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The Cruelty of April: Suicide in Spring

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The Cruelty of April: Suicide in Spring

April is the cruellest month, breeding
Lilacs out of the dead land, mixing
Memory and desire, stirring
Dull roots with spring rain.
T.S. Eliot1

The epigraph for this column is from The Waste Land, T.S. Eliot’s postmodern poem that, in part, reflects his experience of the destruction of an entire way of living and a generation of young men in the wake of the First World War. The terrible contemporary toll suicide has taken on veterans and the active-duty military makes it easy to forget that suicide is an inveterate and disturbing aftermath of all wars.2

There is a profound and elemental connection in the human mind between Spring and renewal. In almost every culture and religion, across nearly every historical epoch and location, Spring is associated with themes of growth, returning life, light, and hope. On a more prosaic modern level, almost all of us—us—especially those in Northern climates—look forward to warmer weather, more time spent outdoors, and the simple joys of seeing perennials return in the garden and birds nest in blooming trees.

It is a paradox of human life that suicide is more common in the season of rebirth than in the season of decline. The bare trees, freezing temperatures, and icy darkness that accompany winter in much of the world inherently lead us to contemplate our mortality. The counterintuitive finding that individuals, many of them veterans, take their own lives more often in Spring creates a cognitive dissonance to be explored in this editorial.

As a layperson, I too assumed there were more suicides in winter, especially around the holidays when the expectation of belonging, privilege, and pleasure painfully reminds the alienated, lonely, homeless, and ailing of all they lack and all they have lost. As a psychiatric intern, I anticipated that the inpatient US Department of Veterans Affairs (VA) ward where I was training would empty with the arrival of nicer weather. Instead, I was mystified when the opposite occurred and the unit was overflowing with manic and suicidal patients.

The Centers for Disease Control and Prevention National Center for Health Statistics ranked suicide by month from 1999 to 2010. Contrary to popular belief, more suicides occurred in late Spring and Summer than any other season.3 A 2023 study of systematic reviews of seasonal variation in mood disorders, suicide risk, and health care utilization found that suicide was 11% to 23% higher, suicide attempts resulting in emergency department visits showed an increase of 1.2% to 1.7%, and hospital admissions for mania rose 7.4% to 16.0% in Spring and Summer, compared with Fall and Winter.4 This general population finding is also seen in veteran and military cohorts. A recent study analyzed VA and US Department of Defense (DoD) data from 133,867 veteran suicides from 2001 to 2021. Results showed that veteran suicides were highest in Summer.5

The rise of suicide in the Spring was first observed in the 17th century and has been the object of scientific study for at least 3 decades. That research has produced several different hypotheses from a variety of disciplines, none of which are conclusive as of this writing. Cho and Lee note that the phrase “Spring fever” is a much more serious illness for those with a predisposition or diagnosis of unipolar or bipolar disorder than the quotidian irritant that afflicts those without affective disorders.6 In residency, I learned that longer exposure to light in Spring led to an imbalance in neurotransmitters that triggered manias. This is a simplistic version of the complex circadian interactions of temperature, climate, light, and other environmental variables causing dysregulation or misalignment of our natural biological cycles and those of nature proposed by chronobiologists.7

Sociological and criminal justice scholars underscore that an increase in temperature may exacerbate violent tendencies, especially in older males—a demographic profile more frequently found in veterans—and those already prone to acting out their frustrations with firearms.8 Psychologists have hypothesized that individuals with depressions persevere through Winter by telling themselves they will feel relief in the Spring. Too often the coming of Spring brings not reprieve but a deadly combination of deeper mental desperation coupled with the release from winter lassitude that energizes the now hopeless person to put ideation into action.4,9 The elevation of suicide rates in Spring is likely multidetermined with all these putative causes contributing in different variations to every individual who tragically dies by suicide.

Yet despite decades of public education, this dangerous fiction stubbornly persists in the educated public and even among many health care professionals, in part due to misguided media. For years, the Annenberg Public Policy Center (APPC) has made busting this myth of holiday suicides in the media an organizational initiative. A 2023 APPC survey found that 4 of 5 Americans picked December as the month when suicide rates were highest. The organization has been analyzing holiday—related media reports for decades; those results show some improvement, with the most recent analysis of media reports somewhat better and 40% communicating erroneous information. 10

APPC believes the opinion that suicide is more common around the holidays will persuade those struggling with an exacerbation of a mental health condition or an acute crisis to attempt or die by suicide, believing it to be a reasonable social response. While recognizing there is a real risk of such contagion behavior, I believe the reverse problem is more concerning. As I observed during my internship, the acceptance of the fiction that everyone is happy in Spring may even blind health care professionals from detecting clues that patients and even our loved ones are contemplating suicide. Our relief that Winter has passed and enjoyment of Spring activities can fool us into believing everyone else is also feeling fine and doing well and miss an opportunity to intervene and treat mania or depression to save a life—the medical manifestation of renewal.

References
  1. Elliot TS, North M. The Waste Land and Other Poems: A Norton Critical Edition. W.W. Norton & Company; 2022.
  2. Lester D. Suicide rates before, during, and after the world wars. Eur Psychiatry. 1994;9(5):262-264. doi:10.1017/S092493380000362X
  3. Centers for Disease Control Center and Prevention. National Center for Health Statistics. Fact or fiction: suicides increase during the holiday season and winter months. January 10, 2014. Accessed March 27, 2025. https://blogs.cdc.gov/nchs/2014/01/10/1121/
  4. Della DF, Allison S, Bidargaddi N, Wa SK, Bastiampillai T. An umbrella systematic review of seasonality in mood disorders and suicide risk: the impact on demand for primary behavioral health care and acute psychiatric services. Prim Care Companion CNS Disord. 2023;25(3):22r03395. doi:10.4088/PCC.22r03395
  5. Gold SA, Goodrich M, Morley SW, Stephens B, McCarthy JF. Temporal patterns of veteran suicide: variation by season, day of the week, and holidays. Suicide Life Threat Behav. 2025;55(2):e13148. doi:10.1111/sltb.13148
  6. Cho CH, Lee HJ. Why do mania and suicide occur most often in the Spring? Psychiatry Investig. 2018;15(3):232-234. doi:10.30773/pi.2017.12.20
  7. Postolache TT, Mortensen PB, Tonelli LH, et al. Seasonal spring peaks of suicide in victims with and without prior history of hospitalization for mood disorders. J Affect Disord. 2010;121(1-2):88-93. doi:10.1016/j.jad.2009.05.015
  8. Christodoulou C, Efstathiou V, Bouras G, Korkoliakou P, Lykouras L. Seasonal variation of suicide: a brief review. Encephalos. 2012;49:73-79.
  9. Shapiro M. Suicide rates spike in spring, not winter. Dome. May/June 2019. Accessed March 28, 2025. https://www.hopkinsmedicine.org/news/articles/2019/05/suicide-rates-spike-in-spring-not-winter
  10. Annenberg Public Policy Center. Suicides don’t spike around the holiday season, but Americans think they do. December 6, 2023. Accessed March 27, 2025. https:// www.asc.upenn.edu/news-events/news/suicides-dont-spike-around-holiday-season-americans-think-they-do
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Fed Pract. 2025;42(4). Published online April 14. doi:10.12788/fp.0580

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April is the cruellest month, breeding
Lilacs out of the dead land, mixing
Memory and desire, stirring
Dull roots with spring rain.
T.S. Eliot1

The epigraph for this column is from The Waste Land, T.S. Eliot’s postmodern poem that, in part, reflects his experience of the destruction of an entire way of living and a generation of young men in the wake of the First World War. The terrible contemporary toll suicide has taken on veterans and the active-duty military makes it easy to forget that suicide is an inveterate and disturbing aftermath of all wars.2

There is a profound and elemental connection in the human mind between Spring and renewal. In almost every culture and religion, across nearly every historical epoch and location, Spring is associated with themes of growth, returning life, light, and hope. On a more prosaic modern level, almost all of us—us—especially those in Northern climates—look forward to warmer weather, more time spent outdoors, and the simple joys of seeing perennials return in the garden and birds nest in blooming trees.

It is a paradox of human life that suicide is more common in the season of rebirth than in the season of decline. The bare trees, freezing temperatures, and icy darkness that accompany winter in much of the world inherently lead us to contemplate our mortality. The counterintuitive finding that individuals, many of them veterans, take their own lives more often in Spring creates a cognitive dissonance to be explored in this editorial.

As a layperson, I too assumed there were more suicides in winter, especially around the holidays when the expectation of belonging, privilege, and pleasure painfully reminds the alienated, lonely, homeless, and ailing of all they lack and all they have lost. As a psychiatric intern, I anticipated that the inpatient US Department of Veterans Affairs (VA) ward where I was training would empty with the arrival of nicer weather. Instead, I was mystified when the opposite occurred and the unit was overflowing with manic and suicidal patients.

The Centers for Disease Control and Prevention National Center for Health Statistics ranked suicide by month from 1999 to 2010. Contrary to popular belief, more suicides occurred in late Spring and Summer than any other season.3 A 2023 study of systematic reviews of seasonal variation in mood disorders, suicide risk, and health care utilization found that suicide was 11% to 23% higher, suicide attempts resulting in emergency department visits showed an increase of 1.2% to 1.7%, and hospital admissions for mania rose 7.4% to 16.0% in Spring and Summer, compared with Fall and Winter.4 This general population finding is also seen in veteran and military cohorts. A recent study analyzed VA and US Department of Defense (DoD) data from 133,867 veteran suicides from 2001 to 2021. Results showed that veteran suicides were highest in Summer.5

The rise of suicide in the Spring was first observed in the 17th century and has been the object of scientific study for at least 3 decades. That research has produced several different hypotheses from a variety of disciplines, none of which are conclusive as of this writing. Cho and Lee note that the phrase “Spring fever” is a much more serious illness for those with a predisposition or diagnosis of unipolar or bipolar disorder than the quotidian irritant that afflicts those without affective disorders.6 In residency, I learned that longer exposure to light in Spring led to an imbalance in neurotransmitters that triggered manias. This is a simplistic version of the complex circadian interactions of temperature, climate, light, and other environmental variables causing dysregulation or misalignment of our natural biological cycles and those of nature proposed by chronobiologists.7

Sociological and criminal justice scholars underscore that an increase in temperature may exacerbate violent tendencies, especially in older males—a demographic profile more frequently found in veterans—and those already prone to acting out their frustrations with firearms.8 Psychologists have hypothesized that individuals with depressions persevere through Winter by telling themselves they will feel relief in the Spring. Too often the coming of Spring brings not reprieve but a deadly combination of deeper mental desperation coupled with the release from winter lassitude that energizes the now hopeless person to put ideation into action.4,9 The elevation of suicide rates in Spring is likely multidetermined with all these putative causes contributing in different variations to every individual who tragically dies by suicide.

Yet despite decades of public education, this dangerous fiction stubbornly persists in the educated public and even among many health care professionals, in part due to misguided media. For years, the Annenberg Public Policy Center (APPC) has made busting this myth of holiday suicides in the media an organizational initiative. A 2023 APPC survey found that 4 of 5 Americans picked December as the month when suicide rates were highest. The organization has been analyzing holiday—related media reports for decades; those results show some improvement, with the most recent analysis of media reports somewhat better and 40% communicating erroneous information. 10

APPC believes the opinion that suicide is more common around the holidays will persuade those struggling with an exacerbation of a mental health condition or an acute crisis to attempt or die by suicide, believing it to be a reasonable social response. While recognizing there is a real risk of such contagion behavior, I believe the reverse problem is more concerning. As I observed during my internship, the acceptance of the fiction that everyone is happy in Spring may even blind health care professionals from detecting clues that patients and even our loved ones are contemplating suicide. Our relief that Winter has passed and enjoyment of Spring activities can fool us into believing everyone else is also feeling fine and doing well and miss an opportunity to intervene and treat mania or depression to save a life—the medical manifestation of renewal.

April is the cruellest month, breeding
Lilacs out of the dead land, mixing
Memory and desire, stirring
Dull roots with spring rain.
T.S. Eliot1

The epigraph for this column is from The Waste Land, T.S. Eliot’s postmodern poem that, in part, reflects his experience of the destruction of an entire way of living and a generation of young men in the wake of the First World War. The terrible contemporary toll suicide has taken on veterans and the active-duty military makes it easy to forget that suicide is an inveterate and disturbing aftermath of all wars.2

There is a profound and elemental connection in the human mind between Spring and renewal. In almost every culture and religion, across nearly every historical epoch and location, Spring is associated with themes of growth, returning life, light, and hope. On a more prosaic modern level, almost all of us—us—especially those in Northern climates—look forward to warmer weather, more time spent outdoors, and the simple joys of seeing perennials return in the garden and birds nest in blooming trees.

It is a paradox of human life that suicide is more common in the season of rebirth than in the season of decline. The bare trees, freezing temperatures, and icy darkness that accompany winter in much of the world inherently lead us to contemplate our mortality. The counterintuitive finding that individuals, many of them veterans, take their own lives more often in Spring creates a cognitive dissonance to be explored in this editorial.

As a layperson, I too assumed there were more suicides in winter, especially around the holidays when the expectation of belonging, privilege, and pleasure painfully reminds the alienated, lonely, homeless, and ailing of all they lack and all they have lost. As a psychiatric intern, I anticipated that the inpatient US Department of Veterans Affairs (VA) ward where I was training would empty with the arrival of nicer weather. Instead, I was mystified when the opposite occurred and the unit was overflowing with manic and suicidal patients.

The Centers for Disease Control and Prevention National Center for Health Statistics ranked suicide by month from 1999 to 2010. Contrary to popular belief, more suicides occurred in late Spring and Summer than any other season.3 A 2023 study of systematic reviews of seasonal variation in mood disorders, suicide risk, and health care utilization found that suicide was 11% to 23% higher, suicide attempts resulting in emergency department visits showed an increase of 1.2% to 1.7%, and hospital admissions for mania rose 7.4% to 16.0% in Spring and Summer, compared with Fall and Winter.4 This general population finding is also seen in veteran and military cohorts. A recent study analyzed VA and US Department of Defense (DoD) data from 133,867 veteran suicides from 2001 to 2021. Results showed that veteran suicides were highest in Summer.5

The rise of suicide in the Spring was first observed in the 17th century and has been the object of scientific study for at least 3 decades. That research has produced several different hypotheses from a variety of disciplines, none of which are conclusive as of this writing. Cho and Lee note that the phrase “Spring fever” is a much more serious illness for those with a predisposition or diagnosis of unipolar or bipolar disorder than the quotidian irritant that afflicts those without affective disorders.6 In residency, I learned that longer exposure to light in Spring led to an imbalance in neurotransmitters that triggered manias. This is a simplistic version of the complex circadian interactions of temperature, climate, light, and other environmental variables causing dysregulation or misalignment of our natural biological cycles and those of nature proposed by chronobiologists.7

Sociological and criminal justice scholars underscore that an increase in temperature may exacerbate violent tendencies, especially in older males—a demographic profile more frequently found in veterans—and those already prone to acting out their frustrations with firearms.8 Psychologists have hypothesized that individuals with depressions persevere through Winter by telling themselves they will feel relief in the Spring. Too often the coming of Spring brings not reprieve but a deadly combination of deeper mental desperation coupled with the release from winter lassitude that energizes the now hopeless person to put ideation into action.4,9 The elevation of suicide rates in Spring is likely multidetermined with all these putative causes contributing in different variations to every individual who tragically dies by suicide.

Yet despite decades of public education, this dangerous fiction stubbornly persists in the educated public and even among many health care professionals, in part due to misguided media. For years, the Annenberg Public Policy Center (APPC) has made busting this myth of holiday suicides in the media an organizational initiative. A 2023 APPC survey found that 4 of 5 Americans picked December as the month when suicide rates were highest. The organization has been analyzing holiday—related media reports for decades; those results show some improvement, with the most recent analysis of media reports somewhat better and 40% communicating erroneous information. 10

APPC believes the opinion that suicide is more common around the holidays will persuade those struggling with an exacerbation of a mental health condition or an acute crisis to attempt or die by suicide, believing it to be a reasonable social response. While recognizing there is a real risk of such contagion behavior, I believe the reverse problem is more concerning. As I observed during my internship, the acceptance of the fiction that everyone is happy in Spring may even blind health care professionals from detecting clues that patients and even our loved ones are contemplating suicide. Our relief that Winter has passed and enjoyment of Spring activities can fool us into believing everyone else is also feeling fine and doing well and miss an opportunity to intervene and treat mania or depression to save a life—the medical manifestation of renewal.

References
  1. Elliot TS, North M. The Waste Land and Other Poems: A Norton Critical Edition. W.W. Norton & Company; 2022.
  2. Lester D. Suicide rates before, during, and after the world wars. Eur Psychiatry. 1994;9(5):262-264. doi:10.1017/S092493380000362X
  3. Centers for Disease Control Center and Prevention. National Center for Health Statistics. Fact or fiction: suicides increase during the holiday season and winter months. January 10, 2014. Accessed March 27, 2025. https://blogs.cdc.gov/nchs/2014/01/10/1121/
  4. Della DF, Allison S, Bidargaddi N, Wa SK, Bastiampillai T. An umbrella systematic review of seasonality in mood disorders and suicide risk: the impact on demand for primary behavioral health care and acute psychiatric services. Prim Care Companion CNS Disord. 2023;25(3):22r03395. doi:10.4088/PCC.22r03395
  5. Gold SA, Goodrich M, Morley SW, Stephens B, McCarthy JF. Temporal patterns of veteran suicide: variation by season, day of the week, and holidays. Suicide Life Threat Behav. 2025;55(2):e13148. doi:10.1111/sltb.13148
  6. Cho CH, Lee HJ. Why do mania and suicide occur most often in the Spring? Psychiatry Investig. 2018;15(3):232-234. doi:10.30773/pi.2017.12.20
  7. Postolache TT, Mortensen PB, Tonelli LH, et al. Seasonal spring peaks of suicide in victims with and without prior history of hospitalization for mood disorders. J Affect Disord. 2010;121(1-2):88-93. doi:10.1016/j.jad.2009.05.015
  8. Christodoulou C, Efstathiou V, Bouras G, Korkoliakou P, Lykouras L. Seasonal variation of suicide: a brief review. Encephalos. 2012;49:73-79.
  9. Shapiro M. Suicide rates spike in spring, not winter. Dome. May/June 2019. Accessed March 28, 2025. https://www.hopkinsmedicine.org/news/articles/2019/05/suicide-rates-spike-in-spring-not-winter
  10. Annenberg Public Policy Center. Suicides don’t spike around the holiday season, but Americans think they do. December 6, 2023. Accessed March 27, 2025. https:// www.asc.upenn.edu/news-events/news/suicides-dont-spike-around-holiday-season-americans-think-they-do
References
  1. Elliot TS, North M. The Waste Land and Other Poems: A Norton Critical Edition. W.W. Norton & Company; 2022.
  2. Lester D. Suicide rates before, during, and after the world wars. Eur Psychiatry. 1994;9(5):262-264. doi:10.1017/S092493380000362X
  3. Centers for Disease Control Center and Prevention. National Center for Health Statistics. Fact or fiction: suicides increase during the holiday season and winter months. January 10, 2014. Accessed March 27, 2025. https://blogs.cdc.gov/nchs/2014/01/10/1121/
  4. Della DF, Allison S, Bidargaddi N, Wa SK, Bastiampillai T. An umbrella systematic review of seasonality in mood disorders and suicide risk: the impact on demand for primary behavioral health care and acute psychiatric services. Prim Care Companion CNS Disord. 2023;25(3):22r03395. doi:10.4088/PCC.22r03395
  5. Gold SA, Goodrich M, Morley SW, Stephens B, McCarthy JF. Temporal patterns of veteran suicide: variation by season, day of the week, and holidays. Suicide Life Threat Behav. 2025;55(2):e13148. doi:10.1111/sltb.13148
  6. Cho CH, Lee HJ. Why do mania and suicide occur most often in the Spring? Psychiatry Investig. 2018;15(3):232-234. doi:10.30773/pi.2017.12.20
  7. Postolache TT, Mortensen PB, Tonelli LH, et al. Seasonal spring peaks of suicide in victims with and without prior history of hospitalization for mood disorders. J Affect Disord. 2010;121(1-2):88-93. doi:10.1016/j.jad.2009.05.015
  8. Christodoulou C, Efstathiou V, Bouras G, Korkoliakou P, Lykouras L. Seasonal variation of suicide: a brief review. Encephalos. 2012;49:73-79.
  9. Shapiro M. Suicide rates spike in spring, not winter. Dome. May/June 2019. Accessed March 28, 2025. https://www.hopkinsmedicine.org/news/articles/2019/05/suicide-rates-spike-in-spring-not-winter
  10. Annenberg Public Policy Center. Suicides don’t spike around the holiday season, but Americans think they do. December 6, 2023. Accessed March 27, 2025. https:// www.asc.upenn.edu/news-events/news/suicides-dont-spike-around-holiday-season-americans-think-they-do
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The Unholy Trinity: Unlawful Prescriptions, False Claims, and Dangerous Drugs

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The Unholy Trinity: Unlawful Prescriptions, False Claims, and Dangerous Drugs

Express Scripts, the contractor that manages the pharmacy benefit for Tricare, the military health insurance program, announced in 2021 that after a 5-year absence, CVS Pharmacy was once more in the network. In 2023, CVS had the largest profits of any pharmacy chain in the United States, about $159 billion, and generated a quarter of the overall revenue of the US pharmacy industry.1 Tricare officials heralded the return of CVS as a move that would offer US Department of Defense (DoD) beneficiaries more competitive prices, convenient access, and overall quality.2

DOJ Files Lawsuit Against CVS

In December 2024, the US Department of Justice (DoJ) filed a lawsuit alleging that CVS violated both the Controlled Substances Act (CSA) and the False Claims Act (FCA).3,4 The United States ex rel. Estright v Health Corporation, et al, filed in Rhode Island, charged that CVS “routinely” and “knowingly” filled invalid prescriptions for controlled substances violating the CSA and then billed federal health care programs for payment for these prescriptions, a breach of the FCA.5 The DoJ alleged that CVS pharmacies and pharmacists filled prescriptions for controlled substances that (1) lacked a legitimate medical purpose; (2) were not legally valid; and/or (3) were not issued in the usual course of medical practice. 6 CVS contests the charges and issued an official response, stating that it disputes the allegations as false, plans to disprove them in litigation, and has nonetheless fully cooperated with the investigation.7

The allegations involved prescriptions for drugs like opioids and benzodiazepines, primary culprits in the American overdose epidemic.8 The complaint notes that the prescriptions were early refills in excessive quantities and included what has been called the “holy trinity” of dangerous medications: opioids, benzodiazepines, and muscle relaxants. 5,8 Even worse (if that is possible), as the complaint outlines, CVS had access to data from both inside and outside the company that these prescriptions came from notorious pill mills and were hence unlawful and yet continued to fill them, leading the DoJ to file the more serious charge that the corporation “knowingly” violated the CSA and “prioritized profits over safety in dispensing controlled substances.”5,6

The Unholy Trinity

The infamous members of what I prefer to call the “unholy trinity” are a benzodiazepine, often alprazolam, an opioid, and the muscle relaxant carisoprodol. The combination amplifies each agent’s independent risk of respiratory depression. The latter is a schedule IV medication with an active metabolite, meprobamate, that also has this adverse effect. All 3 drugs have high abuse potential and, when combined, increase the risk of fatal overdose. The colloquial name holy trinity derives from the synergistic euphoria experienced when taking this triple cocktail of sedative agents.9 This pharmacological recipe for disaster is the house specialty of pill mills: infamous storefront practices that generate high profits and exploit persons with chronic pain and addiction by handing out controlled substances with little clinical assessment and even less oversight.10

When the Means Become the End

The DoJ allegations suggest that the violations resulted from “corporate-mandated performance metrics, incentive compensation, and staffing policies that prioritized corporate profits over patient safety.”6 If the allegations are true, why would a company reinvited by Tricare to serve the nation’s heroes seemingly engage in illegal practices? While CVS has not responded in court, their statement argued that “too often, we have seen government agencies and trial lawyers question the good-faith decisions made by pharmacists while a patient waits at the pharmacy counter, often in pain.”6

The DoJ complaint offers a cautionary warning for the US health care system, which is increasingly being micromanaged in the pursuit of efficiency. Like many practitioners in and out of the federal system, I get a cold chill when I read the word productivity. “CVS pharmacists described working at CVS as ‘soul crushing’ because it was impossible to meet the company’s expectations,” the complaint alleges, because “CVS set staffing levels so low that it was impossible for pharmacists to comply with their legal obligations and meet CVS’s demanding metrics.”5 Did top-down mandates drive the alleged activities by imposing unattainable performance metrics on pharmacists, offering incentives that encouraged and rewarded corner-cutting, and refusing to fund sufficient staffing to ensure patient safety? This may be what happens when the means (efficiency) become the end rather than a mechanism to achieve the goal of more accessible, affordable, high-quality health care.

