COVID-19 Impact on Veterans Health Administration Nurses: A Retrospective Survey

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COVID-19 Impact on Veterans Health Administration Nurses: A Retrospective Survey

On March 11, 2020, the World Health Organization designated COVID- 19 as a pandemic.1 Pandemics have historically impacted physical and mental health across all populations, but especially health care workers (HCWs).2 Nurses and other HCWs were profoundly impacted by the pandemic.3-8

Throughout the pandemic, nurses continued to provide care while working in short-staffed workplaces, facing increased exposure to COVID-19, and witnessing COVID—19–related morbidity and mortality.9 Many nurses were mandated to cross-train in unfamiliar clinical settings and adjust to new and prolonged shift schedules. Physical and emotional exhaustion associated with managing care for individuals with COVID-19, shortage of personal protective equipment (PPE), risk of infection, fear of secondary transmission to family members, feelings of being rejected by others, and social isolation, led to HCWs’ increased vulnerability to psychological impacts of the pandemic.8,10

A meta-analysis of 65 studies with > 79,000 participants found HCWs experienced significant levels of anxiety, depression, stress, insomnia, and other mental health issues, such as posttraumatic stress disorder (PTSD). Female HCWs, nurses, and frontline responders experienced a higher incidence of psychological impact.11 Other meta-analyses revealed that nurses’ compassion satisfaction, compassion fatigue, and burnout levels were significantly impacted with increased levels of burnout among nurses who had a friend or family member diagnosed with COVID- 19 or experienced prolonged threat of exposure to the virus.12,13 A study of 350 nurses found high rates of perceived transgressions by others, and betrayal.8 Nurse leaders and staff nurses had to persevere as moral distress became pervasive among nursing staff, which led to complex and often unsustainable circumstances. 14 The themes identified in the literature about the pandemic’s impact as well as witnessing nurse colleagues’ distress with patient mortality and death of coworkers during the early phase of the COVID-19 pandemic compelled a group of Veterans Health Administration (VHA) nurses to form a research team to understand the scope of impact and identify possible solutions.

Since published studies on the impact of pandemics on HCWs, including nurses, primarily focused on inpatient settings, the investigators of this study sought to capture the experiences of outpatient and inpatient nurses providing care in the US Department of Veterans Affairs (VA) Sierra Pacific Network (Veterans Integrated Service Network [VISN] 21), which has facilities in northern California, Hawaii, and Nevada.15-19 The purpose of this study was to identify the impact of COVID-19 on nurses caring for veterans in both outpatient and inpatient settings at VISN 21 facilities from March 2020 to September 2022, to inform leadership about the extent the virus affected nurses, and identify strategies that address current and future impacts of pandemics.

METHODS

This retrospective descriptive survey adapted the Pandemic Impact Survey by Purcell et al, which included the Moral Injury Events Scale, Primary Care PTSD Screener, the Patient Health Questionnaire-2 for depression, and a modified burnout scale.20-24 The survey of 70 Likert-scale questions was intended to measure nurses’ needs, burnout, moral distress, depression and stress symptoms, work-related factors, and intent to remain working in their current position. A nurse was defined broadly and included those employed as licensed vocational nurses (LVN), licensed practical nurses (LPN), registered nurses (RN), nurses with advanced degrees, advanced practice registered nurses (APRNs), and nurses with other certifications or licenses.

The VA Pacific Islands Research and Development Committee reviewed and approved the institutional review board-exempted study. The VISN 21 union was notified; only limited demographic information and broad VA tenure categories were collected to protect privacy. The principal investigator redacted facility identifier data after each facility had participated.

The survey was placed in REDCAP and a confidential link was emailed to all VISN 21 inpatient and outpatient nurses during March 2023. Because a comprehensive VISN 21 list of nurse email addresses was unavailable, the email was distributed by nursing leadership at each facility. Nurses received an email reminder at the 2-week halfway point, prompting them to complete the survey. The email indicated the purpose and voluntary nature of the study and cautioned nurses that they might experience stress while answering survey questions. Stress management resources were provided.

Descriptive statistics were used to report the results. Data were aggregated for analyzing and reporting purposes.

RESULTS

In March 2023, 860 of 5586 nurses (15%) responded to the survey. Respondents included 344 clinical inpatient nurses (40%) and 516 clinical outpatient nurses (60%); 688 (80%) were RNs, 129 (15%) were LPNs/LVNs, and 43 (5%) were APRNs. Of 849 respondents to provide their age, 15 (2%) were < 30 years, 163 (19%) were 30 to 39 years, 232 (27%) were 40 to 49 years, 259 (30%) were 50 to 59 years, and 180 (21%) were ≥ 60 years.

