group. By year two, cost O/E rates improved slightly resulting in cost savings. The authors concluded that CPV case simulation-based measurement and feedback helped drive improvements in evidence-based care, which was associated with lower costs and shorter LOS.

While studies using traditional didactic CME struggle to demonstrate changes in practice leading to improved patient outcomes,⁴ the study by Yurso et al. gives a glimpse into how simulation can be used to help improve clinical performance and measure adherence to best practice. A remarkably similar study used CPV for simulated patients with serial performance measurement and feedback for heart failure and pneumonia. The study showed reduced practice variation between hospitalists at 11 hospitals across four states and decreased LOS and readmissions. However, the sole clinical outcome was no change in in-house mortality.⁵ Another study using CPV training in breast cancer treatment demonstrated increased adherence to evidence-based practice standards and decreased variation in care between providers across four states.⁶ Of note, this study did not include clinical outcomes. These studies collectively imply that simulation training with interactive learning, educational feedback, repetitive practice, and curriculum integration has shown modest success in creating practice change and improving adherence to best practice standards. However, they have minimal measures of patient outcomes and fairly simple analyses for cost savings. Because the education is computer-based and feedback can be performed remotely, it can be deployed across large and diverse growing healthcare systems. To really move the needle, future research in the field of simulation should identify optimal simulation methods and be designed with more rigor to include patient and cost outcomes.

At Intermountain Healthcare, hospitalist expansion occurred through a strategic realignment from the different geographic regions into the One Intermountain model. This model is built on the commitment that our patients will receive the same high-quality, high-value care wherever they walk through our doors. We have found four substantive changes have been particularly powerful in spurring a group practice mentality toward standardizing best practice. One, hospitalists are now aligned across the system under a single operational leadership structure that encourages combined efforts to share best practices and develop and deploy strategic initiatives around them. Two, hospitalists continue to build on a culture of quality and measure what matters to patients. While Intermountain Healthcare has a long history of using quality improvement to achieve better patient outcomes and lower costs,⁷ the new structure is allowing our group to test novel methods including redesigned education to see what actually improves adherence to best practice. Three, the group knows where the system’s reimbursement is coming from; Intermountain Healthcare has transitioned to a larger percentage of capitation,⁸ currently about 40%, with a strong commitment to partner with services geared to transition patients home quickly and keep them at home. Four, the organization has created a structure of accountability and reporting; an executive-sponsored systemwide operating model has been designed to cut through system barriers being identified by the frontline, allowing them to be rapidly surfaced and then solved at the executive level through daily huddles.⁹

Innovative educational programs such as the one described in the study by Yurso et al. that help the busy hospitalist achieve improved adherence to best practice are likely to be an important component leading to improved outcomes, but only after a group has been structured for success. As hospitalist groups continue to act as a single effector arm for high-value care, this will help meet the expectations of our patients and deliver on the promise of our field.

Disclosures: Dr. Srivastava is a physician founder of the I- PASS Patient Safety Institute. His employer, Intermountain Healthcare owns his equity in the I-PASS Patient Safety Institute. Dr. Srivastava is supported in part by the Children’s Hospital Association for his work as an executive council member of the Pediatric Research in Inpatient Settings (PRIS) network. Dr. Srivastava has received monetary awards, honorariums, and travel reimbursement from multiple academic and professional organizations for talks about pediatric hospitalist research networks and quality of care. All other authors have nothing to disclose. No funding was provided for this editorial.

Disclosures

The authors have no disclosures of financial conflicts of interest.

Funding

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

Rapid dissemination and adoption of evidence-based guidelines remains a challenge despite studies showing that key evidence-based care processes improve outcomes in sepsis and heart failure.¹ Hospital medicine was virtually founded on the premise that hospitalists would be champions of delivering high-quality care. Hospitalists are now dealing with a new challenge—unprecedented growth of healthcare systems because of mergers and acquisitions. The year 2018 was a banner time for healthcare mergers and acquisitions, with a total of 1,182, up 14% from 2017.² These are in response to the belief that healthcare systems may better navigate the mixed reimbursement models of fee-for-service and fee-for-value by achieving a larger patient base and economies of scale. Hospitalists must now achieve consistent, evidence-based standards of care across larger networks by educating their colleagues (often separated by large geographic areas) to manifest durable changes in their group practice with demonstrable improvement in patient outcomes and cost savings.