Ethically, what is most concerning is that leadership intentionally “deprived its pharmacists of crucial information” about specific practitioners known to engage in illegal prescribing practices.6 CVS did not provide pharmacists with “information about prescribers’ prescribing habits that CVS routinely collected and reviewed at the corporate level,” and even removed prescriber blocks that were implemented at Target pharmacies before it was acquired by CVS.5 The first element of informed consent is providing patients with adequate information upon which to decide whether to accept or decline treatment. 11 In this situation, however, CVS allegedly prevented “pharmacists from warning one another about certain prescribers.”6

If true, the company deprived frontline pharmacists of the information they needed to safely and responsibly dispense medications: “The practices alleged contributed to the opioid crisis and opioid-related deaths, and today’s complaint seeks to hold CVS accountable for its misconduct.”6 Though the cost in human life that may have resulted from CSA violations must absolutely and always outweigh financial considerations, the economic damage to Tricare from fraudulent billing and the betrayal of its fiduciary responsinility cannot be underestimated.

A Corporate Morality Play

CVS is not the only company, nor is pharmacy the only industry in health care, that has been the subject of watchdog agency lawsuits or variegated forms of wrongdoing, including violations of the CSA and FCA.10,12 As of this writing, the DoJ case against CVS has not been heard, much less adjudicated in a court of law. It is ironic that both the DoJ claims and the CVS rebuttal describe the manifest conflict of obligation that pharmacists confront between protecting their livelihood and safeguarding patients’ lives as suggested in the epigraph that has been attributed to the 19th-century British physician and medical educator Peter Mere Latham. It is a dilemma that a growing number of health care practitioners face daily in a vocation becoming increasingly commercialized. It is all too easy for an individual physician, nurse, or pharmacist to feel hopeless and helpless before the behemoth might of a large and looming entity. Yet, it was a whistleblower whose moral courage led to the DoJ investigation and subsequent charges.13 We must all never doubt the power of a committed person of conscience to withstand the pressure to mutate medications into poison and stand up for the principles of our professions and inspire a community of colleagues to follow their example.

References
  1. Fein AJ. The Top U.S. pharmacy markets of 2023: market shares and revenues at the biggest chains and PBMs. Drug Channels. March 12, 2024. Accessed February 24, 2025. https://www.drugchannels.net/2024/03/the-top-15-us-pharmacies-of-2023-market.html
  2. Jowers K. CVS returns to the military Tricare network. Walmart’s out. Military Times. October 18, 2021. Accessed February 24, 2025. https://www.militarytimes.com/pay-benefits/mil-money/2021/10/28/cvs-returns-to-the-military-tricare-pharmacy-network-walmarts-out/
  3. False Claims, 31 USC § 3729 (2009). Accessed February 24, 2025. https://www.govinfo.gov/content/pkg/USCODE-2011-title31/pdf/USCODE-2011-title31-subtitleIII-chap37-subchapIII-sec3729.pdf
  4. Drug Abuse Prevention and Control, Control and Enforcement, 21 USC 13 § 801 (2022). Accessed February 24, 2025. https://www.govinfo.gov/app/details/USCODE-2021-title21/USCODE-2021-title21-chap13-subchapI-partA-sec801
  5. United States ex rel. Estright v Health Corporation, et al. Accessed February 26, 2025. https://www.justice.gov/archives/opa/media/1381111/dl
  6. US Department of Justice. Justice Department files nationwide lawsuit alleging CVS knowingly dispensed controlled substances in violation of the Controlled Substances ACT and the False Claims Act. News release. December 18, 2024. Accessed February 24, 2025. https://www.justice.gov/archives/opa/pr/justice-department-files-nationwide-lawsuit-alleging-cvs-knowingly-dispensed-controlled
  7. CVS Health. CVS Health statement regarding the U.S. Department of Justice’s lawsuit against CVS pharmacy. News release. December 18, 2024. Accessed February 24, 2025. https://www.cvshealth.com/impact/healthy-community/our-opioid-response.html
  8. Park TW, Saitz R, Ganoczy D, Ilgen MA, Bohnert AS. Benzodiazepine prescribing patterns and deaths from drug overdose among US veterans receiving opioid analgesics: case-cohort study. BMJ. 2015;350:h2698. doi:10.1136/bmj.h2698
  9. Wang Y, Delcher C, Li Y, Goldberger BA, Reisfield GM. Overlapping prescriptions of opioids, benzodiazepines, and carisoprodol: “Holy Trinity” prescribing in the state of Florida. Drug Alcohol Depend. 2019;205:107693. doi:10.1016/j.drugalcdep.2019.107693
  10. Wolf AA. The perfect storm: opioid risks and ‘The Holy Trinity’. Pharmacy Times. September 24, 2014. Accessed February 24, 2025. https://www.pharmacytimes.com/view/the-perfect-storm-opioid-risks-and-the-holy-trinity
  11. The meaning and justification of informed consent. In: Beauchamp TL, Childress JF. Principles of Biomedical Ethics. Eighth Edition. Oxford University Press; 2019:118-123.
  12. US Department of Justice. OptumRX agrees to pay $20M to resolve allegations that it filled certain opioid prescriptions in violation of the Controlled Substances Act. News release. June 27, 2024. Accessed February 24, 2025. https://www.justice.gov/archives/opa/pr/optumrx-agrees-pay-20m-resolve-allegations-it-filled-certain-opioid-prescriptions-violation
  13. US Department of Justice. False Claims Act settlements and judgments exceed $2.9B in fiscal year 2024. News release. January 15, 2025. Accessed February 24, 2025. https://www.justice.gov/archives/opa/pr/false-claims-act-settlements-and-judgments-exceed-29b-fiscal-year-2024
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Express Scripts, the contractor that manages the pharmacy benefit for Tricare, the military health insurance program, announced in 2021 that after a 5-year absence, CVS Pharmacy was once more in the network. In 2023, CVS had the largest profits of any pharmacy chain in the United States, about $159 billion, and generated a quarter of the overall revenue of the US pharmacy industry.1 Tricare officials heralded the return of CVS as a move that would offer US Department of Defense (DoD) beneficiaries more competitive prices, convenient access, and overall quality.2

DOJ Files Lawsuit Against CVS

In December 2024, the US Department of Justice (DoJ) filed a lawsuit alleging that CVS violated both the Controlled Substances Act (CSA) and the False Claims Act (FCA).3,4 The United States ex rel. Estright v Health Corporation, et al, filed in Rhode Island, charged that CVS “routinely” and “knowingly” filled invalid prescriptions for controlled substances violating the CSA and then billed federal health care programs for payment for these prescriptions, a breach of the FCA.5 The DoJ alleged that CVS pharmacies and pharmacists filled prescriptions for controlled substances that (1) lacked a legitimate medical purpose; (2) were not legally valid; and/or (3) were not issued in the usual course of medical practice. 6 CVS contests the charges and issued an official response, stating that it disputes the allegations as false, plans to disprove them in litigation, and has nonetheless fully cooperated with the investigation.7

The allegations involved prescriptions for drugs like opioids and benzodiazepines, primary culprits in the American overdose epidemic.8 The complaint notes that the prescriptions were early refills in excessive quantities and included what has been called the “holy trinity” of dangerous medications: opioids, benzodiazepines, and muscle relaxants. 5,8 Even worse (if that is possible), as the complaint outlines, CVS had access to data from both inside and outside the company that these prescriptions came from notorious pill mills and were hence unlawful and yet continued to fill them, leading the DoJ to file the more serious charge that the corporation “knowingly” violated the CSA and “prioritized profits over safety in dispensing controlled substances.”5,6

The Unholy Trinity

The infamous members of what I prefer to call the “unholy trinity” are a benzodiazepine, often alprazolam, an opioid, and the muscle relaxant carisoprodol. The combination amplifies each agent’s independent risk of respiratory depression. The latter is a schedule IV medication with an active metabolite, meprobamate, that also has this adverse effect. All 3 drugs have high abuse potential and, when combined, increase the risk of fatal overdose. The colloquial name holy trinity derives from the synergistic euphoria experienced when taking this triple cocktail of sedative agents.9 This pharmacological recipe for disaster is the house specialty of pill mills: infamous storefront practices that generate high profits and exploit persons with chronic pain and addiction by handing out controlled substances with little clinical assessment and even less oversight.10

When the Means Become the End

The DoJ allegations suggest that the violations resulted from “corporate-mandated performance metrics, incentive compensation, and staffing policies that prioritized corporate profits over patient safety.”6 If the allegations are true, why would a company reinvited by Tricare to serve the nation’s heroes seemingly engage in illegal practices? While CVS has not responded in court, their statement argued that “too often, we have seen government agencies and trial lawyers question the good-faith decisions made by pharmacists while a patient waits at the pharmacy counter, often in pain.”6

The DoJ complaint offers a cautionary warning for the US health care system, which is increasingly being micromanaged in the pursuit of efficiency. Like many practitioners in and out of the federal system, I get a cold chill when I read the word productivity. “CVS pharmacists described working at CVS as ‘soul crushing’ because it was impossible to meet the company’s expectations,” the complaint alleges, because “CVS set staffing levels so low that it was impossible for pharmacists to comply with their legal obligations and meet CVS’s demanding metrics.”5 Did top-down mandates drive the alleged activities by imposing unattainable performance metrics on pharmacists, offering incentives that encouraged and rewarded corner-cutting, and refusing to fund sufficient staffing to ensure patient safety? This may be what happens when the means (efficiency) become the end rather than a mechanism to achieve the goal of more accessible, affordable, high-quality health care.

Ethically, what is most concerning is that leadership intentionally “deprived its pharmacists of crucial information” about specific practitioners known to engage in illegal prescribing practices.6 CVS did not provide pharmacists with “information about prescribers’ prescribing habits that CVS routinely collected and reviewed at the corporate level,” and even removed prescriber blocks that were implemented at Target pharmacies before it was acquired by CVS.5 The first element of informed consent is providing patients with adequate information upon which to decide whether to accept or decline treatment. 11 In this situation, however, CVS allegedly prevented “pharmacists from warning one another about certain prescribers.”6

If true, the company deprived frontline pharmacists of the information they needed to safely and responsibly dispense medications: “The practices alleged contributed to the opioid crisis and opioid-related deaths, and today’s complaint seeks to hold CVS accountable for its misconduct.”6 Though the cost in human life that may have resulted from CSA violations must absolutely and always outweigh financial considerations, the economic damage to Tricare from fraudulent billing and the betrayal of its fiduciary responsinility cannot be underestimated.

A Corporate Morality Play

CVS is not the only company, nor is pharmacy the only industry in health care, that has been the subject of watchdog agency lawsuits or variegated forms of wrongdoing, including violations of the CSA and FCA.10,12 As of this writing, the DoJ case against CVS has not been heard, much less adjudicated in a court of law. It is ironic that both the DoJ claims and the CVS rebuttal describe the manifest conflict of obligation that pharmacists confront between protecting their livelihood and safeguarding patients’ lives as suggested in the epigraph that has been attributed to the 19th-century British physician and medical educator Peter Mere Latham. It is a dilemma that a growing number of health care practitioners face daily in a vocation becoming increasingly commercialized. It is all too easy for an individual physician, nurse, or pharmacist to feel hopeless and helpless before the behemoth might of a large and looming entity. Yet, it was a whistleblower whose moral courage led to the DoJ investigation and subsequent charges.13 We must all never doubt the power of a committed person of conscience to withstand the pressure to mutate medications into poison and stand up for the principles of our professions and inspire a community of colleagues to follow their example.

Express Scripts, the contractor that manages the pharmacy benefit for Tricare, the military health insurance program, announced in 2021 that after a 5-year absence, CVS Pharmacy was once more in the network. In 2023, CVS had the largest profits of any pharmacy chain in the United States, about $159 billion, and generated a quarter of the overall revenue of the US pharmacy industry.1 Tricare officials heralded the return of CVS as a move that would offer US Department of Defense (DoD) beneficiaries more competitive prices, convenient access, and overall quality.2

DOJ Files Lawsuit Against CVS

In December 2024, the US Department of Justice (DoJ) filed a lawsuit alleging that CVS violated both the Controlled Substances Act (CSA) and the False Claims Act (FCA).3,4 The United States ex rel. Estright v Health Corporation, et al, filed in Rhode Island, charged that CVS “routinely” and “knowingly” filled invalid prescriptions for controlled substances violating the CSA and then billed federal health care programs for payment for these prescriptions, a breach of the FCA.5 The DoJ alleged that CVS pharmacies and pharmacists filled prescriptions for controlled substances that (1) lacked a legitimate medical purpose; (2) were not legally valid; and/or (3) were not issued in the usual course of medical practice. 6 CVS contests the charges and issued an official response, stating that it disputes the allegations as false, plans to disprove them in litigation, and has nonetheless fully cooperated with the investigation.7

The allegations involved prescriptions for drugs like opioids and benzodiazepines, primary culprits in the American overdose epidemic.8 The complaint notes that the prescriptions were early refills in excessive quantities and included what has been called the “holy trinity” of dangerous medications: opioids, benzodiazepines, and muscle relaxants. 5,8 Even worse (if that is possible), as the complaint outlines, CVS had access to data from both inside and outside the company that these prescriptions came from notorious pill mills and were hence unlawful and yet continued to fill them, leading the DoJ to file the more serious charge that the corporation “knowingly” violated the CSA and “prioritized profits over safety in dispensing controlled substances.”5,6

The Unholy Trinity

The infamous members of what I prefer to call the “unholy trinity” are a benzodiazepine, often alprazolam, an opioid, and the muscle relaxant carisoprodol. The combination amplifies each agent’s independent risk of respiratory depression. The latter is a schedule IV medication with an active metabolite, meprobamate, that also has this adverse effect. All 3 drugs have high abuse potential and, when combined, increase the risk of fatal overdose. The colloquial name holy trinity derives from the synergistic euphoria experienced when taking this triple cocktail of sedative agents.9 This pharmacological recipe for disaster is the house specialty of pill mills: infamous storefront practices that generate high profits and exploit persons with chronic pain and addiction by handing out controlled substances with little clinical assessment and even less oversight.10

When the Means Become the End

The DoJ allegations suggest that the violations resulted from “corporate-mandated performance metrics, incentive compensation, and staffing policies that prioritized corporate profits over patient safety.”6 If the allegations are true, why would a company reinvited by Tricare to serve the nation’s heroes seemingly engage in illegal practices? While CVS has not responded in court, their statement argued that “too often, we have seen government agencies and trial lawyers question the good-faith decisions made by pharmacists while a patient waits at the pharmacy counter, often in pain.”6

The DoJ complaint offers a cautionary warning for the US health care system, which is increasingly being micromanaged in the pursuit of efficiency. Like many practitioners in and out of the federal system, I get a cold chill when I read the word productivity. “CVS pharmacists described working at CVS as ‘soul crushing’ because it was impossible to meet the company’s expectations,” the complaint alleges, because “CVS set staffing levels so low that it was impossible for pharmacists to comply with their legal obligations and meet CVS’s demanding metrics.”5 Did top-down mandates drive the alleged activities by imposing unattainable performance metrics on pharmacists, offering incentives that encouraged and rewarded corner-cutting, and refusing to fund sufficient staffing to ensure patient safety? This may be what happens when the means (efficiency) become the end rather than a mechanism to achieve the goal of more accessible, affordable, high-quality health care.

Ethically, what is most concerning is that leadership intentionally “deprived its pharmacists of crucial information” about specific practitioners known to engage in illegal prescribing practices.6 CVS did not provide pharmacists with “information about prescribers’ prescribing habits that CVS routinely collected and reviewed at the corporate level,” and even removed prescriber blocks that were implemented at Target pharmacies before it was acquired by CVS.5 The first element of informed consent is providing patients with adequate information upon which to decide whether to accept or decline treatment. 11 In this situation, however, CVS allegedly prevented “pharmacists from warning one another about certain prescribers.”6

If true, the company deprived frontline pharmacists of the information they needed to safely and responsibly dispense medications: “The practices alleged contributed to the opioid crisis and opioid-related deaths, and today’s complaint seeks to hold CVS accountable for its misconduct.”6 Though the cost in human life that may have resulted from CSA violations must absolutely and always outweigh financial considerations, the economic damage to Tricare from fraudulent billing and the betrayal of its fiduciary responsinility cannot be underestimated.

A Corporate Morality Play

CVS is not the only company, nor is pharmacy the only industry in health care, that has been the subject of watchdog agency lawsuits or variegated forms of wrongdoing, including violations of the CSA and FCA.10,12 As of this writing, the DoJ case against CVS has not been heard, much less adjudicated in a court of law. It is ironic that both the DoJ claims and the CVS rebuttal describe the manifest conflict of obligation that pharmacists confront between protecting their livelihood and safeguarding patients’ lives as suggested in the epigraph that has been attributed to the 19th-century British physician and medical educator Peter Mere Latham. It is a dilemma that a growing number of health care practitioners face daily in a vocation becoming increasingly commercialized. It is all too easy for an individual physician, nurse, or pharmacist to feel hopeless and helpless before the behemoth might of a large and looming entity. Yet, it was a whistleblower whose moral courage led to the DoJ investigation and subsequent charges.13 We must all never doubt the power of a committed person of conscience to withstand the pressure to mutate medications into poison and stand up for the principles of our professions and inspire a community of colleagues to follow their example.