The survey found that 688 nurses reported job satisfaction (80%) and 75% of all respondents (66% among inpatient nurses) reported feeling happy with the care they delivered. Both inpatient and outpatient nurses indicated they could rely on staff. Sixty percent (n = 516) of the nurses indicated that facility management considered workplace health and safety and supervisors showed concern for subordinates, although inpatient nurses reported a lower percentage (Table 1).

FDP04203121_T1

Two hundred fifty-eight nurses (30%) reported having nurse colleagues who died and 52 (6%) had ≥ 3 colleagues who died. Among respondents, 292 had ≥ 3 patients who died after contracting COVID-19 and 232 (27%) had a significant person in their life die. More than one-half (54%; n = 464) of nurses had to limit contact with a family member who had COVID-19. Most nurses reported concerns about their colleagues (91%), were concerned about bringing COVID-19 home (82%), and stayed away from family during the pandemic (56%) (Table 2).

FDP04203121_T2

A total of 593 nurses (69%) reported feeling overwhelmed from the workload associated with the pandemic, 490 (57%) felt frustrated with role changes, 447 (52%) were stressed because of short staffing, and 327 (38%) felt stressed because of being assigned or floated to different patient care areas. Among inpatient nurses, 158 (46%) reported stress related to being floated. Coworker absenteeism caused challenges for 697 nurses (81%) (Table 3).

FDP04203121_T3

Nurses suggested a number of changes that could improve working conditions, including flexible scheduling (54%) and more hours of leave, which was requested by 43% of outpatient/inpatient nurses and 53% of inpatient alone nurses. Access to COVID-19 testing and PPE was endorsed as a workplace need by 439 nurses; the need for access to PPE was reported by 43% of inpatient-only nurses vs 29% of outpatient/inpatient nurses. The need for adequate staffing was reported by 54% of nurses although the rate was higher among those working inpatient settings (66%) (Table 4).

FDP04203121_T4

Four hundred sixty-four nurses (54%) felt tense and irritable at home because of work and 447 had ≥ 1 symptoms of burnout (Table 5). In terms of moral distress, > 30% of nurses witnessed morally incongruent situations, 10% felt their own moral code was violated, and > 30% felt betrayed by others (Table 6). Among respondents, 16% to 21% of nurses reported depressive symptoms (eAppendix). About 50% of nurses intended to stay in their current position while 20% indicated an intention to leave for another VA position.

FDP04203121_T5FDP04203121_T6FDP04203128_A1

DISCUSSION

This study identified the impact of COVID-19 on nurses who work in VISN 21. The survey included a significant number of nurses who work in outpatient settings, which differed from most other published studies to date.15-19 This study found that inpatient and outpatient nurses were similarly impacted by the COVID-19 pandemic, although there were differences. A high percentage of nurses reported job satisfaction despite the personal and professional impact of the pandemic.

Caring for veterans can result in a therapeutic relationship with a deep appreciation of veterans’ service and sensitivity to their needs.25 Some nurses reported that they feel it is a privilege to care for veterans.

Most nurses who participated in this study felt they could rely on their colleagues and were concerned about their health and wellbeing. Kissel et al explored protective factors for nurses during the pandemic and found participants often reported that their coworkers were positive safeguards.17 At least 50% of respondents reported that management considered workplace safety and was concerned about their welfare. Previous research has found that a positive working organization that promoted safety and concern for staff were protective factors against stress among HCWs.26 A literature review of 3 coronavirus outbreaks illustrated the support from supervisors and colleagues promoted resiliency and reduced stress disorders.3

Similar to other studies, study respondents experienced profound losses, including the deaths of colleagues, patients, and family. In 2021 Howell reported that HCWs experienced increased stress, fear, anxiety, and other negative emotions following news of colleagues’ deaths from COVID-19.27 Kissel et al reported that nurses frequently described pandemic-related physical and psychological harm and witnessing distress that they had not been previously exposed to.17