The study by Yurso et al. focused on implementing an education program, which included standardized learning through Clinical Performance and Value (CPV) vignettes with process measurement and feedback for sepsis and heart failure.³ Sepsis and heart failure have been a focus for treatment standardization because of the associated morbidity, mortality, and high cost of care. The study by Yurso et al. is a prospective quasi-controlled cohort of hospitalists in eight hospitals who were matched with comparator hospitalists in six nonparticipating hospitals across the AdventHealth system. Measurement and feedback were provided using CPV vignettes. Over two years, hospitalists who participated improved CPV scores by 8%, compliance with the utilization of the three-hour sepsis bundle from 46.0% to 57.5%, and orders of essential medical treatment elements for heart failure from 58.2% to 72.1%. In year one, the average length of stay (LOS) observed/expected (O/E) rates dropped by 8% for participating hospitalists compared with 2.5% in the comparator group. By year two, cost O/E rates improved slightly resulting in cost savings. The authors concluded that CPV case simulation-based measurement and feedback helped drive improvements in evidence-based care, which was associated with lower costs and shorter LOS.

While studies using traditional didactic CME struggle to demonstrate changes in practice leading to improved patient outcomes,⁴ the study by Yurso et al. gives a glimpse into how simulation can be used to help improve clinical performance and measure adherence to best practice. A remarkably similar study used CPV for simulated patients with serial performance measurement and feedback for heart failure and pneumonia. The study showed reduced practice variation between hospitalists at 11 hospitals across four states and decreased LOS and readmissions. However, the sole clinical outcome was no change in in-house mortality.⁵ Another study using CPV training in breast cancer treatment demonstrated increased adherence to evidence-based practice standards and decreased variation in care between providers across four states.⁶ Of note, this study did not include clinical outcomes. These studies collectively imply that simulation training with interactive learning, educational feedback, repetitive practice, and curriculum integration has shown modest success in creating practice change and improving adherence to best practice standards. However, they have minimal measures of patient outcomes and fairly simple analyses for cost savings. Because the education is computer-based and feedback can be performed remotely, it can be deployed across large and diverse growing healthcare systems. To really move the needle, future research in the field of simulation should identify optimal simulation methods and be designed with more rigor to include patient and cost outcomes.

At Intermountain Healthcare, hospitalist expansion occurred through a strategic realignment from the different geographic regions into the One Intermountain model. This model is built on the commitment that our patients will receive the same high-quality, high-value care wherever they walk through our doors. We have found four substantive changes have been particularly powerful in spurring a group practice mentality toward standardizing best practice. One, hospitalists are now aligned across the system under a single operational leadership structure that encourages combined efforts to share best practices and develop and deploy strategic initiatives around them. Two, hospitalists continue to build on a culture of quality and measure what matters to patients. While Intermountain Healthcare has a long history of using quality improvement to achieve better patient outcomes and lower costs,⁷ the new structure is allowing our group to test novel methods including redesigned education to see what actually improves adherence to best practice. Three, the group knows where the system’s reimbursement is coming from; Intermountain Healthcare has transitioned to a larger percentage of capitation,⁸ currently about 40%, with a strong commitment to partner with services geared to transition patients home quickly and keep them at home. Four, the organization has created a structure of accountability and reporting; an executive-sponsored systemwide operating model has been designed to cut through system barriers being identified by the frontline, allowing them to be rapidly surfaced and then solved at the executive level through daily huddles.⁹

Innovative educational programs such as the one described in the study by Yurso et al. that help the busy hospitalist achieve improved adherence to best practice are likely to be an important component leading to improved outcomes, but only after a group has been structured for success. As hospitalist groups continue to act as a single effector arm for high-value care, this will help meet the expectations of our patients and deliver on the promise of our field.

Disclosures: Dr. Srivastava is a physician founder of the I- PASS Patient Safety Institute. His employer, Intermountain Healthcare owns his equity in the I-PASS Patient Safety Institute. Dr. Srivastava is supported in part by the Children’s Hospital Association for his work as an executive council member of the Pediatric Research in Inpatient Settings (PRIS) network. Dr. Srivastava has received monetary awards, honorariums, and travel reimbursement from multiple academic and professional organizations for talks about pediatric hospitalist research networks and quality of care. All other authors have nothing to disclose. No funding was provided for this editorial.

Disclosures

The authors have no disclosures of financial conflicts of interest.

Funding

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

Rapid dissemination and adoption of evidence-based guidelines remains a challenge despite studies showing that key evidence-based care processes improve outcomes in sepsis and heart failure.¹ Hospital medicine was virtually founded on the premise that hospitalists would be champions of delivering high-quality care. Hospitalists are now dealing with a new challenge—unprecedented growth of healthcare systems because of mergers and acquisitions. The year 2018 was a banner time for healthcare mergers and acquisitions, with a total of 1,182, up 14% from 2017.² These are in response to the belief that healthcare systems may better navigate the mixed reimbursement models of fee-for-service and fee-for-value by achieving a larger patient base and economies of scale. Hospitalists must now achieve consistent, evidence-based standards of care across larger networks by educating their colleagues (often separated by large geographic areas) to manifest durable changes in their group practice with demonstrable improvement in patient outcomes and cost savings.