References
  1. Fein AJ. The Top U.S. pharmacy markets of 2023: market shares and revenues at the biggest chains and PBMs. Drug Channels. March 12, 2024. Accessed February 24, 2025. https://www.drugchannels.net/2024/03/the-top-15-us-pharmacies-of-2023-market.html
  2. Jowers K. CVS returns to the military Tricare network. Walmart’s out. Military Times. October 18, 2021. Accessed February 24, 2025. https://www.militarytimes.com/pay-benefits/mil-money/2021/10/28/cvs-returns-to-the-military-tricare-pharmacy-network-walmarts-out/
  3. False Claims, 31 USC § 3729 (2009). Accessed February 24, 2025. https://www.govinfo.gov/content/pkg/USCODE-2011-title31/pdf/USCODE-2011-title31-subtitleIII-chap37-subchapIII-sec3729.pdf
  4. Drug Abuse Prevention and Control, Control and Enforcement, 21 USC 13 § 801 (2022). Accessed February 24, 2025. https://www.govinfo.gov/app/details/USCODE-2021-title21/USCODE-2021-title21-chap13-subchapI-partA-sec801
  5. United States ex rel. Estright v Health Corporation, et al. Accessed February 26, 2025. https://www.justice.gov/archives/opa/media/1381111/dl
  6. US Department of Justice. Justice Department files nationwide lawsuit alleging CVS knowingly dispensed controlled substances in violation of the Controlled Substances ACT and the False Claims Act. News release. December 18, 2024. Accessed February 24, 2025. https://www.justice.gov/archives/opa/pr/justice-department-files-nationwide-lawsuit-alleging-cvs-knowingly-dispensed-controlled
  7. CVS Health. CVS Health statement regarding the U.S. Department of Justice’s lawsuit against CVS pharmacy. News release. December 18, 2024. Accessed February 24, 2025. https://www.cvshealth.com/impact/healthy-community/our-opioid-response.html
  8. Park TW, Saitz R, Ganoczy D, Ilgen MA, Bohnert AS. Benzodiazepine prescribing patterns and deaths from drug overdose among US veterans receiving opioid analgesics: case-cohort study. BMJ. 2015;350:h2698. doi:10.1136/bmj.h2698
  9. Wang Y, Delcher C, Li Y, Goldberger BA, Reisfield GM. Overlapping prescriptions of opioids, benzodiazepines, and carisoprodol: “Holy Trinity” prescribing in the state of Florida. Drug Alcohol Depend. 2019;205:107693. doi:10.1016/j.drugalcdep.2019.107693
  10. Wolf AA. The perfect storm: opioid risks and ‘The Holy Trinity’. Pharmacy Times. September 24, 2014. Accessed February 24, 2025. https://www.pharmacytimes.com/view/the-perfect-storm-opioid-risks-and-the-holy-trinity
  11. The meaning and justification of informed consent. In: Beauchamp TL, Childress JF. Principles of Biomedical Ethics. Eighth Edition. Oxford University Press; 2019:118-123.
  12. US Department of Justice. OptumRX agrees to pay $20M to resolve allegations that it filled certain opioid prescriptions in violation of the Controlled Substances Act. News release. June 27, 2024. Accessed February 24, 2025. https://www.justice.gov/archives/opa/pr/optumrx-agrees-pay-20m-resolve-allegations-it-filled-certain-opioid-prescriptions-violation
  13. US Department of Justice. False Claims Act settlements and judgments exceed $2.9B in fiscal year 2024. News release. January 15, 2025. Accessed February 24, 2025. https://www.justice.gov/archives/opa/pr/false-claims-act-settlements-and-judgments-exceed-29b-fiscal-year-2024
References
  1. Fein AJ. The Top U.S. pharmacy markets of 2023: market shares and revenues at the biggest chains and PBMs. Drug Channels. March 12, 2024. Accessed February 24, 2025. https://www.drugchannels.net/2024/03/the-top-15-us-pharmacies-of-2023-market.html
  2. Jowers K. CVS returns to the military Tricare network. Walmart’s out. Military Times. October 18, 2021. Accessed February 24, 2025. https://www.militarytimes.com/pay-benefits/mil-money/2021/10/28/cvs-returns-to-the-military-tricare-pharmacy-network-walmarts-out/
  3. False Claims, 31 USC § 3729 (2009). Accessed February 24, 2025. https://www.govinfo.gov/content/pkg/USCODE-2011-title31/pdf/USCODE-2011-title31-subtitleIII-chap37-subchapIII-sec3729.pdf
  4. Drug Abuse Prevention and Control, Control and Enforcement, 21 USC 13 § 801 (2022). Accessed February 24, 2025. https://www.govinfo.gov/app/details/USCODE-2021-title21/USCODE-2021-title21-chap13-subchapI-partA-sec801
  5. United States ex rel. Estright v Health Corporation, et al. Accessed February 26, 2025. https://www.justice.gov/archives/opa/media/1381111/dl
  6. US Department of Justice. Justice Department files nationwide lawsuit alleging CVS knowingly dispensed controlled substances in violation of the Controlled Substances ACT and the False Claims Act. News release. December 18, 2024. Accessed February 24, 2025. https://www.justice.gov/archives/opa/pr/justice-department-files-nationwide-lawsuit-alleging-cvs-knowingly-dispensed-controlled
  7. CVS Health. CVS Health statement regarding the U.S. Department of Justice’s lawsuit against CVS pharmacy. News release. December 18, 2024. Accessed February 24, 2025. https://www.cvshealth.com/impact/healthy-community/our-opioid-response.html
  8. Park TW, Saitz R, Ganoczy D, Ilgen MA, Bohnert AS. Benzodiazepine prescribing patterns and deaths from drug overdose among US veterans receiving opioid analgesics: case-cohort study. BMJ. 2015;350:h2698. doi:10.1136/bmj.h2698
  9. Wang Y, Delcher C, Li Y, Goldberger BA, Reisfield GM. Overlapping prescriptions of opioids, benzodiazepines, and carisoprodol: “Holy Trinity” prescribing in the state of Florida. Drug Alcohol Depend. 2019;205:107693. doi:10.1016/j.drugalcdep.2019.107693
  10. Wolf AA. The perfect storm: opioid risks and ‘The Holy Trinity’. Pharmacy Times. September 24, 2014. Accessed February 24, 2025. https://www.pharmacytimes.com/view/the-perfect-storm-opioid-risks-and-the-holy-trinity
  11. The meaning and justification of informed consent. In: Beauchamp TL, Childress JF. Principles of Biomedical Ethics. Eighth Edition. Oxford University Press; 2019:118-123.
  12. US Department of Justice. OptumRX agrees to pay $20M to resolve allegations that it filled certain opioid prescriptions in violation of the Controlled Substances Act. News release. June 27, 2024. Accessed February 24, 2025. https://www.justice.gov/archives/opa/pr/optumrx-agrees-pay-20m-resolve-allegations-it-filled-certain-opioid-prescriptions-violation
  13. US Department of Justice. False Claims Act settlements and judgments exceed $2.9B in fiscal year 2024. News release. January 15, 2025. Accessed February 24, 2025. https://www.justice.gov/archives/opa/pr/false-claims-act-settlements-and-judgments-exceed-29b-fiscal-year-2024
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The Unholy Trinity: Unlawful Prescriptions, False Claims, and Dangerous Drugs

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The Heart Matters: Women Veterans, Cardiovascular Disease, and PTSD

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The Heart Matters: Women Veterans, Cardiovascular Disease, and PTSD

If I can stop one heart from breaking, I shall not live in vain.
Emily Dickinson1

The celebration of Valentine’s Day has made the association of hearts with the month of February almost automatic. There is, though, another commemoration of hearts in the second month of the year with special significance for federal practice: American Heart Month. President Lyndon B. Johnson proclaimed February as American Heart Month in 1964 to raise awareness of the enormous human and economic cost of cardiovascular diseases (CVD) that impact many Americans in their prime.

The Centers for Disease Control and Prevention estimates that 1 in 5 deaths in the United States is due to CVD, which includes coronary artery disease, heart failure, heart attack, and stroke.2 American Heart Month aims to increase public attention to heart disease prevention and promote research to develop better diagnostic treatment methods for the leading cause of death in most populations.

Forty years after this proclamation, the American Heart Association launched Go Red for Women. On the first Friday of American Heart Month, Americans are encouraged to wear red to draw attention to CVD as the leading cause of death among women as well as men.2,3 A 2024 report from the American Heart Institute and McKinsey Health Institute attributed at least one-third of the overall health care disparities between men and women to inequities in CVD care. These detrimental differences in the management of heart disease in women encompass both diagnostic misadventures and failure to promptly employ effective therapeutics. CVD morbidity and mortality data for Black women are even higher due to multiple and overlapping social determinants of health.4

Higher rates of hypertension, hyperlipidemia, and smoking in women veterans compared with civilians have resulted in an increased risk of heart disease and a 26% higher rate of CVD-related mortality. One in 10 women enrolled in US Department of Veterans Affairs (VA) health care has CVD. Research shows that these women are less likely compared to male veterans to receive counseling about exercise or to be prescribed medications such as statins, even when evidence-based treatment guidelines are followed. The increased rates of heart disease and its complications in women veterans are in part due to risk factors related to military service such as posttraumatic stress disorder (PTSD) and depression, which exceed the rates of nonveteran women.5

The heart has a long association with psychological health. For millennia, philosophers and physicians alike believed the heart was the center of the self and the locus of sentience. Even William Harvey, whose discovery of the circulation of blood earned him the title of the father of cardiology, viewed the heart as the life force.6 The heart has been explicitly linked to American military trauma since the Civil War era diagnosis of Soldier’s Heart. More recently, mutual genetic vulnerabilities to PTSD and CVD have been posited.7 Indeed, research with male combat veterans helped establish the association.

Until recently, there has been a dearth of research to establish the same connection between CVD and PTSD in women veterans, who have elevated rates of PTSD in part due to higher rates of homelessness and military sexual trauma.5 Due in large part to the work of a group of VA and US Department of Defense (DoD) researchers, this is starting to change. A research group conducted a retrospective longitudinal study using electronic health record data from nearly 400,000 women veterans to determine the propensity scores of associations between a PTSD diagnosis and the incidence of heart disease over nearly 5 years. The hazard ratio (HR) for the incidence of CVD in women with trauma was 1.44 (compared with matched controls) and even higher in younger women (HR, 1.72).8 Researchers also compared CVD mortality in civilian and veteran women and found a concerning trend: not only were mortality rates higher in veterans, but they also did not benefit from an overall improved trend in deaths from heart disease over the past 20 years.9

Two years later, the same VA/DoD research group conducted additional analysis on the dataset used in the prior study to examine potential mechanisms underlying the epidemiological link between CVD and PTSD in women veterans. Women with and without PTSD were matched on age and traditional CVD risk factor parameters. The findings demonstrated an association of PTSD with higher risks of diabetes, hypertension, hyperlipidemia, and smoking. However, these traditional risk factors only accounted for one-fourth of the total association. About 34% of the risk was attributed to depression, anxiety, and substance use disorders, as well as obesity and neuroendocrine disorders. This leaves slightly more than half of the elevated risk of CVD unexplained.10

This research, along with other studies, have identified several mechanisms elucidating the link. Promising translational research may lead to new diagnostic techniques or improved treatment modalities for CVD in women. The most established etiology is that veterans with PTSD have a higher prevalence of multiple CVD risk factors, including smoking, substance use disorders, obesity, poor diet, sleep disorders, depression, and inactivity. There is also increased recognition that PTSD involves neuroendocrine dysfunction in the stress-response that triggers a cascade of metabolic responses (eg, chronic inflammation) that contribute to the onset and progression of heart disease.11

This burgeoning scientific work on CVD and its close association with PTSD and the role of both traditional and nontraditional risk factors can inform VA efforts to educate frontline VA and DoD clinicians, leading to better care for women veterans. Whether a practitioner provides primary, specialty, or mental health care, this new knowledge can inform efforts to optimize prevention and treatment for both PTSD and CVD. For example, the VA/DoD researchers recommend prescribing antidepressants that are less likely to cause or worsen hypertension and to employ psychotherapies known to reduce the harmful CVD effects of increased stress acting through the hypothalamic-pituitary axis. These studies empower VA clinicians to realize Emily Dickinson’s aspiration to prevent trauma and reduce damage to both the psyche and the soma. The health of every veteran’s heart and mind matters, as does every effort of federal practitioners to protect and heal it.

References
  1. Dickinson E. The Complete Poems of Emily Dickinson. Back Bay Books; 1976.
  2. Centers for Disease Control. Heart disease facts. Updated October 24, 2024. Accessed January 27, 2025. https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html
  3. American Heart Association. Historical timeline of the American Heart Association. Accessed January 27, 2025. https:// www.heart.org/-/media/files/about-us/history/history-of-the-american-heart-association.pdf
  4. McKinsey Health Institute in Collaboration with the American Heart Association. The state of US women’s heart health: a path to improved health and financial outcomes. June 2024. Accessed January 27, 2025. https://www.goredforwomen.org/-/media/GRFW-Files/About-Heart-Disease-in-Women/The-state-of-US-womens-heart-health-report.pdf?sc_lang=en
  5. Han JK, Yano EM, Watson KE, Ebrahimi R. Cardiovascular Care in women veterans. Circulation. 2019;139(8):1102-1109. doi:10.1161/CIRCULATIONAHA.118.037748
  6. Conrad LI, Neve M, Nutton V, Porter R, Wear A. The Western Medical Tradition: 800 BC to AD 1800. Cambridge University Press; 1995:335-338.
  7. Bremner JD, Wittbrodt MT, Shah AJ, et al. Confederates in the attic: posttraumatic stress disorder, cardiovascular disease, and the return of soldier’s heart. J Nerv Ment Dis. 2020;208(3):171-180. doi:10.1097/NMD.0000000000001100
  8. Ebrahimi R, Lynch KE, Beckham JC, et al. Association of posttraumatic stress disorder and incident ischemic heart disease in women veterans. JAMA Cardiol. 2021;6(6):642-651. doi:10.1001/jamacardio.2021.0227
  9. Ebrahimi R, Yano EM, Alvarez CA, et al. Trends in cardiovascular disease mortality in US women veterans vs civilians. JAMA Netw Open. 2023;6(10):e2340242. doi:10.1001/jamanetworkopen.2023.40242
  10. Ebrahimi R, Dennis PA, Shroyer ALW, et al. Pathways linking post-traumatic stress disorder to incident ischemic heart disease in women: call to action. JACC Adv. 2023;3(1):100744. doi:10.1016/j.jacadv.2023.100744
  11. Arenson M, Cohen B. Posttraumatic Stress Disorder and Cardiovascular Disease. National Center for PTSD. PTSD Res Q. 2017;28(1):1-3. Accessed January 27, 2025. https://www.ptsd.va.gov/publications/rq_docs/V28N1.pdf
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If I can stop one heart from breaking, I shall not live in vain.
Emily Dickinson1

The celebration of Valentine’s Day has made the association of hearts with the month of February almost automatic. There is, though, another commemoration of hearts in the second month of the year with special significance for federal practice: American Heart Month. President Lyndon B. Johnson proclaimed February as American Heart Month in 1964 to raise awareness of the enormous human and economic cost of cardiovascular diseases (CVD) that impact many Americans in their prime.

The Centers for Disease Control and Prevention estimates that 1 in 5 deaths in the United States is due to CVD, which includes coronary artery disease, heart failure, heart attack, and stroke.2 American Heart Month aims to increase public attention to heart disease prevention and promote research to develop better diagnostic treatment methods for the leading cause of death in most populations.

Forty years after this proclamation, the American Heart Association launched Go Red for Women. On the first Friday of American Heart Month, Americans are encouraged to wear red to draw attention to CVD as the leading cause of death among women as well as men.2,3 A 2024 report from the American Heart Institute and McKinsey Health Institute attributed at least one-third of the overall health care disparities between men and women to inequities in CVD care. These detrimental differences in the management of heart disease in women encompass both diagnostic misadventures and failure to promptly employ effective therapeutics. CVD morbidity and mortality data for Black women are even higher due to multiple and overlapping social determinants of health.4

Higher rates of hypertension, hyperlipidemia, and smoking in women veterans compared with civilians have resulted in an increased risk of heart disease and a 26% higher rate of CVD-related mortality. One in 10 women enrolled in US Department of Veterans Affairs (VA) health care has CVD. Research shows that these women are less likely compared to male veterans to receive counseling about exercise or to be prescribed medications such as statins, even when evidence-based treatment guidelines are followed. The increased rates of heart disease and its complications in women veterans are in part due to risk factors related to military service such as posttraumatic stress disorder (PTSD) and depression, which exceed the rates of nonveteran women.5

The heart has a long association with psychological health. For millennia, philosophers and physicians alike believed the heart was the center of the self and the locus of sentience. Even William Harvey, whose discovery of the circulation of blood earned him the title of the father of cardiology, viewed the heart as the life force.6 The heart has been explicitly linked to American military trauma since the Civil War era diagnosis of Soldier’s Heart. More recently, mutual genetic vulnerabilities to PTSD and CVD have been posited.7 Indeed, research with male combat veterans helped establish the association.

Until recently, there has been a dearth of research to establish the same connection between CVD and PTSD in women veterans, who have elevated rates of PTSD in part due to higher rates of homelessness and military sexual trauma.5 Due in large part to the work of a group of VA and US Department of Defense (DoD) researchers, this is starting to change. A research group conducted a retrospective longitudinal study using electronic health record data from nearly 400,000 women veterans to determine the propensity scores of associations between a PTSD diagnosis and the incidence of heart disease over nearly 5 years. The hazard ratio (HR) for the incidence of CVD in women with trauma was 1.44 (compared with matched controls) and even higher in younger women (HR, 1.72).8 Researchers also compared CVD mortality in civilian and veteran women and found a concerning trend: not only were mortality rates higher in veterans, but they also did not benefit from an overall improved trend in deaths from heart disease over the past 20 years.9

Two years later, the same VA/DoD research group conducted additional analysis on the dataset used in the prior study to examine potential mechanisms underlying the epidemiological link between CVD and PTSD in women veterans. Women with and without PTSD were matched on age and traditional CVD risk factor parameters. The findings demonstrated an association of PTSD with higher risks of diabetes, hypertension, hyperlipidemia, and smoking. However, these traditional risk factors only accounted for one-fourth of the total association. About 34% of the risk was attributed to depression, anxiety, and substance use disorders, as well as obesity and neuroendocrine disorders. This leaves slightly more than half of the elevated risk of CVD unexplained.10

This research, along with other studies, have identified several mechanisms elucidating the link. Promising translational research may lead to new diagnostic techniques or improved treatment modalities for CVD in women. The most established etiology is that veterans with PTSD have a higher prevalence of multiple CVD risk factors, including smoking, substance use disorders, obesity, poor diet, sleep disorders, depression, and inactivity. There is also increased recognition that PTSD involves neuroendocrine dysfunction in the stress-response that triggers a cascade of metabolic responses (eg, chronic inflammation) that contribute to the onset and progression of heart disease.11

This burgeoning scientific work on CVD and its close association with PTSD and the role of both traditional and nontraditional risk factors can inform VA efforts to educate frontline VA and DoD clinicians, leading to better care for women veterans. Whether a practitioner provides primary, specialty, or mental health care, this new knowledge can inform efforts to optimize prevention and treatment for both PTSD and CVD. For example, the VA/DoD researchers recommend prescribing antidepressants that are less likely to cause or worsen hypertension and to employ psychotherapies known to reduce the harmful CVD effects of increased stress acting through the hypothalamic-pituitary axis. These studies empower VA clinicians to realize Emily Dickinson’s aspiration to prevent trauma and reduce damage to both the psyche and the soma. The health of every veteran’s heart and mind matters, as does every effort of federal practitioners to protect and heal it.

If I can stop one heart from breaking, I shall not live in vain.
Emily Dickinson1

The celebration of Valentine’s Day has made the association of hearts with the month of February almost automatic. There is, though, another commemoration of hearts in the second month of the year with special significance for federal practice: American Heart Month. President Lyndon B. Johnson proclaimed February as American Heart Month in 1964 to raise awareness of the enormous human and economic cost of cardiovascular diseases (CVD) that impact many Americans in their prime.

The Centers for Disease Control and Prevention estimates that 1 in 5 deaths in the United States is due to CVD, which includes coronary artery disease, heart failure, heart attack, and stroke.2 American Heart Month aims to increase public attention to heart disease prevention and promote research to develop better diagnostic treatment methods for the leading cause of death in most populations.

Forty years after this proclamation, the American Heart Association launched Go Red for Women. On the first Friday of American Heart Month, Americans are encouraged to wear red to draw attention to CVD as the leading cause of death among women as well as men.2,3 A 2024 report from the American Heart Institute and McKinsey Health Institute attributed at least one-third of the overall health care disparities between men and women to inequities in CVD care. These detrimental differences in the management of heart disease in women encompass both diagnostic misadventures and failure to promptly employ effective therapeutics. CVD morbidity and mortality data for Black women are even higher due to multiple and overlapping social determinants of health.4

Higher rates of hypertension, hyperlipidemia, and smoking in women veterans compared with civilians have resulted in an increased risk of heart disease and a 26% higher rate of CVD-related mortality. One in 10 women enrolled in US Department of Veterans Affairs (VA) health care has CVD. Research shows that these women are less likely compared to male veterans to receive counseling about exercise or to be prescribed medications such as statins, even when evidence-based treatment guidelines are followed. The increased rates of heart disease and its complications in women veterans are in part due to risk factors related to military service such as posttraumatic stress disorder (PTSD) and depression, which exceed the rates of nonveteran women.5

The heart has a long association with psychological health. For millennia, philosophers and physicians alike believed the heart was the center of the self and the locus of sentience. Even William Harvey, whose discovery of the circulation of blood earned him the title of the father of cardiology, viewed the heart as the life force.6 The heart has been explicitly linked to American military trauma since the Civil War era diagnosis of Soldier’s Heart. More recently, mutual genetic vulnerabilities to PTSD and CVD have been posited.7 Indeed, research with male combat veterans helped establish the association.

Until recently, there has been a dearth of research to establish the same connection between CVD and PTSD in women veterans, who have elevated rates of PTSD in part due to higher rates of homelessness and military sexual trauma.5 Due in large part to the work of a group of VA and US Department of Defense (DoD) researchers, this is starting to change. A research group conducted a retrospective longitudinal study using electronic health record data from nearly 400,000 women veterans to determine the propensity scores of associations between a PTSD diagnosis and the incidence of heart disease over nearly 5 years. The hazard ratio (HR) for the incidence of CVD in women with trauma was 1.44 (compared with matched controls) and even higher in younger women (HR, 1.72).8 Researchers also compared CVD mortality in civilian and veteran women and found a concerning trend: not only were mortality rates higher in veterans, but they also did not benefit from an overall improved trend in deaths from heart disease over the past 20 years.9

Two years later, the same VA/DoD research group conducted additional analysis on the dataset used in the prior study to examine potential mechanisms underlying the epidemiological link between CVD and PTSD in women veterans. Women with and without PTSD were matched on age and traditional CVD risk factor parameters. The findings demonstrated an association of PTSD with higher risks of diabetes, hypertension, hyperlipidemia, and smoking. However, these traditional risk factors only accounted for one-fourth of the total association. About 34% of the risk was attributed to depression, anxiety, and substance use disorders, as well as obesity and neuroendocrine disorders. This leaves slightly more than half of the elevated risk of CVD unexplained.10

This research, along with other studies, have identified several mechanisms elucidating the link. Promising translational research may lead to new diagnostic techniques or improved treatment modalities for CVD in women. The most established etiology is that veterans with PTSD have a higher prevalence of multiple CVD risk factors, including smoking, substance use disorders, obesity, poor diet, sleep disorders, depression, and inactivity. There is also increased recognition that PTSD involves neuroendocrine dysfunction in the stress-response that triggers a cascade of metabolic responses (eg, chronic inflammation) that contribute to the onset and progression of heart disease.11

This burgeoning scientific work on CVD and its close association with PTSD and the role of both traditional and nontraditional risk factors can inform VA efforts to educate frontline VA and DoD clinicians, leading to better care for women veterans. Whether a practitioner provides primary, specialty, or mental health care, this new knowledge can inform efforts to optimize prevention and treatment for both PTSD and CVD. For example, the VA/DoD researchers recommend prescribing antidepressants that are less likely to cause or worsen hypertension and to employ psychotherapies known to reduce the harmful CVD effects of increased stress acting through the hypothalamic-pituitary axis. These studies empower VA clinicians to realize Emily Dickinson’s aspiration to prevent trauma and reduce damage to both the psyche and the soma. The health of every veteran’s heart and mind matters, as does every effort of federal practitioners to protect and heal it.

References
  1. Dickinson E. The Complete Poems of Emily Dickinson. Back Bay Books; 1976.
  2. Centers for Disease Control. Heart disease facts. Updated October 24, 2024. Accessed January 27, 2025. https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html
  3. American Heart Association. Historical timeline of the American Heart Association. Accessed January 27, 2025. https:// www.heart.org/-/media/files/about-us/history/history-of-the-american-heart-association.pdf
  4. McKinsey Health Institute in Collaboration with the American Heart Association. The state of US women’s heart health: a path to improved health and financial outcomes. June 2024. Accessed January 27, 2025. https://www.goredforwomen.org/-/media/GRFW-Files/About-Heart-Disease-in-Women/The-state-of-US-womens-heart-health-report.pdf?sc_lang=en
  5. Han JK, Yano EM, Watson KE, Ebrahimi R. Cardiovascular Care in women veterans. Circulation. 2019;139(8):1102-1109. doi:10.1161/CIRCULATIONAHA.118.037748
  6. Conrad LI, Neve M, Nutton V, Porter R, Wear A. The Western Medical Tradition: 800 BC to AD 1800. Cambridge University Press; 1995:335-338.
  7. Bremner JD, Wittbrodt MT, Shah AJ, et al. Confederates in the attic: posttraumatic stress disorder, cardiovascular disease, and the return of soldier’s heart. J Nerv Ment Dis. 2020;208(3):171-180. doi:10.1097/NMD.0000000000001100
  8. Ebrahimi R, Lynch KE, Beckham JC, et al. Association of posttraumatic stress disorder and incident ischemic heart disease in women veterans. JAMA Cardiol. 2021;6(6):642-651. doi:10.1001/jamacardio.2021.0227
  9. Ebrahimi R, Yano EM, Alvarez CA, et al. Trends in cardiovascular disease mortality in US women veterans vs civilians. JAMA Netw Open. 2023;6(10):e2340242. doi:10.1001/jamanetworkopen.2023.40242
  10. Ebrahimi R, Dennis PA, Shroyer ALW, et al. Pathways linking post-traumatic stress disorder to incident ischemic heart disease in women: call to action. JACC Adv. 2023;3(1):100744. doi:10.1016/j.jacadv.2023.100744
  11. Arenson M, Cohen B. Posttraumatic Stress Disorder and Cardiovascular Disease. National Center for PTSD. PTSD Res Q. 2017;28(1):1-3. Accessed January 27, 2025. https://www.ptsd.va.gov/publications/rq_docs/V28N1.pdf
References
  1. Dickinson E. The Complete Poems of Emily Dickinson. Back Bay Books; 1976.
  2. Centers for Disease Control. Heart disease facts. Updated October 24, 2024. Accessed January 27, 2025. https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html
  3. American Heart Association. Historical timeline of the American Heart Association. Accessed January 27, 2025. https:// www.heart.org/-/media/files/about-us/history/history-of-the-american-heart-association.pdf
  4. McKinsey Health Institute in Collaboration with the American Heart Association. The state of US women’s heart health: a path to improved health and financial outcomes. June 2024. Accessed January 27, 2025. https://www.goredforwomen.org/-/media/GRFW-Files/About-Heart-Disease-in-Women/The-state-of-US-womens-heart-health-report.pdf?sc_lang=en
  5. Han JK, Yano EM, Watson KE, Ebrahimi R. Cardiovascular Care in women veterans. Circulation. 2019;139(8):1102-1109. doi:10.1161/CIRCULATIONAHA.118.037748
  6. Conrad LI, Neve M, Nutton V, Porter R, Wear A. The Western Medical Tradition: 800 BC to AD 1800. Cambridge University Press; 1995:335-338.
  7. Bremner JD, Wittbrodt MT, Shah AJ, et al. Confederates in the attic: posttraumatic stress disorder, cardiovascular disease, and the return of soldier’s heart. J Nerv Ment Dis. 2020;208(3):171-180. doi:10.1097/NMD.0000000000001100
  8. Ebrahimi R, Lynch KE, Beckham JC, et al. Association of posttraumatic stress disorder and incident ischemic heart disease in women veterans. JAMA Cardiol. 2021;6(6):642-651. doi:10.1001/jamacardio.2021.0227
  9. Ebrahimi R, Yano EM, Alvarez CA, et al. Trends in cardiovascular disease mortality in US women veterans vs civilians. JAMA Netw Open. 2023;6(10):e2340242. doi:10.1001/jamanetworkopen.2023.40242
  10. Ebrahimi R, Dennis PA, Shroyer ALW, et al. Pathways linking post-traumatic stress disorder to incident ischemic heart disease in women: call to action. JACC Adv. 2023;3(1):100744. doi:10.1016/j.jacadv.2023.100744
  11. Arenson M, Cohen B. Posttraumatic Stress Disorder and Cardiovascular Disease. National Center for PTSD. PTSD Res Q. 2017;28(1):1-3. Accessed January 27, 2025. https://www.ptsd.va.gov/publications/rq_docs/V28N1.pdf
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The Heart Matters: Women Veterans, Cardiovascular Disease, and PTSD

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The Year of AI: Learning With Machines to Improve Veteran Health Care

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The Year of AI: Learning With Machines to Improve Veteran Health Care

We have a tradition at Federal Practitioner where the December editorial usually features some version of the “best and worst” of the last 12 months in government health care. As we close out a difficult year, instead I offer a cautionary yet promising story that epitomizes both risk and benefit.

In some quarters, 2024 has been the year of AI (artificial intelligence).2 While in science fiction, superhuman machines, like the Terminator, are often associated with apocalyptic threats, we often forget the positive models of human-technology interaction, such as the protective robot in Lost in Space. While AI is not yet as advanced as what has already been depicted on the screen, it is inextricably interwoven into the daily fabric of our lives. Almost any website you go to for business or pleasure has a chatbot waiting to help (or frustrate) you. Most of us have Alexa, Siri, or another digital assistant organizing our homes and schedules. When I Google “everyday uses of artificial intelligence,” it is AI that responds with an overview.

Medicine is not immune. Renowned physician and scientist Eric Topol, MD, suggests that AI represents a “fourth industrial revolution in medicine” that can dramatically improve health care.3 The US Department of Veterans Affairs (VA) has been at the forefront of this new space.4 The story recounted below encapsulates the enormous benefits AI can bring to health care and the vigilance we must exercise to anticipate and mitigate risk for this to be an overall positive transition.

The story begins with a key element of AI change—the machine learning predictive algorithm. In this case, the algorithm was designed to predict—and thereby prevent—the top public health priority in federal practice: suicide. The Recovery Engagement and Coordination for Health-Veterans Enhanced Treatment (REACH VET) program was launched in 2017 to assist in identifying the top 0.1% of veterans at the highest risk for suicide.5

At least at this stage of AI in medicine, the safest and most ethical efforts come from collaborations between health care professionals and AI developers that maximize the very different strengths of each partner. REACH VET is an exemplar of this kind of teamwork. Once the algorithm analyzes > 60 variables to identify veterans at high risk for suicide, data are communicated to a REACH VET program coordinator, who then notifies the practitioner responsible for the veteran’s care so they can put into action evidence-based suicide prevention strategies.5

VA researchers in 2021 published a study of 173,313 veterans comparing outcomes before and after entry into the program using a triple differences design. Veterans participating in the program reported an increase in outpatient visits and documentation of safety plans, and a decrease in emergency department visits, inpatient mental health admissions, and recorded suicide attempts.6

A US Government Accounting Office analysis found that “REACH VET had identified veterans who had not been identified through other methods.”7 This was not just an example of AI hype: as a relatively rare and statistically complicated phenomenon, suicide is notoriously difficult to predict and model. Machine learning algorithms like REACH VET have unprecedented potential to assist and augment suicide prevention.8

In 2023, veteran service organizations and journalists raised concerns that the AI algorithm was biased and ignored critical risk factors that put some veterans at increased risk. Based on their analysis, they claimed that the algorithm did not account for risk factors uniquely associated with women veterans, namely military sexual trauma and intimate partner violence.9 Women are the most rapidly growing VA population, yet too often they encounter health care disparities, harassment, and stigmatization when seeking care. The Congressional Veterans Affairs committees investigated and introduced legislation to update the algorithm.10

VA experts dispute these claims, and a computer science PhD may be required to understand the debate. But as the history of medicine has shown us, every treatment and procedure has benefits and risks. No matter how bright and shiny the technology initially appears, a soft scientific underbelly emerges sooner or later. Just as with REACH VET, algorithm bias is often discovered during deployment when the logic of the laboratory encounters the unpredictable variety of humankind.11 Frequently, those problems are—as with REACH VET— not solely or even primarily technical ones. The data mirror society and reflect its biases.

For learning organizations like the VA and the US Department of Defense (DoD), the criticisms of REACH VET signal the need to engage in continuous performance improvement. AI requires the human trainers and supervisors who teach the machines to continuously revise and update their lesson plans. The most recent VA data show that in 2021, 6392 veterans died by suicide.12 In Congressional testimony, VA leaders reported that as of May 2024, REACH VET was operating in 28 VA facilities and had identified 6700 high-risk veterans.13 REACH VET can save veteran’s lives, which is the sine qua non for our federal health care systems.

The algorithm should be improved to identify ALL veterans so they receive lifesaving interventions. Every veteran’s life is sacred; the algorithm that may prevent suicide must be continuously improved. That is why our representatives did not propose to ban REACH VET or enforce an AI winter on the VA and DoD. Instead, they called for an update to the algorithm, underscoring the value of machine learning for suicide prediction and prevention.

The epigraph from one of the top AI ethicists and scientists in the world makes the point that AI is not the moral agent here: it is fallible humans who must keep learning along with machines. That is why, at the end of 2024, VA experts are revising the algorithm so REACH VET can help prevent even more veteran suicides in 2025 and beyond.14

References
  1. Waikar S. Health care’s AI future: a conversation with Fei Fei Li and Andrew Ng. HAI Stanford University. May 10, 2021. Accessed November 13, 2024. https://hai.stanford.edu/news/health-cares-ai-future-conversation-fei-fei-li-and-andrew-ng
  2. Johnson E, Forbes Technology Council. 2023 Was the Year of AI Hype—2024 is the Year of AI Practicality. Forbes. April 2, 2024. Accessed November 13, 2024. https://www.forbes.com/councils/forbestechcouncil/2024/04/02/2023-was-the-year-of-ai-hype-2024-is-the-year-of-ai-practicality/
  3. Topol E. Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again. Basic Books; 2019.
  4. Perlis R. The VA was an early adopter of artificial intelligence to improve care-here’s what they learned. JAMA. 2024;332(17):1411-1414. doi:10.1001/jama.2024.20563
  5. VA REACH VET initiative helps save lives [press release]. April 3, 2017. Accessed November 13, 2024. https://news.va.gov/36714/va-reach-vet-initiative-helps-save-veterans-lives/
  6. McCarthy JF, Cooper SA, Dent KR, et al. Evaluation of the recovery engagement and coordination for health-veterans enhanced treatment suicide risk modeling clinical program in the Veterans Health Administration. JAMA Netw Open. 2021;4(10):e2129900. doi:10.1001/jamanetworkopen.2021.29900
  7. US Government Office of Accountability. Veteran suicide: VA efforts to identify veterans at risk through analysis of health record information. September 14, 2022. Accessed November 13, 2024. https://www.gao.gov/products/gao-22-105165
  8. Pigoni A, Delvecchio G, Turtulici N, et al. Machine learning and the prediction of suicide in psychiatric populations: a systematic review. Transl Psychiatry. 2024;14(1):140. doi:10.1038/s41398-024-02852-9
  9. Glantz A. VA veteran suicide prevention algorithm favors men. Military.com. May 23, 2024. Accessed November 13, 2024. https://www.military.com/daily-news/2024/05/23/vas-veteran-suicide-prevention-algorithm-favors-men.html
  10. S.5210 BRAVE Act of 2024. 118th Congress. https://www.congress.gov/bill/118th-congress/senate-bill/5210/text
  11. Ratwani RM, Sutton K, and Galarrga JE. Addressing algorithmic bias in health care. JAMA. 2024;332(13):1051-1052. doi:10.1001/jama.2024.1348/
  12. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention. 2023 national veteran suicide prevention annual report. November 2023 Accessed November 13, 2024. https://www.mentalhealth.va.gov/docs/data-sheets/2023/2023-National-Veteran-Suicide-Prevention-Annual-Report-FINAL-508.pdf
  13. House Committee on Veterans Affairs. Health Chairwoman Miller-Meeks opens Iowa field hearing on breakthroughs in VA healthcare. May 13, 2024. Accessed November 13, 2024. https://veterans.house.gov/news/documentsingle.aspx?DocumentID=6452
  14. Graham E. VA is updating its AI suicide risk model to reach more women. NEXTGOV/FCW. October 18, 2024. Accessed November 13, 2024. https://www.nextgov.com/artificial-intelligence/2024/10/va-updating-its-ai-suicide-risk-model-reach-more-women/400377/
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We have a tradition at Federal Practitioner where the December editorial usually features some version of the “best and worst” of the last 12 months in government health care. As we close out a difficult year, instead I offer a cautionary yet promising story that epitomizes both risk and benefit.

In some quarters, 2024 has been the year of AI (artificial intelligence).2 While in science fiction, superhuman machines, like the Terminator, are often associated with apocalyptic threats, we often forget the positive models of human-technology interaction, such as the protective robot in Lost in Space. While AI is not yet as advanced as what has already been depicted on the screen, it is inextricably interwoven into the daily fabric of our lives. Almost any website you go to for business or pleasure has a chatbot waiting to help (or frustrate) you. Most of us have Alexa, Siri, or another digital assistant organizing our homes and schedules. When I Google “everyday uses of artificial intelligence,” it is AI that responds with an overview.

Medicine is not immune. Renowned physician and scientist Eric Topol, MD, suggests that AI represents a “fourth industrial revolution in medicine” that can dramatically improve health care.3 The US Department of Veterans Affairs (VA) has been at the forefront of this new space.4 The story recounted below encapsulates the enormous benefits AI can bring to health care and the vigilance we must exercise to anticipate and mitigate risk for this to be an overall positive transition.

The story begins with a key element of AI change—the machine learning predictive algorithm. In this case, the algorithm was designed to predict—and thereby prevent—the top public health priority in federal practice: suicide. The Recovery Engagement and Coordination for Health-Veterans Enhanced Treatment (REACH VET) program was launched in 2017 to assist in identifying the top 0.1% of veterans at the highest risk for suicide.5

At least at this stage of AI in medicine, the safest and most ethical efforts come from collaborations between health care professionals and AI developers that maximize the very different strengths of each partner. REACH VET is an exemplar of this kind of teamwork. Once the algorithm analyzes > 60 variables to identify veterans at high risk for suicide, data are communicated to a REACH VET program coordinator, who then notifies the practitioner responsible for the veteran’s care so they can put into action evidence-based suicide prevention strategies.5

VA researchers in 2021 published a study of 173,313 veterans comparing outcomes before and after entry into the program using a triple differences design. Veterans participating in the program reported an increase in outpatient visits and documentation of safety plans, and a decrease in emergency department visits, inpatient mental health admissions, and recorded suicide attempts.6

A US Government Accounting Office analysis found that “REACH VET had identified veterans who had not been identified through other methods.”7 This was not just an example of AI hype: as a relatively rare and statistically complicated phenomenon, suicide is notoriously difficult to predict and model. Machine learning algorithms like REACH VET have unprecedented potential to assist and augment suicide prevention.8

In 2023, veteran service organizations and journalists raised concerns that the AI algorithm was biased and ignored critical risk factors that put some veterans at increased risk. Based on their analysis, they claimed that the algorithm did not account for risk factors uniquely associated with women veterans, namely military sexual trauma and intimate partner violence.9 Women are the most rapidly growing VA population, yet too often they encounter health care disparities, harassment, and stigmatization when seeking care. The Congressional Veterans Affairs committees investigated and introduced legislation to update the algorithm.10

VA experts dispute these claims, and a computer science PhD may be required to understand the debate. But as the history of medicine has shown us, every treatment and procedure has benefits and risks. No matter how bright and shiny the technology initially appears, a soft scientific underbelly emerges sooner or later. Just as with REACH VET, algorithm bias is often discovered during deployment when the logic of the laboratory encounters the unpredictable variety of humankind.11 Frequently, those problems are—as with REACH VET— not solely or even primarily technical ones. The data mirror society and reflect its biases.

For learning organizations like the VA and the US Department of Defense (DoD), the criticisms of REACH VET signal the need to engage in continuous performance improvement. AI requires the human trainers and supervisors who teach the machines to continuously revise and update their lesson plans. The most recent VA data show that in 2021, 6392 veterans died by suicide.12 In Congressional testimony, VA leaders reported that as of May 2024, REACH VET was operating in 28 VA facilities and had identified 6700 high-risk veterans.13 REACH VET can save veteran’s lives, which is the sine qua non for our federal health care systems.

The algorithm should be improved to identify ALL veterans so they receive lifesaving interventions. Every veteran’s life is sacred; the algorithm that may prevent suicide must be continuously improved. That is why our representatives did not propose to ban REACH VET or enforce an AI winter on the VA and DoD. Instead, they called for an update to the algorithm, underscoring the value of machine learning for suicide prediction and prevention.

The epigraph from one of the top AI ethicists and scientists in the world makes the point that AI is not the moral agent here: it is fallible humans who must keep learning along with machines. That is why, at the end of 2024, VA experts are revising the algorithm so REACH VET can help prevent even more veteran suicides in 2025 and beyond.14

We have a tradition at Federal Practitioner where the December editorial usually features some version of the “best and worst” of the last 12 months in government health care. As we close out a difficult year, instead I offer a cautionary yet promising story that epitomizes both risk and benefit.

In some quarters, 2024 has been the year of AI (artificial intelligence).2 While in science fiction, superhuman machines, like the Terminator, are often associated with apocalyptic threats, we often forget the positive models of human-technology interaction, such as the protective robot in Lost in Space. While AI is not yet as advanced as what has already been depicted on the screen, it is inextricably interwoven into the daily fabric of our lives. Almost any website you go to for business or pleasure has a chatbot waiting to help (or frustrate) you. Most of us have Alexa, Siri, or another digital assistant organizing our homes and schedules. When I Google “everyday uses of artificial intelligence,” it is AI that responds with an overview.

Medicine is not immune. Renowned physician and scientist Eric Topol, MD, suggests that AI represents a “fourth industrial revolution in medicine” that can dramatically improve health care.3 The US Department of Veterans Affairs (VA) has been at the forefront of this new space.4 The story recounted below encapsulates the enormous benefits AI can bring to health care and the vigilance we must exercise to anticipate and mitigate risk for this to be an overall positive transition.

The story begins with a key element of AI change—the machine learning predictive algorithm. In this case, the algorithm was designed to predict—and thereby prevent—the top public health priority in federal practice: suicide. The Recovery Engagement and Coordination for Health-Veterans Enhanced Treatment (REACH VET) program was launched in 2017 to assist in identifying the top 0.1% of veterans at the highest risk for suicide.5

At least at this stage of AI in medicine, the safest and most ethical efforts come from collaborations between health care professionals and AI developers that maximize the very different strengths of each partner. REACH VET is an exemplar of this kind of teamwork. Once the algorithm analyzes > 60 variables to identify veterans at high risk for suicide, data are communicated to a REACH VET program coordinator, who then notifies the practitioner responsible for the veteran’s care so they can put into action evidence-based suicide prevention strategies.5

VA researchers in 2021 published a study of 173,313 veterans comparing outcomes before and after entry into the program using a triple differences design. Veterans participating in the program reported an increase in outpatient visits and documentation of safety plans, and a decrease in emergency department visits, inpatient mental health admissions, and recorded suicide attempts.6

A US Government Accounting Office analysis found that “REACH VET had identified veterans who had not been identified through other methods.”7 This was not just an example of AI hype: as a relatively rare and statistically complicated phenomenon, suicide is notoriously difficult to predict and model. Machine learning algorithms like REACH VET have unprecedented potential to assist and augment suicide prevention.8

In 2023, veteran service organizations and journalists raised concerns that the AI algorithm was biased and ignored critical risk factors that put some veterans at increased risk. Based on their analysis, they claimed that the algorithm did not account for risk factors uniquely associated with women veterans, namely military sexual trauma and intimate partner violence.9 Women are the most rapidly growing VA population, yet too often they encounter health care disparities, harassment, and stigmatization when seeking care. The Congressional Veterans Affairs committees investigated and introduced legislation to update the algorithm.10

VA experts dispute these claims, and a computer science PhD may be required to understand the debate. But as the history of medicine has shown us, every treatment and procedure has benefits and risks. No matter how bright and shiny the technology initially appears, a soft scientific underbelly emerges sooner or later. Just as with REACH VET, algorithm bias is often discovered during deployment when the logic of the laboratory encounters the unpredictable variety of humankind.11 Frequently, those problems are—as with REACH VET— not solely or even primarily technical ones. The data mirror society and reflect its biases.