The study by Yurso et al. focused on implementing an education program, which included standardized learning through Clinical Performance and Value (CPV) vignettes with process measurement and feedback for sepsis and heart failure.³ Sepsis and heart failure have been a focus for treatment standardization because of the associated morbidity, mortality, and high cost of care. The study by Yurso et al. is a prospective quasi-controlled cohort of hospitalists in eight hospitals who were matched with comparator hospitalists in six nonparticipating hospitals across the AdventHealth system. Measurement and feedback were provided using CPV vignettes. Over two years, hospitalists who participated improved CPV scores by 8%, compliance with the utilization of the three-hour sepsis bundle from 46.0% to 57.5%, and orders of essential medical treatment elements for heart failure from 58.2% to 72.1%. In year one, the average length of stay (LOS) observed/expected (O/E) rates dropped by 8% for participating hospitalists compared with 2.5% in the comparator group. By year two, cost O/E rates improved slightly resulting in cost savings. The authors concluded that CPV case simulation-based measurement and feedback helped drive improvements in evidence-based care, which was associated with lower costs and shorter LOS.

While studies using traditional didactic CME struggle to demonstrate changes in practice leading to improved patient outcomes,⁴ the study by Yurso et al. gives a glimpse into how simulation can be used to help improve clinical performance and measure adherence to best practice. A remarkably similar study used CPV for simulated patients with serial performance measurement and feedback for heart failure and pneumonia. The study showed reduced practice variation between hospitalists at 11 hospitals across four states and decreased LOS and readmissions. However, the sole clinical outcome was no change in in-house mortality.⁵ Another study using CPV training in breast cancer treatment demonstrated increased adherence to evidence-based practice standards and decreased variation in care between providers across four states.⁶ Of note, this study did not include clinical outcomes. These studies collectively imply that simulation training with interactive learning, educational feedback, repetitive practice, and curriculum integration has shown modest success in creating practice change and improving adherence to best practice standards. However, they have minimal measures of patient outcomes and fairly simple analyses for cost savings. Because the education is computer-based and feedback can be performed remotely, it can be deployed across large and diverse growing healthcare systems. To really move the needle, future research in the field of simulation should identify optimal simulation methods and be designed with more rigor to include patient and cost outcomes.

At Intermountain Healthcare, hospitalist expansion occurred through a strategic realignment from the different geographic regions into the One Intermountain model. This model is built on the commitment that our patients will receive the same high-quality, high-value care wherever they walk through our doors. We have found four substantive changes have been particularly powerful in spurring a group practice mentality toward standardizing best practice. One, hospitalists are now aligned across the system under a single operational leadership structure that encourages combined efforts to share best practices and develop and deploy strategic initiatives around them. Two, hospitalists continue to build on a culture of quality and measure what matters to patients. While Intermountain Healthcare has a long history of using quality improvement to achieve better patient outcomes and lower costs,⁷ the new structure is allowing our group to test novel methods including redesigned education to see what actually improves adherence to best practice. Three, the group knows where the system’s reimbursement is coming from; Intermountain Healthcare has transitioned to a larger percentage of capitation,⁸ currently about 40%, with a strong commitment to partner with services geared to transition patients home quickly and keep them at home. Four, the organization has created a structure of accountability and reporting; an executive-sponsored systemwide operating model has been designed to cut through system barriers being identified by the frontline, allowing them to be rapidly surfaced and then solved at the executive level through daily huddles.⁹

Innovative educational programs such as the one described in the study by Yurso et al. that help the busy hospitalist achieve improved adherence to best practice are likely to be an important component leading to improved outcomes, but only after a group has been structured for success. As hospitalist groups continue to act as a single effector arm for high-value care, this will help meet the expectations of our patients and deliver on the promise of our field.

Disclosures: Dr. Srivastava is a physician founder of the I- PASS Patient Safety Institute. His employer, Intermountain Healthcare owns his equity in the I-PASS Patient Safety Institute. Dr. Srivastava is supported in part by the Children’s Hospital Association for his work as an executive council member of the Pediatric Research in Inpatient Settings (PRIS) network. Dr. Srivastava has received monetary awards, honorariums, and travel reimbursement from multiple academic and professional organizations for talks about pediatric hospitalist research networks and quality of care. All other authors have nothing to disclose. No funding was provided for this editorial.

Disclosures

The authors have no disclosures of financial conflicts of interest.

Funding

Dr. Walke was supported 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).

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).

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 expenditures^1-3; 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 use^2,3,8,9—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 expenditures^1-3; 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 use^2,3,8,9—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 expenditures^1-3; 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 use^2,3,8,9—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.

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).

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).

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.

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.

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.

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 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 rosaceas@aol.com. 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 rosaceas@aol.com. 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 rosaceas@aol.com. The new booklet was made possible by support from Aclaris.

AUSTIN, TEX. – 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

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.

dbrunk@mdedge.com

AUSTIN, TEX. – 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

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.

dbrunk@mdedge.com

AUSTIN, TEX. – 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

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.

dbrunk@mdedge.com

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.

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.

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.

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.