For learning organizations like the VA and the US Department of Defense (DoD), the criticisms of REACH VET signal the need to engage in continuous performance improvement. AI requires the human trainers and supervisors who teach the machines to continuously revise and update their lesson plans. The most recent VA data show that in 2021, 6392 veterans died by suicide.12 In Congressional testimony, VA leaders reported that as of May 2024, REACH VET was operating in 28 VA facilities and had identified 6700 high-risk veterans.13 REACH VET can save veteran’s lives, which is the sine qua non for our federal health care systems.

The algorithm should be improved to identify ALL veterans so they receive lifesaving interventions. Every veteran’s life is sacred; the algorithm that may prevent suicide must be continuously improved. That is why our representatives did not propose to ban REACH VET or enforce an AI winter on the VA and DoD. Instead, they called for an update to the algorithm, underscoring the value of machine learning for suicide prediction and prevention.

The epigraph from one of the top AI ethicists and scientists in the world makes the point that AI is not the moral agent here: it is fallible humans who must keep learning along with machines. That is why, at the end of 2024, VA experts are revising the algorithm so REACH VET can help prevent even more veteran suicides in 2025 and beyond.14

References
  1. Waikar S. Health care’s AI future: a conversation with Fei Fei Li and Andrew Ng. HAI Stanford University. May 10, 2021. Accessed November 13, 2024. https://hai.stanford.edu/news/health-cares-ai-future-conversation-fei-fei-li-and-andrew-ng
  2. Johnson E, Forbes Technology Council. 2023 Was the Year of AI Hype—2024 is the Year of AI Practicality. Forbes. April 2, 2024. Accessed November 13, 2024. https://www.forbes.com/councils/forbestechcouncil/2024/04/02/2023-was-the-year-of-ai-hype-2024-is-the-year-of-ai-practicality/
  3. Topol E. Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again. Basic Books; 2019.
  4. Perlis R. The VA was an early adopter of artificial intelligence to improve care-here’s what they learned. JAMA. 2024;332(17):1411-1414. doi:10.1001/jama.2024.20563
  5. VA REACH VET initiative helps save lives [press release]. April 3, 2017. Accessed November 13, 2024. https://news.va.gov/36714/va-reach-vet-initiative-helps-save-veterans-lives/
  6. McCarthy JF, Cooper SA, Dent KR, et al. Evaluation of the recovery engagement and coordination for health-veterans enhanced treatment suicide risk modeling clinical program in the Veterans Health Administration. JAMA Netw Open. 2021;4(10):e2129900. doi:10.1001/jamanetworkopen.2021.29900
  7. US Government Office of Accountability. Veteran suicide: VA efforts to identify veterans at risk through analysis of health record information. September 14, 2022. Accessed November 13, 2024. https://www.gao.gov/products/gao-22-105165
  8. Pigoni A, Delvecchio G, Turtulici N, et al. Machine learning and the prediction of suicide in psychiatric populations: a systematic review. Transl Psychiatry. 2024;14(1):140. doi:10.1038/s41398-024-02852-9
  9. Glantz A. VA veteran suicide prevention algorithm favors men. Military.com. May 23, 2024. Accessed November 13, 2024. https://www.military.com/daily-news/2024/05/23/vas-veteran-suicide-prevention-algorithm-favors-men.html
  10. S.5210 BRAVE Act of 2024. 118th Congress. https://www.congress.gov/bill/118th-congress/senate-bill/5210/text
  11. Ratwani RM, Sutton K, and Galarrga JE. Addressing algorithmic bias in health care. JAMA. 2024;332(13):1051-1052. doi:10.1001/jama.2024.1348/
  12. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention. 2023 national veteran suicide prevention annual report. November 2023 Accessed November 13, 2024. https://www.mentalhealth.va.gov/docs/data-sheets/2023/2023-National-Veteran-Suicide-Prevention-Annual-Report-FINAL-508.pdf
  13. House Committee on Veterans Affairs. Health Chairwoman Miller-Meeks opens Iowa field hearing on breakthroughs in VA healthcare. May 13, 2024. Accessed November 13, 2024. https://veterans.house.gov/news/documentsingle.aspx?DocumentID=6452
  14. Graham E. VA is updating its AI suicide risk model to reach more women. NEXTGOV/FCW. October 18, 2024. Accessed November 13, 2024. https://www.nextgov.com/artificial-intelligence/2024/10/va-updating-its-ai-suicide-risk-model-reach-more-women/400377/
References
  1. Waikar S. Health care’s AI future: a conversation with Fei Fei Li and Andrew Ng. HAI Stanford University. May 10, 2021. Accessed November 13, 2024. https://hai.stanford.edu/news/health-cares-ai-future-conversation-fei-fei-li-and-andrew-ng
  2. Johnson E, Forbes Technology Council. 2023 Was the Year of AI Hype—2024 is the Year of AI Practicality. Forbes. April 2, 2024. Accessed November 13, 2024. https://www.forbes.com/councils/forbestechcouncil/2024/04/02/2023-was-the-year-of-ai-hype-2024-is-the-year-of-ai-practicality/
  3. Topol E. Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again. Basic Books; 2019.
  4. Perlis R. The VA was an early adopter of artificial intelligence to improve care-here’s what they learned. JAMA. 2024;332(17):1411-1414. doi:10.1001/jama.2024.20563
  5. VA REACH VET initiative helps save lives [press release]. April 3, 2017. Accessed November 13, 2024. https://news.va.gov/36714/va-reach-vet-initiative-helps-save-veterans-lives/
  6. McCarthy JF, Cooper SA, Dent KR, et al. Evaluation of the recovery engagement and coordination for health-veterans enhanced treatment suicide risk modeling clinical program in the Veterans Health Administration. JAMA Netw Open. 2021;4(10):e2129900. doi:10.1001/jamanetworkopen.2021.29900
  7. US Government Office of Accountability. Veteran suicide: VA efforts to identify veterans at risk through analysis of health record information. September 14, 2022. Accessed November 13, 2024. https://www.gao.gov/products/gao-22-105165
  8. Pigoni A, Delvecchio G, Turtulici N, et al. Machine learning and the prediction of suicide in psychiatric populations: a systematic review. Transl Psychiatry. 2024;14(1):140. doi:10.1038/s41398-024-02852-9
  9. Glantz A. VA veteran suicide prevention algorithm favors men. Military.com. May 23, 2024. Accessed November 13, 2024. https://www.military.com/daily-news/2024/05/23/vas-veteran-suicide-prevention-algorithm-favors-men.html
  10. S.5210 BRAVE Act of 2024. 118th Congress. https://www.congress.gov/bill/118th-congress/senate-bill/5210/text
  11. Ratwani RM, Sutton K, and Galarrga JE. Addressing algorithmic bias in health care. JAMA. 2024;332(13):1051-1052. doi:10.1001/jama.2024.1348/
  12. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention. 2023 national veteran suicide prevention annual report. November 2023 Accessed November 13, 2024. https://www.mentalhealth.va.gov/docs/data-sheets/2023/2023-National-Veteran-Suicide-Prevention-Annual-Report-FINAL-508.pdf
  13. House Committee on Veterans Affairs. Health Chairwoman Miller-Meeks opens Iowa field hearing on breakthroughs in VA healthcare. May 13, 2024. Accessed November 13, 2024. https://veterans.house.gov/news/documentsingle.aspx?DocumentID=6452
  14. Graham E. VA is updating its AI suicide risk model to reach more women. NEXTGOV/FCW. October 18, 2024. Accessed November 13, 2024. https://www.nextgov.com/artificial-intelligence/2024/10/va-updating-its-ai-suicide-risk-model-reach-more-women/400377/
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The Veteran’s Canon Under Fire

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As Veterans Day approaches, stores and restaurants will offer discounts and free meals to veterans. Children will write thank you letters, and citizens nationwide will raise flags to honor and thank veterans. We can never repay those who lost their life, health, or livelihood in defense of the nation. Since the American Revolution, and in gratitude for that incalculable debt, the US government, on behalf of the American public, has seen fit to grant a host of benefits and services to those who wore the uniform.2,3 Among the best known are health care, burial services, compensation and pensions, home loans, and the GI Bill.

Less recognized yet arguably essential for the fair and consistent provision of these entitlements is a legal principle: the veteran’s canon. A canon is a system of rules or maxims used to interpret legal instruments, such as statutes. They are not rules but serve as a “principle that guides the interpretation of the text.”4 Since I am not a lawyer, I will undoubtedly oversimplify this legal principle, but I hope to get enough right to explain why the veteran’s canon should matter to federal health care professionals.

At its core, the veteran’s canon means that when the US Department of Veterans Affairs (VA) and a veteran have a legal dispute about VA benefits, the courts will give deference to the veteran. Underscoring that any ambiguity in the statute is resolved in the veteran’s favor, the canon is known in legal circles as the Gardner deference. This is a reference to a 1994 case in which a Korean War veteran underwent surgery in a VA facility for a herniated disc he alleged caused pain and weakness in his left lower extremity.5 Gardner argued that federal statutes 38 USC § 1151 underlying corresponding VA regulation 38 CFR § 3.358(c)(3) granted disability benefits to veterans injured during VA treatment. The VA denied the disability claim, contending the regulation restricted compensation to veterans whose injury was the fault of the VA; thus, the disability had to have been the result of negligent treatment or an unforeseen therapeutic accident.5

The case wound its way through various appeals boards and courts until the Supreme Court of the United States (SCOTUS) ruled that the statute’s context left no ambiguity, and that any care provided under VA auspices was covered under the statute. What is important for this column is that the justices opined that had ambiguity been present, it would have legally necessitated, “applying the rule that interpretive doubt is to be resolved in the veteran’s favor.”5 In Gardner’s case, the courts reaffirmed nearly 80 years of judicial precedent upholding the veteran’s canon.

Thirty years later, Rudisill v McDonough again questioned the veteran’s canon.6 Educational benefits, namely the GI Bill, were the issue in this case. Rudisill served during 3 different periods in the US Army, totaling 8 years. Two educational programs overlapped during Rudisill’s tenure in the military: the Montgomery GI Bill and Post-9/11 Veterans Educational Assistance Act. Rudisill had used a portion of his Montgomery benefits to fund his undergraduate education and now wished to use the more extensive Post-9/11 assistance to finance his graduate degree. Rudisill and the VA disagreed about when his combined benefits would be capped, either at 36 or 48 months. After working its way through appeals courts, SCOTUS was again called upon for judgment.

The justices found that Rudisill qualified under both programs and could use them in any order he wished up to the cap. The majority found no ambiguity in the statute; however, if interpretation was required, the majority of justices indicated that the veteran’s canon would have supported Rudisill. While this sounds like good news for veterans, 2 justices authored a dissenting opinion that questioned the constitutional grounding of the veteran’s canon, noting that the “canon appears to have developed almost by accident.”6 The minority opinion suggested that when the veteran’s canon allocates resources to pay for specific veteran benefits, other interests and groups are deprived of those same resources, resulting in potential inequity.7

The potential ethical import and clinical impact of striking down the veteran’s canon is serious. It is especially concerning given that in a recent case, the SCOTUS ruling struck down another legal interpretation that also benefited the VA and ultimately veterans: the Chevron deference.8 This precedent held that when a legal dispute arises about the meaning of a specific federal agency regulation or policy, the courts should defer to the federal agency’s presumably superior understanding of the matter. The principle places the locus of decision-making with the subject-matter experts of the respective agency rather than the courts.

Ironically, given the legislative purposes of both interpretive principles, their overturning would likely introduce much more uncertainty, variation, and unpredictability in cases involving veteran benefits. This is bad news for both veterans and the VA. Veterans might not prevail as often in court when they have a reasonable claim, leading to more aggressive challenges. In response, the VA would have a heavier and more costly burden of administrative proof to defend sound decisions.9 Recently, the VA has tried to reduce the backlog of claims. The inability to have legal recourse to Chevron or Gardener could result in even more delay in adjudicating veterans’ claims that enable them to access benefits and services, already an object of congressional pressure.10

Courts will continue to debate the issue with another judicial test of the canon on the current SCOTUS docket (Bufkin v McDonough).11 The veteran’s canon was put in place to equalize the power differential between the VA and the veteran: in administrative language, to make it more likely than not that the veteran would prevail when regulations were ambiguous. There are many legal and political rationales for veteran’s canon, including enabling veterans to file claims for service-connected illnesses. The veteran’s cannon helped Vietnam War-era veterans receive VA care while researchers were still studying the sequela of Agent Orange exposure. 12 The legislative purpose of the veteran’s canon is the same as that of all VA benefits and services commemorated on Veterans Day. As expressed by SCOTUS justices in the wake of World War II, the benefit statutes should be “liberally construed for the benefit of those who left private life to serve their country in its hour of greatest need.”13

References
  1. Henderson v Shinseki, 562 US. 428, 440-441 (2011).
  2. US Department of Veterans Affairs, National Veteran Outreach Office. The difference between Veterans Day and Memorial Day. October 30, 2023. Accessed October 21, 2024. https://news.va.gov/125549/difference-between-veterans-day-memorial-day/
  3. US Department of Veterans Affairs. VA history summary. Updated August 6, 2024. Accessed October 21, 2024. https://department.va.gov/history/history-overview
  4. Cornell Law School, Legal Information Institute. Canons of construction. Updated March 2022. Accessed October 21, 2024. https://www.law.cornell.edu/wex/canons_of_construction
  5. Brown v Gardner, 513 US 115 (1994).
  6. Rudisill v McDonough, 601 US __ (2024).
  7. Hoover J. Justices will decide if vets are getting the ‘benefit of the doubt’. National Law Journal. April 30, 2024. Accessed October 21, 2024. https://www.law.com/nationallawjournal/2024/04/30/justices-will-decide-if-vets-are-getting-the-benefit-of-the-doubt/
  8. Relentless, Inc. v Department of Commerce Docket # 22-219, January 17, 2024.
  9. Kime P. Two veterans will argue to Supreme Court that VA disability claims aren’t getting, ‘benefit of the doubt’. Military. com. October 15, 2024. Accessed October 21, 2024. https:// www.military.com/daily-news/2024/10/15/supreme-court-hears-case-questioning-vas-commitment-favoring-veterans-benefits-decisions.html
  10. Rehagen J. SCOTUS’s chevron deference ruling: how it could hurt veterans and the VA. Veteran.com. Updated July 9, 2024. Accessed October 21, 2024. https://veteran.com/scotus-chevron-deference-impact-va-veteran/
  11. Hersey LF. Lawmakers urge VA to reduce backlog, wait times on veterans claims for benefits. Stars & Stripes. June 27, 2024. Accessed October 21, 2024. https://www.stripes.com/veterans/2024-06-27/veterans-benefits-claims-backlog-pact-act-14315042.html
  12. Harper CJ. Give veterans the benefit of the doubt: Chevron, Auer, and the veteran’s canon. Harvard J Law Public Policy. 2019; 42(3):931-969. https://journals.law.harvard.edu/jlpp/wp-content/uploads/sites/90/2019/06/42_3-Full-Issue.pdf
  13. Fishgold v Sullivan Drydock & Repair Corp, 328 US 275, 285 (1946).
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Fed Pract. 2024;41(11). Published online November 15. doi:10.12788/fp.0528

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Fed Pract. 2024;41(11). Published online November 15. doi:10.12788/fp.0528

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Fed Pract. 2024;41(11). Published online November 15. doi:10.12788/fp.0528

As Veterans Day approaches, stores and restaurants will offer discounts and free meals to veterans. Children will write thank you letters, and citizens nationwide will raise flags to honor and thank veterans. We can never repay those who lost their life, health, or livelihood in defense of the nation. Since the American Revolution, and in gratitude for that incalculable debt, the US government, on behalf of the American public, has seen fit to grant a host of benefits and services to those who wore the uniform.2,3 Among the best known are health care, burial services, compensation and pensions, home loans, and the GI Bill.

Less recognized yet arguably essential for the fair and consistent provision of these entitlements is a legal principle: the veteran’s canon. A canon is a system of rules or maxims used to interpret legal instruments, such as statutes. They are not rules but serve as a “principle that guides the interpretation of the text.”4 Since I am not a lawyer, I will undoubtedly oversimplify this legal principle, but I hope to get enough right to explain why the veteran’s canon should matter to federal health care professionals.

At its core, the veteran’s canon means that when the US Department of Veterans Affairs (VA) and a veteran have a legal dispute about VA benefits, the courts will give deference to the veteran. Underscoring that any ambiguity in the statute is resolved in the veteran’s favor, the canon is known in legal circles as the Gardner deference. This is a reference to a 1994 case in which a Korean War veteran underwent surgery in a VA facility for a herniated disc he alleged caused pain and weakness in his left lower extremity.5 Gardner argued that federal statutes 38 USC § 1151 underlying corresponding VA regulation 38 CFR § 3.358(c)(3) granted disability benefits to veterans injured during VA treatment. The VA denied the disability claim, contending the regulation restricted compensation to veterans whose injury was the fault of the VA; thus, the disability had to have been the result of negligent treatment or an unforeseen therapeutic accident.5

The case wound its way through various appeals boards and courts until the Supreme Court of the United States (SCOTUS) ruled that the statute’s context left no ambiguity, and that any care provided under VA auspices was covered under the statute. What is important for this column is that the justices opined that had ambiguity been present, it would have legally necessitated, “applying the rule that interpretive doubt is to be resolved in the veteran’s favor.”5 In Gardner’s case, the courts reaffirmed nearly 80 years of judicial precedent upholding the veteran’s canon.

Thirty years later, Rudisill v McDonough again questioned the veteran’s canon.6 Educational benefits, namely the GI Bill, were the issue in this case. Rudisill served during 3 different periods in the US Army, totaling 8 years. Two educational programs overlapped during Rudisill’s tenure in the military: the Montgomery GI Bill and Post-9/11 Veterans Educational Assistance Act. Rudisill had used a portion of his Montgomery benefits to fund his undergraduate education and now wished to use the more extensive Post-9/11 assistance to finance his graduate degree. Rudisill and the VA disagreed about when his combined benefits would be capped, either at 36 or 48 months. After working its way through appeals courts, SCOTUS was again called upon for judgment.

The justices found that Rudisill qualified under both programs and could use them in any order he wished up to the cap. The majority found no ambiguity in the statute; however, if interpretation was required, the majority of justices indicated that the veteran’s canon would have supported Rudisill. While this sounds like good news for veterans, 2 justices authored a dissenting opinion that questioned the constitutional grounding of the veteran’s canon, noting that the “canon appears to have developed almost by accident.”6 The minority opinion suggested that when the veteran’s canon allocates resources to pay for specific veteran benefits, other interests and groups are deprived of those same resources, resulting in potential inequity.7

The potential ethical import and clinical impact of striking down the veteran’s canon is serious. It is especially concerning given that in a recent case, the SCOTUS ruling struck down another legal interpretation that also benefited the VA and ultimately veterans: the Chevron deference.8 This precedent held that when a legal dispute arises about the meaning of a specific federal agency regulation or policy, the courts should defer to the federal agency’s presumably superior understanding of the matter. The principle places the locus of decision-making with the subject-matter experts of the respective agency rather than the courts.

Ironically, given the legislative purposes of both interpretive principles, their overturning would likely introduce much more uncertainty, variation, and unpredictability in cases involving veteran benefits. This is bad news for both veterans and the VA. Veterans might not prevail as often in court when they have a reasonable claim, leading to more aggressive challenges. In response, the VA would have a heavier and more costly burden of administrative proof to defend sound decisions.9 Recently, the VA has tried to reduce the backlog of claims. The inability to have legal recourse to Chevron or Gardener could result in even more delay in adjudicating veterans’ claims that enable them to access benefits and services, already an object of congressional pressure.10

Courts will continue to debate the issue with another judicial test of the canon on the current SCOTUS docket (Bufkin v McDonough).11 The veteran’s canon was put in place to equalize the power differential between the VA and the veteran: in administrative language, to make it more likely than not that the veteran would prevail when regulations were ambiguous. There are many legal and political rationales for veteran’s canon, including enabling veterans to file claims for service-connected illnesses. The veteran’s cannon helped Vietnam War-era veterans receive VA care while researchers were still studying the sequela of Agent Orange exposure. 12 The legislative purpose of the veteran’s canon is the same as that of all VA benefits and services commemorated on Veterans Day. As expressed by SCOTUS justices in the wake of World War II, the benefit statutes should be “liberally construed for the benefit of those who left private life to serve their country in its hour of greatest need.”13

As Veterans Day approaches, stores and restaurants will offer discounts and free meals to veterans. Children will write thank you letters, and citizens nationwide will raise flags to honor and thank veterans. We can never repay those who lost their life, health, or livelihood in defense of the nation. Since the American Revolution, and in gratitude for that incalculable debt, the US government, on behalf of the American public, has seen fit to grant a host of benefits and services to those who wore the uniform.2,3 Among the best known are health care, burial services, compensation and pensions, home loans, and the GI Bill.

Less recognized yet arguably essential for the fair and consistent provision of these entitlements is a legal principle: the veteran’s canon. A canon is a system of rules or maxims used to interpret legal instruments, such as statutes. They are not rules but serve as a “principle that guides the interpretation of the text.”4 Since I am not a lawyer, I will undoubtedly oversimplify this legal principle, but I hope to get enough right to explain why the veteran’s canon should matter to federal health care professionals.

At its core, the veteran’s canon means that when the US Department of Veterans Affairs (VA) and a veteran have a legal dispute about VA benefits, the courts will give deference to the veteran. Underscoring that any ambiguity in the statute is resolved in the veteran’s favor, the canon is known in legal circles as the Gardner deference. This is a reference to a 1994 case in which a Korean War veteran underwent surgery in a VA facility for a herniated disc he alleged caused pain and weakness in his left lower extremity.5 Gardner argued that federal statutes 38 USC § 1151 underlying corresponding VA regulation 38 CFR § 3.358(c)(3) granted disability benefits to veterans injured during VA treatment. The VA denied the disability claim, contending the regulation restricted compensation to veterans whose injury was the fault of the VA; thus, the disability had to have been the result of negligent treatment or an unforeseen therapeutic accident.5

The case wound its way through various appeals boards and courts until the Supreme Court of the United States (SCOTUS) ruled that the statute’s context left no ambiguity, and that any care provided under VA auspices was covered under the statute. What is important for this column is that the justices opined that had ambiguity been present, it would have legally necessitated, “applying the rule that interpretive doubt is to be resolved in the veteran’s favor.”5 In Gardner’s case, the courts reaffirmed nearly 80 years of judicial precedent upholding the veteran’s canon.

Thirty years later, Rudisill v McDonough again questioned the veteran’s canon.6 Educational benefits, namely the GI Bill, were the issue in this case. Rudisill served during 3 different periods in the US Army, totaling 8 years. Two educational programs overlapped during Rudisill’s tenure in the military: the Montgomery GI Bill and Post-9/11 Veterans Educational Assistance Act. Rudisill had used a portion of his Montgomery benefits to fund his undergraduate education and now wished to use the more extensive Post-9/11 assistance to finance his graduate degree. Rudisill and the VA disagreed about when his combined benefits would be capped, either at 36 or 48 months. After working its way through appeals courts, SCOTUS was again called upon for judgment.

The justices found that Rudisill qualified under both programs and could use them in any order he wished up to the cap. The majority found no ambiguity in the statute; however, if interpretation was required, the majority of justices indicated that the veteran’s canon would have supported Rudisill. While this sounds like good news for veterans, 2 justices authored a dissenting opinion that questioned the constitutional grounding of the veteran’s canon, noting that the “canon appears to have developed almost by accident.”6 The minority opinion suggested that when the veteran’s canon allocates resources to pay for specific veteran benefits, other interests and groups are deprived of those same resources, resulting in potential inequity.7

The potential ethical import and clinical impact of striking down the veteran’s canon is serious. It is especially concerning given that in a recent case, the SCOTUS ruling struck down another legal interpretation that also benefited the VA and ultimately veterans: the Chevron deference.8 This precedent held that when a legal dispute arises about the meaning of a specific federal agency regulation or policy, the courts should defer to the federal agency’s presumably superior understanding of the matter. The principle places the locus of decision-making with the subject-matter experts of the respective agency rather than the courts.

Ironically, given the legislative purposes of both interpretive principles, their overturning would likely introduce much more uncertainty, variation, and unpredictability in cases involving veteran benefits. This is bad news for both veterans and the VA. Veterans might not prevail as often in court when they have a reasonable claim, leading to more aggressive challenges. In response, the VA would have a heavier and more costly burden of administrative proof to defend sound decisions.9 Recently, the VA has tried to reduce the backlog of claims. The inability to have legal recourse to Chevron or Gardener could result in even more delay in adjudicating veterans’ claims that enable them to access benefits and services, already an object of congressional pressure.10

Courts will continue to debate the issue with another judicial test of the canon on the current SCOTUS docket (Bufkin v McDonough).11 The veteran’s canon was put in place to equalize the power differential between the VA and the veteran: in administrative language, to make it more likely than not that the veteran would prevail when regulations were ambiguous. There are many legal and political rationales for veteran’s canon, including enabling veterans to file claims for service-connected illnesses. The veteran’s cannon helped Vietnam War-era veterans receive VA care while researchers were still studying the sequela of Agent Orange exposure. 12 The legislative purpose of the veteran’s canon is the same as that of all VA benefits and services commemorated on Veterans Day. As expressed by SCOTUS justices in the wake of World War II, the benefit statutes should be “liberally construed for the benefit of those who left private life to serve their country in its hour of greatest need.”13

References
  1. Henderson v Shinseki, 562 US. 428, 440-441 (2011).
  2. US Department of Veterans Affairs, National Veteran Outreach Office. The difference between Veterans Day and Memorial Day. October 30, 2023. Accessed October 21, 2024. https://news.va.gov/125549/difference-between-veterans-day-memorial-day/
  3. US Department of Veterans Affairs. VA history summary. Updated August 6, 2024. Accessed October 21, 2024. https://department.va.gov/history/history-overview
  4. Cornell Law School, Legal Information Institute. Canons of construction. Updated March 2022. Accessed October 21, 2024. https://www.law.cornell.edu/wex/canons_of_construction
  5. Brown v Gardner, 513 US 115 (1994).
  6. Rudisill v McDonough, 601 US __ (2024).
  7. Hoover J. Justices will decide if vets are getting the ‘benefit of the doubt’. National Law Journal. April 30, 2024. Accessed October 21, 2024. https://www.law.com/nationallawjournal/2024/04/30/justices-will-decide-if-vets-are-getting-the-benefit-of-the-doubt/
  8. Relentless, Inc. v Department of Commerce Docket # 22-219, January 17, 2024.
  9. Kime P. Two veterans will argue to Supreme Court that VA disability claims aren’t getting, ‘benefit of the doubt’. Military. com. October 15, 2024. Accessed October 21, 2024. https:// www.military.com/daily-news/2024/10/15/supreme-court-hears-case-questioning-vas-commitment-favoring-veterans-benefits-decisions.html
  10. Rehagen J. SCOTUS’s chevron deference ruling: how it could hurt veterans and the VA. Veteran.com. Updated July 9, 2024. Accessed October 21, 2024. https://veteran.com/scotus-chevron-deference-impact-va-veteran/
  11. Hersey LF. Lawmakers urge VA to reduce backlog, wait times on veterans claims for benefits. Stars & Stripes. June 27, 2024. Accessed October 21, 2024. https://www.stripes.com/veterans/2024-06-27/veterans-benefits-claims-backlog-pact-act-14315042.html
  12. Harper CJ. Give veterans the benefit of the doubt: Chevron, Auer, and the veteran’s canon. Harvard J Law Public Policy. 2019; 42(3):931-969. https://journals.law.harvard.edu/jlpp/wp-content/uploads/sites/90/2019/06/42_3-Full-Issue.pdf
  13. Fishgold v Sullivan Drydock & Repair Corp, 328 US 275, 285 (1946).
References
  1. Henderson v Shinseki, 562 US. 428, 440-441 (2011).
  2. US Department of Veterans Affairs, National Veteran Outreach Office. The difference between Veterans Day and Memorial Day. October 30, 2023. Accessed October 21, 2024. https://news.va.gov/125549/difference-between-veterans-day-memorial-day/
  3. US Department of Veterans Affairs. VA history summary. Updated August 6, 2024. Accessed October 21, 2024. https://department.va.gov/history/history-overview
  4. Cornell Law School, Legal Information Institute. Canons of construction. Updated March 2022. Accessed October 21, 2024. https://www.law.cornell.edu/wex/canons_of_construction
  5. Brown v Gardner, 513 US 115 (1994).
  6. Rudisill v McDonough, 601 US __ (2024).
  7. Hoover J. Justices will decide if vets are getting the ‘benefit of the doubt’. National Law Journal. April 30, 2024. Accessed October 21, 2024. https://www.law.com/nationallawjournal/2024/04/30/justices-will-decide-if-vets-are-getting-the-benefit-of-the-doubt/
  8. Relentless, Inc. v Department of Commerce Docket # 22-219, January 17, 2024.
  9. Kime P. Two veterans will argue to Supreme Court that VA disability claims aren’t getting, ‘benefit of the doubt’. Military. com. October 15, 2024. Accessed October 21, 2024. https:// www.military.com/daily-news/2024/10/15/supreme-court-hears-case-questioning-vas-commitment-favoring-veterans-benefits-decisions.html
  10. Rehagen J. SCOTUS’s chevron deference ruling: how it could hurt veterans and the VA. Veteran.com. Updated July 9, 2024. Accessed October 21, 2024. https://veteran.com/scotus-chevron-deference-impact-va-veteran/
  11. Hersey LF. Lawmakers urge VA to reduce backlog, wait times on veterans claims for benefits. Stars & Stripes. June 27, 2024. Accessed October 21, 2024. https://www.stripes.com/veterans/2024-06-27/veterans-benefits-claims-backlog-pact-act-14315042.html
  12. Harper CJ. Give veterans the benefit of the doubt: Chevron, Auer, and the veteran’s canon. Harvard J Law Public Policy. 2019; 42(3):931-969. https://journals.law.harvard.edu/jlpp/wp-content/uploads/sites/90/2019/06/42_3-Full-Issue.pdf
  13. Fishgold v Sullivan Drydock & Repair Corp, 328 US 275, 285 (1946).
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Quality Improvement in Health Care: From Conceptual Frameworks and Definitions to Implementation

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As the movement to improve quality in health care has evolved over the past several decades, organizations whose missions focus on supporting and promoting quality in health care have defined essential concepts, standards, and measures that comprise quality and that can be used to guide quality improvement (QI) work. The World Health Organization (WHO) defines quality in clinical care as safe, effective, and people-centered service.1 These 3 pillars of quality form the foundation of a quality system aiming to deliver health care in a timely, equitable, efficient, and integrated manner. The WHO estimates that 5.7 to 8.4 million deaths occur yearly in low- and middle-income countries due to poor quality care. Regarding safety, patient harm from unsafe care is estimated to be among the top 10 causes of death and disability worldwide.2 A health care QI plan involves identifying areas for improvement, setting measurable goals, implementing evidence-based strategies and interventions, monitoring progress toward achieving those goals, and continuously evaluating and adjusting the plan as needed to ensure sustained improvement over time. Such a plan can be implemented at various levels of health care organizations, from individual clinical units to entire hospitals or even regional health care systems.

The Institute of Medicine (IOM) identifies 5 domains of quality in health care: effectiveness, efficiency, equity, patient-centeredness, and safety.3 Effectiveness relies on providing care processes supported by scientific evidence and achieving desired outcomes in the IOM recommendations. The primary efficiency aim maximizes the quality of health care delivered or the benefits achieved for a given resource unit. Equity relates to providing health care of equal quality to all individuals, regardless of personal characteristics. Moreover, patient-centeredness relates to meeting patients’ needs and preferences and providing education and support. Safety relates to avoiding actual or potential harm. Timeliness relates to obtaining needed care while minimizing delays. Finally, the IOM defines health care quality as the systematic evaluation and provision of evidence-based and safe care characterized by a culture of continuous improvement, resulting in optimal health outcomes. Taking all these concepts into consideration, 4 key attributes have been identified as essential to the global definition of health care quality: effectiveness, safety, culture of continuous improvement, and desired outcomes. This conceptualization of health care quality encompasses the fundamental components and has the potential to enhance the delivery of care. This definition’s theoretical and practical implications provide a comprehensive and consistent understanding of the elements required to improve health care and maintain public trust.

Health care quality is a dynamic, ever-evolving construct that requires continuous assessment and evaluation to ensure the delivery of care meets the changing needs of society. The National Quality Forum’s National Voluntary Consensus Standards for health care provide measures, guidance, and recommendations on achieving effective outcomes through evidence-based practices.4 These standards establish criteria by which health care systems and providers can assess and improve their quality performance.

In the United States, in order to implement and disseminate best practices, the Centers for Medicare & Medicaid Services (CMS) developed Quality Payment Programs that offer incentives to health care providers to improve the quality of care delivery. This CMS program evaluates providers based on their performance in the Merit-Based Incentive Payment System performance categories.5 These include measures related to patient experience, cost, clinical quality, improvement activities, and the use of certified electronic health record technology. The scores that providers receive are used to determine their performance-based reimbursements under Medicare’s fee-for-service program.

The concept of health care quality is also applicable in other countries. In the United Kingdom, QI initiatives are led by the Department of Health and Social Care. The National Institute for Health and Care Excellence (NICE) produces guidelines on best practices to ensure that care delivery meets established safety and quality standards, reaching cost-effectiveness excellence.6 In Australia, the Australian Commission on Quality and Safety in Health Care is responsible for setting benchmarks for performance in health care systems through a clear, structured agenda.7 Ultimately, health care quality is a complex and multifaceted issue that requires a comprehensive approach to ensure the best outcomes for patients. With the implementation of measures such as the CMS Quality Payment Programs and NICE guidelines, health care organizations can take steps to ensure their systems of care delivery reflect evidence-based practices and demonstrate a commitment to providing high-quality care.

Implementing a health care QI plan that encompasses the 4 key attributes of health care quality—effectiveness, safety, culture of continuous improvement, and desired outcomes—requires collaboration among different departments and stakeholders and a data-driven approach to decision-making. Effective communication with patients and their families is critical to ensuring that their needs are being met and that they are active partners in their health care journey. While a health care QI plan is essential for delivering high-quality, safe patient care, it also helps health care organizations comply with regulatory requirements, meet accreditation standards, and stay competitive in the ever-evolving health care landscape.

Corresponding author: Ebrahim Barkoudah, MD, MPH; Ebrahim.Barkoudah@baystatehealth.org

References

1. World Health Organization. Quality of care. Accessed on May 17, 2023. www.who.int/health-topics/quality-of-care#tab=tab_1

2. World Health Organization. Patient safety. Accessed on May 17, 2023 www.who.int/news-room/fact-sheets/detail/patient-safety

3. Agency for Healthcare Research and Quality. Understanding quality measurement. Accessed on May 17, 2023. www.ahrq.gov/patient-safety/quality-resources/tools/chtoolbx/understand/index.html

4. Ferrell B, Connor SR, Cordes A, et al. The national agenda for quality palliative care: the National Consensus Project and the National Quality Forum. J Pain Symptom Manage. 2007;33(6):737-744. doi:10.1016/j.jpainsymman.2007.02.024

5. U.S Centers for Medicare & Medicaid Services. Quality payment program. Accessed on March 14, 2023 qpp.cms.gov/mips/overview

6. Claxton K, Martin S, Soares M, et al. Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold. Health Technol Assess. 2015;19(14):1-503, v-vi. doi: 10.3310/hta19140

7. Braithwaite J, Healy J, Dwan K. The Governance of Health Safety and Quality, Commonwealth of Australia. Accessed May 17, 2023. https://regnet.anu.edu.au/research/publications/3626/governance-health-safety-and-quality 2005

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As the movement to improve quality in health care has evolved over the past several decades, organizations whose missions focus on supporting and promoting quality in health care have defined essential concepts, standards, and measures that comprise quality and that can be used to guide quality improvement (QI) work. The World Health Organization (WHO) defines quality in clinical care as safe, effective, and people-centered service.1 These 3 pillars of quality form the foundation of a quality system aiming to deliver health care in a timely, equitable, efficient, and integrated manner. The WHO estimates that 5.7 to 8.4 million deaths occur yearly in low- and middle-income countries due to poor quality care. Regarding safety, patient harm from unsafe care is estimated to be among the top 10 causes of death and disability worldwide.2 A health care QI plan involves identifying areas for improvement, setting measurable goals, implementing evidence-based strategies and interventions, monitoring progress toward achieving those goals, and continuously evaluating and adjusting the plan as needed to ensure sustained improvement over time. Such a plan can be implemented at various levels of health care organizations, from individual clinical units to entire hospitals or even regional health care systems.

The Institute of Medicine (IOM) identifies 5 domains of quality in health care: effectiveness, efficiency, equity, patient-centeredness, and safety.3 Effectiveness relies on providing care processes supported by scientific evidence and achieving desired outcomes in the IOM recommendations. The primary efficiency aim maximizes the quality of health care delivered or the benefits achieved for a given resource unit. Equity relates to providing health care of equal quality to all individuals, regardless of personal characteristics. Moreover, patient-centeredness relates to meeting patients’ needs and preferences and providing education and support. Safety relates to avoiding actual or potential harm. Timeliness relates to obtaining needed care while minimizing delays. Finally, the IOM defines health care quality as the systematic evaluation and provision of evidence-based and safe care characterized by a culture of continuous improvement, resulting in optimal health outcomes. Taking all these concepts into consideration, 4 key attributes have been identified as essential to the global definition of health care quality: effectiveness, safety, culture of continuous improvement, and desired outcomes. This conceptualization of health care quality encompasses the fundamental components and has the potential to enhance the delivery of care. This definition’s theoretical and practical implications provide a comprehensive and consistent understanding of the elements required to improve health care and maintain public trust.

Health care quality is a dynamic, ever-evolving construct that requires continuous assessment and evaluation to ensure the delivery of care meets the changing needs of society. The National Quality Forum’s National Voluntary Consensus Standards for health care provide measures, guidance, and recommendations on achieving effective outcomes through evidence-based practices.4 These standards establish criteria by which health care systems and providers can assess and improve their quality performance.

In the United States, in order to implement and disseminate best practices, the Centers for Medicare & Medicaid Services (CMS) developed Quality Payment Programs that offer incentives to health care providers to improve the quality of care delivery. This CMS program evaluates providers based on their performance in the Merit-Based Incentive Payment System performance categories.5 These include measures related to patient experience, cost, clinical quality, improvement activities, and the use of certified electronic health record technology. The scores that providers receive are used to determine their performance-based reimbursements under Medicare’s fee-for-service program.

The concept of health care quality is also applicable in other countries. In the United Kingdom, QI initiatives are led by the Department of Health and Social Care. The National Institute for Health and Care Excellence (NICE) produces guidelines on best practices to ensure that care delivery meets established safety and quality standards, reaching cost-effectiveness excellence.6 In Australia, the Australian Commission on Quality and Safety in Health Care is responsible for setting benchmarks for performance in health care systems through a clear, structured agenda.7 Ultimately, health care quality is a complex and multifaceted issue that requires a comprehensive approach to ensure the best outcomes for patients. With the implementation of measures such as the CMS Quality Payment Programs and NICE guidelines, health care organizations can take steps to ensure their systems of care delivery reflect evidence-based practices and demonstrate a commitment to providing high-quality care.

Implementing a health care QI plan that encompasses the 4 key attributes of health care quality—effectiveness, safety, culture of continuous improvement, and desired outcomes—requires collaboration among different departments and stakeholders and a data-driven approach to decision-making. Effective communication with patients and their families is critical to ensuring that their needs are being met and that they are active partners in their health care journey. While a health care QI plan is essential for delivering high-quality, safe patient care, it also helps health care organizations comply with regulatory requirements, meet accreditation standards, and stay competitive in the ever-evolving health care landscape.

Corresponding author: Ebrahim Barkoudah, MD, MPH; Ebrahim.Barkoudah@baystatehealth.org

As the movement to improve quality in health care has evolved over the past several decades, organizations whose missions focus on supporting and promoting quality in health care have defined essential concepts, standards, and measures that comprise quality and that can be used to guide quality improvement (QI) work. The World Health Organization (WHO) defines quality in clinical care as safe, effective, and people-centered service.1 These 3 pillars of quality form the foundation of a quality system aiming to deliver health care in a timely, equitable, efficient, and integrated manner. The WHO estimates that 5.7 to 8.4 million deaths occur yearly in low- and middle-income countries due to poor quality care. Regarding safety, patient harm from unsafe care is estimated to be among the top 10 causes of death and disability worldwide.2 A health care QI plan involves identifying areas for improvement, setting measurable goals, implementing evidence-based strategies and interventions, monitoring progress toward achieving those goals, and continuously evaluating and adjusting the plan as needed to ensure sustained improvement over time. Such a plan can be implemented at various levels of health care organizations, from individual clinical units to entire hospitals or even regional health care systems.

The Institute of Medicine (IOM) identifies 5 domains of quality in health care: effectiveness, efficiency, equity, patient-centeredness, and safety.3 Effectiveness relies on providing care processes supported by scientific evidence and achieving desired outcomes in the IOM recommendations. The primary efficiency aim maximizes the quality of health care delivered or the benefits achieved for a given resource unit. Equity relates to providing health care of equal quality to all individuals, regardless of personal characteristics. Moreover, patient-centeredness relates to meeting patients’ needs and preferences and providing education and support. Safety relates to avoiding actual or potential harm. Timeliness relates to obtaining needed care while minimizing delays. Finally, the IOM defines health care quality as the systematic evaluation and provision of evidence-based and safe care characterized by a culture of continuous improvement, resulting in optimal health outcomes. Taking all these concepts into consideration, 4 key attributes have been identified as essential to the global definition of health care quality: effectiveness, safety, culture of continuous improvement, and desired outcomes. This conceptualization of health care quality encompasses the fundamental components and has the potential to enhance the delivery of care. This definition’s theoretical and practical implications provide a comprehensive and consistent understanding of the elements required to improve health care and maintain public trust.

Health care quality is a dynamic, ever-evolving construct that requires continuous assessment and evaluation to ensure the delivery of care meets the changing needs of society. The National Quality Forum’s National Voluntary Consensus Standards for health care provide measures, guidance, and recommendations on achieving effective outcomes through evidence-based practices.4 These standards establish criteria by which health care systems and providers can assess and improve their quality performance.

In the United States, in order to implement and disseminate best practices, the Centers for Medicare & Medicaid Services (CMS) developed Quality Payment Programs that offer incentives to health care providers to improve the quality of care delivery. This CMS program evaluates providers based on their performance in the Merit-Based Incentive Payment System performance categories.5 These include measures related to patient experience, cost, clinical quality, improvement activities, and the use of certified electronic health record technology. The scores that providers receive are used to determine their performance-based reimbursements under Medicare’s fee-for-service program.

The concept of health care quality is also applicable in other countries. In the United Kingdom, QI initiatives are led by the Department of Health and Social Care. The National Institute for Health and Care Excellence (NICE) produces guidelines on best practices to ensure that care delivery meets established safety and quality standards, reaching cost-effectiveness excellence.6 In Australia, the Australian Commission on Quality and Safety in Health Care is responsible for setting benchmarks for performance in health care systems through a clear, structured agenda.7 Ultimately, health care quality is a complex and multifaceted issue that requires a comprehensive approach to ensure the best outcomes for patients. With the implementation of measures such as the CMS Quality Payment Programs and NICE guidelines, health care organizations can take steps to ensure their systems of care delivery reflect evidence-based practices and demonstrate a commitment to providing high-quality care.

Implementing a health care QI plan that encompasses the 4 key attributes of health care quality—effectiveness, safety, culture of continuous improvement, and desired outcomes—requires collaboration among different departments and stakeholders and a data-driven approach to decision-making. Effective communication with patients and their families is critical to ensuring that their needs are being met and that they are active partners in their health care journey. While a health care QI plan is essential for delivering high-quality, safe patient care, it also helps health care organizations comply with regulatory requirements, meet accreditation standards, and stay competitive in the ever-evolving health care landscape.

Corresponding author: Ebrahim Barkoudah, MD, MPH; Ebrahim.Barkoudah@baystatehealth.org

References

1. World Health Organization. Quality of care. Accessed on May 17, 2023. www.who.int/health-topics/quality-of-care#tab=tab_1

2. World Health Organization. Patient safety. Accessed on May 17, 2023 www.who.int/news-room/fact-sheets/detail/patient-safety

3. Agency for Healthcare Research and Quality. Understanding quality measurement. Accessed on May 17, 2023. www.ahrq.gov/patient-safety/quality-resources/tools/chtoolbx/understand/index.html

4. Ferrell B, Connor SR, Cordes A, et al. The national agenda for quality palliative care: the National Consensus Project and the National Quality Forum. J Pain Symptom Manage. 2007;33(6):737-744. doi:10.1016/j.jpainsymman.2007.02.024

5. U.S Centers for Medicare & Medicaid Services. Quality payment program. Accessed on March 14, 2023 qpp.cms.gov/mips/overview

6. Claxton K, Martin S, Soares M, et al. Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold. Health Technol Assess. 2015;19(14):1-503, v-vi. doi: 10.3310/hta19140

7. Braithwaite J, Healy J, Dwan K. The Governance of Health Safety and Quality, Commonwealth of Australia. Accessed May 17, 2023. https://regnet.anu.edu.au/research/publications/3626/governance-health-safety-and-quality 2005

References

1. World Health Organization. Quality of care. Accessed on May 17, 2023. www.who.int/health-topics/quality-of-care#tab=tab_1

2. World Health Organization. Patient safety. Accessed on May 17, 2023 www.who.int/news-room/fact-sheets/detail/patient-safety

3. Agency for Healthcare Research and Quality. Understanding quality measurement. Accessed on May 17, 2023. www.ahrq.gov/patient-safety/quality-resources/tools/chtoolbx/understand/index.html

4. Ferrell B, Connor SR, Cordes A, et al. The national agenda for quality palliative care: the National Consensus Project and the National Quality Forum. J Pain Symptom Manage. 2007;33(6):737-744. doi:10.1016/j.jpainsymman.2007.02.024

5. U.S Centers for Medicare & Medicaid Services. Quality payment program. Accessed on March 14, 2023 qpp.cms.gov/mips/overview

6. Claxton K, Martin S, Soares M, et al. Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold. Health Technol Assess. 2015;19(14):1-503, v-vi. doi: 10.3310/hta19140

7. Braithwaite J, Healy J, Dwan K. The Governance of Health Safety and Quality, Commonwealth of Australia. Accessed May 17, 2023. https://regnet.anu.edu.au/research/publications/3626/governance-health-safety-and-quality 2005

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The Mission of Continuous Improvement in Health Care: A New Era for Clinical Outcomes Management

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This issue of the Journal of Clinical Outcomes (JCOM) debuts a new cover design that brings forward the articles and features in each issue. Although the Journal’s cover has a new look, JCOM’s goals remain the same—improving care by disseminating evidence of quality improvement in health care and sharing access to the medical literature with our readers. We continue our mission to promote the best medical practice by providing clinicians with updates and communicating advances that lead to measurable improvement in health care delivery, quality, and outcomes.

As we continue the work of improving health care quality, knowledge gaps and unmet needs in the literature remain. These unmet needs are evident throughout all phases of health care delivery. Moreover, the Institutes of Medicine report that centered on efforts to build a safer health care environment by redesigning health care processes remains salient.1 The journey to continuous improvement in health care, where we achieve threshold change in the quality of each process and across the entire health care system, requires collective effort. Such efforts include establishing clear metrics and measurements for improvement goals throughout the patient’s journey through diagnosis, treatment, transitions of care, and disease management.2,3 To address evidence and knowledge gaps in the literature, JCOM publishes reports of original studies and quality improvement projects as well as reviews, providing its 30,000 readers with new evidence to implement in daily practice. We welcome submissions of original research reports, reports of quality improvement projects that follow the SQUIRE 2.0 standards,4 and perspectives on developments and innovations in health care delivery.

The next chapter in health care delivery improvement will encompass value-based care.5 This new era of clinical outcomes management will dictate the metrics and outcomes reporting6 and how to plan future investments. The value-based phase will increase innovation and shape policies that advance population health, transforming every step in the care delivery journey.7 The next phase in health care delivery will also create a viable financial structure while implementing effective performance measures for optimal outcomes through patient-centered care and optimization of cost and care strategies. In light of health care’s evolution toward a value-based model, JCOM welcomes submissions of manuscripts that explore themes central to this model, including patient-centered care, implementation of best practices, system design, safety, cost-effectiveness, and the balance between cost optimization and quality. For JCOM’s authors and readers, our editorial team remains commited to the highest standards in timely publishing to support our community through our collective expertise and dedication to quality improvement.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

References

1. Institute of Medicine (US) Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000.

2. Singh H, Sittig DF. Advancing the science of measurement of diagnostic errors in healthcare: the Safer Dx framework. BMJ Qual Saf. 2015;24(2):103-10. doi:10.1136/bmjqs-2014-003675

3. Bates DW. Preventing medication errors: a summary. Am J Health Syst Pharm. 2007;64(14 Suppl 9):S3-9. doi:10.2146/ajhp070190

4. Revised Standards for Quality Improvement Reporting Excellence. SQUIRE 2.0. Accessed July 25, 2022. http://squire-statement.org

5. Gray M. Value based healthcare. BMJ. 2017;356:j437. doi:10.1136/bmj.j437

6. What is value-based healthcare? NEJM Catalyst. January 1, 2017. Accessed July 25, 2022. catalyst.nejm.org/doi/full/10.1056/CAT.17.0558

7. Porter ME, Teisberg EO. Redefining Health Care: Creating Value-Based Competition on Results. Harvard Business Press; 2006.

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This issue of the Journal of Clinical Outcomes (JCOM) debuts a new cover design that brings forward the articles and features in each issue. Although the Journal’s cover has a new look, JCOM’s goals remain the same—improving care by disseminating evidence of quality improvement in health care and sharing access to the medical literature with our readers. We continue our mission to promote the best medical practice by providing clinicians with updates and communicating advances that lead to measurable improvement in health care delivery, quality, and outcomes.

As we continue the work of improving health care quality, knowledge gaps and unmet needs in the literature remain. These unmet needs are evident throughout all phases of health care delivery. Moreover, the Institutes of Medicine report that centered on efforts to build a safer health care environment by redesigning health care processes remains salient.1 The journey to continuous improvement in health care, where we achieve threshold change in the quality of each process and across the entire health care system, requires collective effort. Such efforts include establishing clear metrics and measurements for improvement goals throughout the patient’s journey through diagnosis, treatment, transitions of care, and disease management.2,3 To address evidence and knowledge gaps in the literature, JCOM publishes reports of original studies and quality improvement projects as well as reviews, providing its 30,000 readers with new evidence to implement in daily practice. We welcome submissions of original research reports, reports of quality improvement projects that follow the SQUIRE 2.0 standards,4 and perspectives on developments and innovations in health care delivery.

The next chapter in health care delivery improvement will encompass value-based care.5 This new era of clinical outcomes management will dictate the metrics and outcomes reporting6 and how to plan future investments. The value-based phase will increase innovation and shape policies that advance population health, transforming every step in the care delivery journey.7 The next phase in health care delivery will also create a viable financial structure while implementing effective performance measures for optimal outcomes through patient-centered care and optimization of cost and care strategies. In light of health care’s evolution toward a value-based model, JCOM welcomes submissions of manuscripts that explore themes central to this model, including patient-centered care, implementation of best practices, system design, safety, cost-effectiveness, and the balance between cost optimization and quality. For JCOM’s authors and readers, our editorial team remains commited to the highest standards in timely publishing to support our community through our collective expertise and dedication to quality improvement.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

This issue of the Journal of Clinical Outcomes (JCOM) debuts a new cover design that brings forward the articles and features in each issue. Although the Journal’s cover has a new look, JCOM’s goals remain the same—improving care by disseminating evidence of quality improvement in health care and sharing access to the medical literature with our readers. We continue our mission to promote the best medical practice by providing clinicians with updates and communicating advances that lead to measurable improvement in health care delivery, quality, and outcomes.

As we continue the work of improving health care quality, knowledge gaps and unmet needs in the literature remain. These unmet needs are evident throughout all phases of health care delivery. Moreover, the Institutes of Medicine report that centered on efforts to build a safer health care environment by redesigning health care processes remains salient.1 The journey to continuous improvement in health care, where we achieve threshold change in the quality of each process and across the entire health care system, requires collective effort. Such efforts include establishing clear metrics and measurements for improvement goals throughout the patient’s journey through diagnosis, treatment, transitions of care, and disease management.2,3 To address evidence and knowledge gaps in the literature, JCOM publishes reports of original studies and quality improvement projects as well as reviews, providing its 30,000 readers with new evidence to implement in daily practice. We welcome submissions of original research reports, reports of quality improvement projects that follow the SQUIRE 2.0 standards,4 and perspectives on developments and innovations in health care delivery.

The next chapter in health care delivery improvement will encompass value-based care.5 This new era of clinical outcomes management will dictate the metrics and outcomes reporting6 and how to plan future investments. The value-based phase will increase innovation and shape policies that advance population health, transforming every step in the care delivery journey.7 The next phase in health care delivery will also create a viable financial structure while implementing effective performance measures for optimal outcomes through patient-centered care and optimization of cost and care strategies. In light of health care’s evolution toward a value-based model, JCOM welcomes submissions of manuscripts that explore themes central to this model, including patient-centered care, implementation of best practices, system design, safety, cost-effectiveness, and the balance between cost optimization and quality. For JCOM’s authors and readers, our editorial team remains commited to the highest standards in timely publishing to support our community through our collective expertise and dedication to quality improvement.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

References

1. Institute of Medicine (US) Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000.

2. Singh H, Sittig DF. Advancing the science of measurement of diagnostic errors in healthcare: the Safer Dx framework. BMJ Qual Saf. 2015;24(2):103-10. doi:10.1136/bmjqs-2014-003675

3. Bates DW. Preventing medication errors: a summary. Am J Health Syst Pharm. 2007;64(14 Suppl 9):S3-9. doi:10.2146/ajhp070190

4. Revised Standards for Quality Improvement Reporting Excellence. SQUIRE 2.0. Accessed July 25, 2022. http://squire-statement.org

5. Gray M. Value based healthcare. BMJ. 2017;356:j437. doi:10.1136/bmj.j437

6. What is value-based healthcare? NEJM Catalyst. January 1, 2017. Accessed July 25, 2022. catalyst.nejm.org/doi/full/10.1056/CAT.17.0558

7. Porter ME, Teisberg EO. Redefining Health Care: Creating Value-Based Competition on Results. Harvard Business Press; 2006.

References

1. Institute of Medicine (US) Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000.

2. Singh H, Sittig DF. Advancing the science of measurement of diagnostic errors in healthcare: the Safer Dx framework. BMJ Qual Saf. 2015;24(2):103-10. doi:10.1136/bmjqs-2014-003675

3. Bates DW. Preventing medication errors: a summary. Am J Health Syst Pharm. 2007;64(14 Suppl 9):S3-9. doi:10.2146/ajhp070190

4. Revised Standards for Quality Improvement Reporting Excellence. SQUIRE 2.0. Accessed July 25, 2022. http://squire-statement.org

5. Gray M. Value based healthcare. BMJ. 2017;356:j437. doi:10.1136/bmj.j437

6. What is value-based healthcare? NEJM Catalyst. January 1, 2017. Accessed July 25, 2022. catalyst.nejm.org/doi/full/10.1056/CAT.17.0558

7. Porter ME, Teisberg EO. Redefining Health Care: Creating Value-Based Competition on Results. Harvard Business Press; 2006.

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The Intersection of Clinical Quality Improvement Research and Implementation Science

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The Institute of Medicine brought much-needed attention to the need for process improvement in medicine with its seminal report To Err Is Human: Building a Safer Health System, which was issued in 1999, leading to the quality movement’s call to close health care performance gaps in Crossing the Quality Chasm: A New Health System for the 21st Century.1,2 Quality improvement science in medicine has evolved over the past 2 decades to include a broad spectrum of approaches, from agile improvement to continuous learning and improvement. Current efforts focus on Lean-based process improvement along with a reduction in variation in clinical practice to align practice with the principles of evidence-based medicine in a patient-centered approach.3 Further, the definition of quality improvement under the Affordable Care Act was framed as an equitable, timely, value-based, patient-centered approach to achieving population-level health goals.4 Thus, the science of quality improvement drives the core principles of care delivery improvement, and the rigorous evidence needed to expand innovation is embedded within the same framework.5,6 In clinical practice, quality improvement projects aim to define gaps and then specific steps are undertaken to improve the evidence-based practice of a specific process. The overarching goal is to enhance the efficacy of the practice by reducing waste within a particular domain. Thus, quality improvement and implementation research eventually unify how clinical practice is advanced concurrently to bridge identified gaps.7

System redesign through a patient-centered framework forms the core of an overarching strategy to support system-level processes. Both require a deep understanding of the fields of quality improvement science and implementation science.8 Furthermore, aligning clinical research needs, system aims, patients’ values, and clinical care give the new design a clear path forward. Patient-centered improvement includes the essential elements of system redesign around human factors, including communication, physical resources, and updated information during episodes of care. The patient-centered improvement design is juxtaposed with care planning and establishing continuum of care processes.9 It is essential to note that safety is rooted within the quality domain as a top priority in medicine.10 The best implementation methods and approaches are discussed and debated, and the improvement progress continues on multiple fronts.11 Patient safety systems are implemented simultaneously during the redesign phase. Moreover, identifying and testing the health care delivery methods in the era of competing strategic priorities to achieve the desirable clinical outcomes highlights the importance of implementation, while contemplating the methods of dissemination, scalability, and sustainability of the best evidence-based clinical practice.

The cycle of quality improvement research completes the system implementation efforts. The conceptual framework of quality improvement includes multiple areas of care and transition, along with applying the best clinical practices in a culture that emphasizes continuous improvement and learning. At the same time, the operating principles should include continuous improvement in a simple and continuous system of learning as a core concept. Our proposed implementation approach involves taking simple and practical steps while separating the process from the outcomes measures, extracting effectiveness throughout the process. It is essential to keep in mind that building a proactive and systematic improvement environment requires a framework for safety, reliability, and effective care, as well as the alignment of the physical system, communication, and professional environment and culture (Figure).

The intersection of clinical quality improvement research and implementation science

In summary, system design for quality improvement research should incorporate the principles and conceptual framework that embody effective implementation strategies, with a focus on operational and practical steps. Continuous improvement will be reached through the multidimensional development of current health care system metrics and the incorporation of implementation science methods.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

Disclosures: None reported.

References

1. Institute of Medicine (US) Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. Kohn LT, Corrigan JM, Donaldson MS, editors. Washington (DC): National Academies Press (US); 2000.

2. Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001.

3. Berwick DM. The science of improvement. JAMA. 2008;299(10):1182-1184. doi:10.1001/jama.299.10.1182

4. Mazurenko O, Balio CP, Agarwal R, Carroll AE, Menachemi N. The effects of Medicaid expansion under the ACA: a systematic review. Health Affairs. 2018;37(6):944-950. doi: 10.1377/hlthaff.2017.1491

5. Fan E, Needham DM. The science of quality improvement. JAMA. 2008;300(4):390-391. doi:10.1001/jama.300.4.390-b

6. Alexander JA, Hearld LR. The science of quality improvement implementation: developing capacity to make a difference. Med Care. 2011:S6-20. doi:10.1097/MLR.0b013e3181e1709c

7. Rohweder C, Wangen M, Black M, et al. Understanding quality improvement collaboratives through an implementation science lens. Prev Med. 2019;129:105859. doi: 10.1016/j.ypmed.2019.105859

8. Bergeson SC, Dean JD. A systems approach to patient-centered care. JAMA. 2006;296(23):2848-2851. doi:10.1001/jama.296.23.2848

9. Leonard M, Graham S, Bonacum D. The human factor: the critical importance of effective teamwork and communication in providing safe care. Qual Saf Health Care. 2004;13 Suppl 1(Suppl 1):i85-90. doi:10.1136/qhc.13.suppl_1.i85

10. Leape LL, Berwick DM, Bates DW. What practices will most improve safety? Evidence-based medicine meets patient safety. JAMA. 2002;288(4):501-507. doi:10.1001/jama.288.4.501

11. Auerbach AD, Landefeld CS, Shojania KG. The tension between needing to improve care and knowing how to do it. N Engl J Med. 2007;357(6):608-613. doi:10.1056/NEJMsb070738

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The Institute of Medicine brought much-needed attention to the need for process improvement in medicine with its seminal report To Err Is Human: Building a Safer Health System, which was issued in 1999, leading to the quality movement’s call to close health care performance gaps in Crossing the Quality Chasm: A New Health System for the 21st Century.1,2 Quality improvement science in medicine has evolved over the past 2 decades to include a broad spectrum of approaches, from agile improvement to continuous learning and improvement. Current efforts focus on Lean-based process improvement along with a reduction in variation in clinical practice to align practice with the principles of evidence-based medicine in a patient-centered approach.3 Further, the definition of quality improvement under the Affordable Care Act was framed as an equitable, timely, value-based, patient-centered approach to achieving population-level health goals.4 Thus, the science of quality improvement drives the core principles of care delivery improvement, and the rigorous evidence needed to expand innovation is embedded within the same framework.5,6 In clinical practice, quality improvement projects aim to define gaps and then specific steps are undertaken to improve the evidence-based practice of a specific process. The overarching goal is to enhance the efficacy of the practice by reducing waste within a particular domain. Thus, quality improvement and implementation research eventually unify how clinical practice is advanced concurrently to bridge identified gaps.7

System redesign through a patient-centered framework forms the core of an overarching strategy to support system-level processes. Both require a deep understanding of the fields of quality improvement science and implementation science.8 Furthermore, aligning clinical research needs, system aims, patients’ values, and clinical care give the new design a clear path forward. Patient-centered improvement includes the essential elements of system redesign around human factors, including communication, physical resources, and updated information during episodes of care. The patient-centered improvement design is juxtaposed with care planning and establishing continuum of care processes.9 It is essential to note that safety is rooted within the quality domain as a top priority in medicine.10 The best implementation methods and approaches are discussed and debated, and the improvement progress continues on multiple fronts.11 Patient safety systems are implemented simultaneously during the redesign phase. Moreover, identifying and testing the health care delivery methods in the era of competing strategic priorities to achieve the desirable clinical outcomes highlights the importance of implementation, while contemplating the methods of dissemination, scalability, and sustainability of the best evidence-based clinical practice.

The cycle of quality improvement research completes the system implementation efforts. The conceptual framework of quality improvement includes multiple areas of care and transition, along with applying the best clinical practices in a culture that emphasizes continuous improvement and learning. At the same time, the operating principles should include continuous improvement in a simple and continuous system of learning as a core concept. Our proposed implementation approach involves taking simple and practical steps while separating the process from the outcomes measures, extracting effectiveness throughout the process. It is essential to keep in mind that building a proactive and systematic improvement environment requires a framework for safety, reliability, and effective care, as well as the alignment of the physical system, communication, and professional environment and culture (Figure).

The intersection of clinical quality improvement research and implementation science

In summary, system design for quality improvement research should incorporate the principles and conceptual framework that embody effective implementation strategies, with a focus on operational and practical steps. Continuous improvement will be reached through the multidimensional development of current health care system metrics and the incorporation of implementation science methods.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

Disclosures: None reported.

The Institute of Medicine brought much-needed attention to the need for process improvement in medicine with its seminal report To Err Is Human: Building a Safer Health System, which was issued in 1999, leading to the quality movement’s call to close health care performance gaps in Crossing the Quality Chasm: A New Health System for the 21st Century.1,2 Quality improvement science in medicine has evolved over the past 2 decades to include a broad spectrum of approaches, from agile improvement to continuous learning and improvement. Current efforts focus on Lean-based process improvement along with a reduction in variation in clinical practice to align practice with the principles of evidence-based medicine in a patient-centered approach.3 Further, the definition of quality improvement under the Affordable Care Act was framed as an equitable, timely, value-based, patient-centered approach to achieving population-level health goals.4 Thus, the science of quality improvement drives the core principles of care delivery improvement, and the rigorous evidence needed to expand innovation is embedded within the same framework.5,6 In clinical practice, quality improvement projects aim to define gaps and then specific steps are undertaken to improve the evidence-based practice of a specific process. The overarching goal is to enhance the efficacy of the practice by reducing waste within a particular domain. Thus, quality improvement and implementation research eventually unify how clinical practice is advanced concurrently to bridge identified gaps.7

System redesign through a patient-centered framework forms the core of an overarching strategy to support system-level processes. Both require a deep understanding of the fields of quality improvement science and implementation science.8 Furthermore, aligning clinical research needs, system aims, patients’ values, and clinical care give the new design a clear path forward. Patient-centered improvement includes the essential elements of system redesign around human factors, including communication, physical resources, and updated information during episodes of care. The patient-centered improvement design is juxtaposed with care planning and establishing continuum of care processes.9 It is essential to note that safety is rooted within the quality domain as a top priority in medicine.10 The best implementation methods and approaches are discussed and debated, and the improvement progress continues on multiple fronts.11 Patient safety systems are implemented simultaneously during the redesign phase. Moreover, identifying and testing the health care delivery methods in the era of competing strategic priorities to achieve the desirable clinical outcomes highlights the importance of implementation, while contemplating the methods of dissemination, scalability, and sustainability of the best evidence-based clinical practice.

The cycle of quality improvement research completes the system implementation efforts. The conceptual framework of quality improvement includes multiple areas of care and transition, along with applying the best clinical practices in a culture that emphasizes continuous improvement and learning. At the same time, the operating principles should include continuous improvement in a simple and continuous system of learning as a core concept. Our proposed implementation approach involves taking simple and practical steps while separating the process from the outcomes measures, extracting effectiveness throughout the process. It is essential to keep in mind that building a proactive and systematic improvement environment requires a framework for safety, reliability, and effective care, as well as the alignment of the physical system, communication, and professional environment and culture (Figure).

The intersection of clinical quality improvement research and implementation science

In summary, system design for quality improvement research should incorporate the principles and conceptual framework that embody effective implementation strategies, with a focus on operational and practical steps. Continuous improvement will be reached through the multidimensional development of current health care system metrics and the incorporation of implementation science methods.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine, Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

Disclosures: None reported.

References

1. Institute of Medicine (US) Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. Kohn LT, Corrigan JM, Donaldson MS, editors. Washington (DC): National Academies Press (US); 2000.

2. Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001.

3. Berwick DM. The science of improvement. JAMA. 2008;299(10):1182-1184. doi:10.1001/jama.299.10.1182

4. Mazurenko O, Balio CP, Agarwal R, Carroll AE, Menachemi N. The effects of Medicaid expansion under the ACA: a systematic review. Health Affairs. 2018;37(6):944-950. doi: 10.1377/hlthaff.2017.1491

5. Fan E, Needham DM. The science of quality improvement. JAMA. 2008;300(4):390-391. doi:10.1001/jama.300.4.390-b

6. Alexander JA, Hearld LR. The science of quality improvement implementation: developing capacity to make a difference. Med Care. 2011:S6-20. doi:10.1097/MLR.0b013e3181e1709c

7. Rohweder C, Wangen M, Black M, et al. Understanding quality improvement collaboratives through an implementation science lens. Prev Med. 2019;129:105859. doi: 10.1016/j.ypmed.2019.105859

8. Bergeson SC, Dean JD. A systems approach to patient-centered care. JAMA. 2006;296(23):2848-2851. doi:10.1001/jama.296.23.2848

9. Leonard M, Graham S, Bonacum D. The human factor: the critical importance of effective teamwork and communication in providing safe care. Qual Saf Health Care. 2004;13 Suppl 1(Suppl 1):i85-90. doi:10.1136/qhc.13.suppl_1.i85

10. Leape LL, Berwick DM, Bates DW. What practices will most improve safety? Evidence-based medicine meets patient safety. JAMA. 2002;288(4):501-507. doi:10.1001/jama.288.4.501

11. Auerbach AD, Landefeld CS, Shojania KG. The tension between needing to improve care and knowing how to do it. N Engl J Med. 2007;357(6):608-613. doi:10.1056/NEJMsb070738

References

1. Institute of Medicine (US) Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. Kohn LT, Corrigan JM, Donaldson MS, editors. Washington (DC): National Academies Press (US); 2000.

2. Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001.

3. Berwick DM. The science of improvement. JAMA. 2008;299(10):1182-1184. doi:10.1001/jama.299.10.1182

4. Mazurenko O, Balio CP, Agarwal R, Carroll AE, Menachemi N. The effects of Medicaid expansion under the ACA: a systematic review. Health Affairs. 2018;37(6):944-950. doi: 10.1377/hlthaff.2017.1491

5. Fan E, Needham DM. The science of quality improvement. JAMA. 2008;300(4):390-391. doi:10.1001/jama.300.4.390-b

6. Alexander JA, Hearld LR. The science of quality improvement implementation: developing capacity to make a difference. Med Care. 2011:S6-20. doi:10.1097/MLR.0b013e3181e1709c

7. Rohweder C, Wangen M, Black M, et al. Understanding quality improvement collaboratives through an implementation science lens. Prev Med. 2019;129:105859. doi: 10.1016/j.ypmed.2019.105859

8. Bergeson SC, Dean JD. A systems approach to patient-centered care. JAMA. 2006;296(23):2848-2851. doi:10.1001/jama.296.23.2848

9. Leonard M, Graham S, Bonacum D. The human factor: the critical importance of effective teamwork and communication in providing safe care. Qual Saf Health Care. 2004;13 Suppl 1(Suppl 1):i85-90. doi:10.1136/qhc.13.suppl_1.i85

10. Leape LL, Berwick DM, Bates DW. What practices will most improve safety? Evidence-based medicine meets patient safety. JAMA. 2002;288(4):501-507. doi:10.1001/jama.288.4.501

11. Auerbach AD, Landefeld CS, Shojania KG. The tension between needing to improve care and knowing how to do it. N Engl J Med. 2007;357(6):608-613. doi:10.1056/NEJMsb070738

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Aiming for System Improvement While Transitioning to the New Normal

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As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al1 reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al2 explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al3 report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al4 discuss efforts to improve comorbidity capture at their institution, and Uche et al5 present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

References

1. Liesching TN, Lei Y. Oxygen therapies and clinical outcomes for patients hospitalized with covid-19: first surge vs second surge. J Clin Outcomes Manag. 2022;29(2):58-64. doi:10.12788/jcom.0086

2. Ali SH, Hyer S, Davis K, Murrow JR. Acute STEMI during the COVID-19 pandemic at Piedmont Athens Regional: incidence, clinical characteristics, and outcomes. J Clin Outcomes Manag. 2022;29(2):65-71. doi:10.12788/jcom.0085

3. Cusick A, Hanigan S, Bashaw L, et al. A practical and cost-effective approach to the diagnosis of heparin-induced thrombocytopenia: a single-center quality improvement study. J Clin Outcomes Manag. 2022;29(2):72-77.

4. Sosa MA, Ferreira T, Gershengorn H, et al. Improving hospital metrics through the implementation of a comorbidity capture tool and other quality initiatives. J Clin Outcomes Manag. 2022;29(2):80-87. doi:10.12788/jcom.00885. Uche JU, Jamison M, Waugh S. Evaluation of the Empower Veterans Program for military veterans with chronic pain. J Clin Outcomes Manag. 2022;29(2):88-95. doi:10.12788/jcom.0089

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As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al1 reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al2 explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al3 report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al4 discuss efforts to improve comorbidity capture at their institution, and Uche et al5 present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al1 reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al2 explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al3 report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al4 discuss efforts to improve comorbidity capture at their institution, and Uche et al5 present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; ebarkoudah@bwh.harvard.edu

References

1. Liesching TN, Lei Y. Oxygen therapies and clinical outcomes for patients hospitalized with covid-19: first surge vs second surge. J Clin Outcomes Manag. 2022;29(2):58-64. doi:10.12788/jcom.0086

2. Ali SH, Hyer S, Davis K, Murrow JR. Acute STEMI during the COVID-19 pandemic at Piedmont Athens Regional: incidence, clinical characteristics, and outcomes. J Clin Outcomes Manag. 2022;29(2):65-71. doi:10.12788/jcom.0085

3. Cusick A, Hanigan S, Bashaw L, et al. A practical and cost-effective approach to the diagnosis of heparin-induced thrombocytopenia: a single-center quality improvement study. J Clin Outcomes Manag. 2022;29(2):72-77.

4. Sosa MA, Ferreira T, Gershengorn H, et al. Improving hospital metrics through the implementation of a comorbidity capture tool and other quality initiatives. J Clin Outcomes Manag. 2022;29(2):80-87. doi:10.12788/jcom.00885. Uche JU, Jamison M, Waugh S. Evaluation of the Empower Veterans Program for military veterans with chronic pain. J Clin Outcomes Manag. 2022;29(2):88-95. doi:10.12788/jcom.0089

References

1. Liesching TN, Lei Y. Oxygen therapies and clinical outcomes for patients hospitalized with covid-19: first surge vs second surge. J Clin Outcomes Manag. 2022;29(2):58-64. doi:10.12788/jcom.0086

2. Ali SH, Hyer S, Davis K, Murrow JR. Acute STEMI during the COVID-19 pandemic at Piedmont Athens Regional: incidence, clinical characteristics, and outcomes. J Clin Outcomes Manag. 2022;29(2):65-71. doi:10.12788/jcom.0085

3. Cusick A, Hanigan S, Bashaw L, et al. A practical and cost-effective approach to the diagnosis of heparin-induced thrombocytopenia: a single-center quality improvement study. J Clin Outcomes Manag. 2022;29(2):72-77.

4. Sosa MA, Ferreira T, Gershengorn H, et al. Improving hospital metrics through the implementation of a comorbidity capture tool and other quality initiatives. J Clin Outcomes Manag. 2022;29(2):80-87. doi:10.12788/jcom.00885. Uche JU, Jamison M, Waugh S. Evaluation of the Empower Veterans Program for military veterans with chronic pain. J Clin Outcomes Manag. 2022;29(2):88-95. doi:10.12788/jcom.0089

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Simulation-Based Training in Medical Education: Immediate Growth or Cautious Optimism?

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For years, professional athletes have used simulation-based training (SBT), a combination of virtual and experiential learning that aims to optimize technical skills, teamwork, and communication.1 In SBT, critical plays and skills are first watched on video or reviewed on a chalkboard, and then run in the presence of a coach who offers immediate feedback to the player. The hope is that the individual will then be able to perfectly execute that play or scenario when it is game time. While SBT is a developing tool in medical education—allowing learners to practice important clinical skills prior to practicing in the higher-stakes clinical environment—an important question remains: what training can go virtual and what needs to stay in person?

In this issue, Carter et al2 present a single-site, telesimulation curriculum that addresses consult request and handoff communication using SBT. Due to the COVID-19 pandemic, the authors converted an in-person intern bootcamp into a virtual, Zoom®-based workshop and compared assessments and evaluations to the previous year’s (2019) in-person bootcamp. Compared to the in-person class, the telesimulation-based cohort were equally or better trained in the consult request portion of the workshop. However, participants were significantly less likely to perform the assessed handoff skills optimally, with only a quarter (26%) appropriately prioritizing patients and less than half (49%) providing an appropriate amount of information in the patient summary. Additionally, postworkshop surveys found that SBT participants were more satisfied with their performance in both the consult request and handoff scenarios and felt more prepared (99% vs 91%) to perform handoffs in clinical practice compared to the previous year’s in-person cohort.

We focus on this work as it explores the role that SBT or virtual training could have in hospital communication and patient safety training. While previous work has highlighted that technical and procedural skills often lend themselves to in-person adaptation (eg, point-of-care ultrasound), this work suggests that nontechnical skills training could be adapted to the virtual environment. Hospitalists and internal medicine trainees perform a myriad of nontechnical activities, such as end-of-life discussions, obtaining informed consent, providing peer-to-peer feedback, and leading multidisciplinary teams. Activities like these, which require no hands-on interactions, may be well-suited for simulation or virtual-based training.3

However, we make this suggestion with some caution. In Carter et al’s study,2 while we assumed that telesimulation would work for the handoff portion of the workshop, interestingly, the telesimulation-based cohort performed worse than the interns who participated in the previous year’s in-person training while simultaneously and paradoxically reporting that they felt more prepared. The authors offer several possible explanations, including alterations in the assessment checklist and a shift in the facilitators from peer observers to faculty hospitalists. We suspect that differences in the participants’ experiences prior to the bootcamp may also be at play. Given the onset of the pandemic during their final year in undergraduate training, many in this intern cohort were likely removed from their fourth-year clinical clerkships,4 taking from them pivotal opportunities to hone and refine this skill set prior to starting their graduate medical education.

As telesimulation and other virtual care educational opportunities continue to evolve, we must ensure that such training does not sacrifice quality for ease and satisfaction. As the authors’ findings show, simply replicating an in-person curriculum in a virtual environment does not ensure equivalence for all skill sets. We remain cautiously optimistic that as we adjust to a postpandemic world, more SBT and virtual-based educational interventions will allow medical trainees to be ready to perform come game time.

References

1. McCaskill S. Sports tech comes of age with VR training, coaching apps and smart gear. Forbes. March 31, 2020. https://www.forbes.com/sites/stevemccaskill/2020/03/31/sports-tech-comes-of-age-with-vr-training-coaching-apps-and-smart-gear/?sh=309a8fa219c9
2. Carter K, Podczerwinski J, Love L, et al. Utilizing telesimulation for advanced skills training in consultation and handoff communication: a post-COVID-19 GME bootcamp experience. J Hosp Med. 2021;16(12)730-734. https://doi.org/10.12788/jhm.3733
3. Paige JT, Sonesh SC, Garbee DD, Bonanno LS. Comprensive Healthcare Simulation: Interprofessional Team Training and Simulation. 1st ed. Springer International Publishing; 2020. https://doi.org/10.1007/978-3-030-28845-7
4. Goldenberg MN, Hersh DC, Wilkins KM, Schwartz ML. Suspending medical student clerkships due to COVID-19. Med Sci Educ. 2020;30(3):1-4. https://doi.org/10.1007/s40670-020-00994-1

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For years, professional athletes have used simulation-based training (SBT), a combination of virtual and experiential learning that aims to optimize technical skills, teamwork, and communication.1 In SBT, critical plays and skills are first watched on video or reviewed on a chalkboard, and then run in the presence of a coach who offers immediate feedback to the player. The hope is that the individual will then be able to perfectly execute that play or scenario when it is game time. While SBT is a developing tool in medical education—allowing learners to practice important clinical skills prior to practicing in the higher-stakes clinical environment—an important question remains: what training can go virtual and what needs to stay in person?

In this issue, Carter et al2 present a single-site, telesimulation curriculum that addresses consult request and handoff communication using SBT. Due to the COVID-19 pandemic, the authors converted an in-person intern bootcamp into a virtual, Zoom®-based workshop and compared assessments and evaluations to the previous year’s (2019) in-person bootcamp. Compared to the in-person class, the telesimulation-based cohort were equally or better trained in the consult request portion of the workshop. However, participants were significantly less likely to perform the assessed handoff skills optimally, with only a quarter (26%) appropriately prioritizing patients and less than half (49%) providing an appropriate amount of information in the patient summary. Additionally, postworkshop surveys found that SBT participants were more satisfied with their performance in both the consult request and handoff scenarios and felt more prepared (99% vs 91%) to perform handoffs in clinical practice compared to the previous year’s in-person cohort.

We focus on this work as it explores the role that SBT or virtual training could have in hospital communication and patient safety training. While previous work has highlighted that technical and procedural skills often lend themselves to in-person adaptation (eg, point-of-care ultrasound), this work suggests that nontechnical skills training could be adapted to the virtual environment. Hospitalists and internal medicine trainees perform a myriad of nontechnical activities, such as end-of-life discussions, obtaining informed consent, providing peer-to-peer feedback, and leading multidisciplinary teams. Activities like these, which require no hands-on interactions, may be well-suited for simulation or virtual-based training.3

However, we make this suggestion with some caution. In Carter et al’s study,2 while we assumed that telesimulation would work for the handoff portion of the workshop, interestingly, the telesimulation-based cohort performed worse than the interns who participated in the previous year’s in-person training while simultaneously and paradoxically reporting that they felt more prepared. The authors offer several possible explanations, including alterations in the assessment checklist and a shift in the facilitators from peer observers to faculty hospitalists. We suspect that differences in the participants’ experiences prior to the bootcamp may also be at play. Given the onset of the pandemic during their final year in undergraduate training, many in this intern cohort were likely removed from their fourth-year clinical clerkships,4 taking from them pivotal opportunities to hone and refine this skill set prior to starting their graduate medical education.

As telesimulation and other virtual care educational opportunities continue to evolve, we must ensure that such training does not sacrifice quality for ease and satisfaction. As the authors’ findings show, simply replicating an in-person curriculum in a virtual environment does not ensure equivalence for all skill sets. We remain cautiously optimistic that as we adjust to a postpandemic world, more SBT and virtual-based educational interventions will allow medical trainees to be ready to perform come game time.

For years, professional athletes have used simulation-based training (SBT), a combination of virtual and experiential learning that aims to optimize technical skills, teamwork, and communication.1 In SBT, critical plays and skills are first watched on video or reviewed on a chalkboard, and then run in the presence of a coach who offers immediate feedback to the player. The hope is that the individual will then be able to perfectly execute that play or scenario when it is game time. While SBT is a developing tool in medical education—allowing learners to practice important clinical skills prior to practicing in the higher-stakes clinical environment—an important question remains: what training can go virtual and what needs to stay in person?

In this issue, Carter et al2 present a single-site, telesimulation curriculum that addresses consult request and handoff communication using SBT. Due to the COVID-19 pandemic, the authors converted an in-person intern bootcamp into a virtual, Zoom®-based workshop and compared assessments and evaluations to the previous year’s (2019) in-person bootcamp. Compared to the in-person class, the telesimulation-based cohort were equally or better trained in the consult request portion of the workshop. However, participants were significantly less likely to perform the assessed handoff skills optimally, with only a quarter (26%) appropriately prioritizing patients and less than half (49%) providing an appropriate amount of information in the patient summary. Additionally, postworkshop surveys found that SBT participants were more satisfied with their performance in both the consult request and handoff scenarios and felt more prepared (99% vs 91%) to perform handoffs in clinical practice compared to the previous year’s in-person cohort.

We focus on this work as it explores the role that SBT or virtual training could have in hospital communication and patient safety training. While previous work has highlighted that technical and procedural skills often lend themselves to in-person adaptation (eg, point-of-care ultrasound), this work suggests that nontechnical skills training could be adapted to the virtual environment. Hospitalists and internal medicine trainees perform a myriad of nontechnical activities, such as end-of-life discussions, obtaining informed consent, providing peer-to-peer feedback, and leading multidisciplinary teams. Activities like these, which require no hands-on interactions, may be well-suited for simulation or virtual-based training.3

However, we make this suggestion with some caution. In Carter et al’s study,2 while we assumed that telesimulation would work for the handoff portion of the workshop, interestingly, the telesimulation-based cohort performed worse than the interns who participated in the previous year’s in-person training while simultaneously and paradoxically reporting that they felt more prepared. The authors offer several possible explanations, including alterations in the assessment checklist and a shift in the facilitators from peer observers to faculty hospitalists. We suspect that differences in the participants’ experiences prior to the bootcamp may also be at play. Given the onset of the pandemic during their final year in undergraduate training, many in this intern cohort were likely removed from their fourth-year clinical clerkships,4 taking from them pivotal opportunities to hone and refine this skill set prior to starting their graduate medical education.

As telesimulation and other virtual care educational opportunities continue to evolve, we must ensure that such training does not sacrifice quality for ease and satisfaction. As the authors’ findings show, simply replicating an in-person curriculum in a virtual environment does not ensure equivalence for all skill sets. We remain cautiously optimistic that as we adjust to a postpandemic world, more SBT and virtual-based educational interventions will allow medical trainees to be ready to perform come game time.

References

1. McCaskill S. Sports tech comes of age with VR training, coaching apps and smart gear. Forbes. March 31, 2020. https://www.forbes.com/sites/stevemccaskill/2020/03/31/sports-tech-comes-of-age-with-vr-training-coaching-apps-and-smart-gear/?sh=309a8fa219c9
2. Carter K, Podczerwinski J, Love L, et al. Utilizing telesimulation for advanced skills training in consultation and handoff communication: a post-COVID-19 GME bootcamp experience. J Hosp Med. 2021;16(12)730-734. https://doi.org/10.12788/jhm.3733
3. Paige JT, Sonesh SC, Garbee DD, Bonanno LS. Comprensive Healthcare Simulation: Interprofessional Team Training and Simulation. 1st ed. Springer International Publishing; 2020. https://doi.org/10.1007/978-3-030-28845-7
4. Goldenberg MN, Hersh DC, Wilkins KM, Schwartz ML. Suspending medical student clerkships due to COVID-19. Med Sci Educ. 2020;30(3):1-4. https://doi.org/10.1007/s40670-020-00994-1

References

1. McCaskill S. Sports tech comes of age with VR training, coaching apps and smart gear. Forbes. March 31, 2020. https://www.forbes.com/sites/stevemccaskill/2020/03/31/sports-tech-comes-of-age-with-vr-training-coaching-apps-and-smart-gear/?sh=309a8fa219c9
2. Carter K, Podczerwinski J, Love L, et al. Utilizing telesimulation for advanced skills training in consultation and handoff communication: a post-COVID-19 GME bootcamp experience. J Hosp Med. 2021;16(12)730-734. https://doi.org/10.12788/jhm.3733
3. Paige JT, Sonesh SC, Garbee DD, Bonanno LS. Comprensive Healthcare Simulation: Interprofessional Team Training and Simulation. 1st ed. Springer International Publishing; 2020. https://doi.org/10.1007/978-3-030-28845-7
4. Goldenberg MN, Hersh DC, Wilkins KM, Schwartz ML. Suspending medical student clerkships due to COVID-19. Med Sci Educ. 2020;30(3):1-4. https://doi.org/10.1007/s40670-020-00994-1

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