Our findings illustrate the tightrope nurses walked while caring for patients and concerns about the health of their colleagues and family. Consistent with our findings, Howell found that HCWs were afraid of contracting the infection at work and then unknowingly giving it to others such as patients, coworkers, and household members. 27 Murat et al reported that some nurses chose to live separately during the pandemic to avoid spreading COVID-19 to relatives.19 Several researchers found that concerns about family and children were prevalent and led to fear, anxiety, and burnout among nurses.18,28,29 Shah et al suggested that nurses experiencing death in the workplace and within their family may have resulted in fear and anxiety about returning to work.29 Garcia and Calvo argued that nurses may have been stigmatized as carriers of COVID-19.16 In addition, the loss of prepandemic workplace rituals may have impacted performance, team connection, and functioning, and led to increased turnover and decreased attachment to the organization.30

This study described the significant workplace issues nurses endured during the pandemic, including being overwhelmed with additional and/or multiple roles and frustrated and stressed with role changes and short staffing. Nurses endorsed workplace challenges in the context of coworker absenteeism and reassignments to different areas, such as intensive care units (ICUs).17 Researchers also reported that displaced team members experienced loneliness and isolation when they were removed from their usual place of work and experienced distress caring for patients beyond their perceived competency or comfort.17,31 Nurses also experienced rapid organizational changes, resource scarcity, high patient-to-nurse ratios, inconsistent or limited communications, and the absence of protocols for prolonged mass casualty events.17 These challenges, such as significant uncertainty and rapidly changing working conditions, were shared experiences suggested to be similar to “tumbling into chaos,” and likened to the overwhelming situations faced during patient surges to a medical “war zone.”17

Study respondents indicated that nurses wanted better access to critical supplies, PPE, and COVID-19 testing; more flexible scheduling; longer leave times; and staffing that was appropriate to the patient volumes. These findings aligned with previous research. Howell found that HCWs, especially nurses, worried about childcare because of school closures and increased work hours.27 Nurses felt that hospital support was inaccessible or inadequate and worried about access to essential resources.17-19,27 Studies also found excessive workloads, and many nurses needed mental or financial assistance from the hospital in addition to more rest and less work.18,28 An editorial highlighted the potential adverse effects that a lack of PPE could have on staff ’s mental health because of perceptions of institutional betrayal, which occurs when trusted and powerful organizations seemingly act in ways that can harm those dependent on them for safety and well-being.32

Consistent with other research, this study found that a majority of nurses experienced significant burnout symptoms. The number of nurses reporting symptoms of burnout increased during the pandemic with ICU nurses reporting the highest levels.17,33 Soto-Rubio et al emphasized that working conditions experienced by nurses, such as interpersonal conflict, lack of trust in administration, workload, and role conflict, contributed to burnout during COVID-19.34 Other studies found that nurses experienced burnout caused by uncertainty, intense work, and extra duties contributed to higher burnout scores.18,19 It is not surprising that researchers have indicated that nurses experiencing burnout might display depressive and stress-related symptoms, insomnia, and concentration and memory problems.19

The results of this study indicate that one-third of participating nurses were experiencing moral distress. Burton et al described COVID-19 as an environment in which nurses witnessed, experienced, and at times had to participate in acts that involved ethical violations in care, institutional betrayal, and traumatic strain.9 Of note, our findings revealed that both inpatient and outpatient nurses experienced moral distress. Interestingly, Mantri et al found that COVID-19 increased moral injury but not burnout among health professionals, which differed from the results of this study.35

The findings of this study indicate that many nurses experienced depressive symptoms. A systematic review found a similar percentage of HCWs experienced depression while caring for patients with COVID- 19, though a Chinese study found a higher percentage.36,37 Previous research also found that the most difficult aspect of the COVID- 19 pandemic for nurses was coping with mental disorders such as depression, and that many experienced difficulty sleeping/ had poor sleep quality, believed a similar disaster would occur in the future, were irritated or angered easily, and experienced emotional exhaustion.15,19 The long-term mental and physical ramifications of caring for individuals with COVID-19 remain unknown. However, previous research suggests a high prevalence of depression, insomnia, anxiety, and distress, which could impair nurses’ professional performance.29

This study reported that a majority of nurses intended to stay in their current position and about 20% intended to leave for another position within the VA. Similar findings conducted early in the pandemic indicated that most participants did not intend to quit nursing.19

This study’s findings suggest the COVID-19 pandemic had an adverse impact on VISN 21 nurses. It is critical to develop, implement, and adopt adequate measures as early as possible to support the health care system, especially nurses.18

Implications

Before the COVID-19 pandemic, discussing burnout and moral anguish was common, primarily in critical care.14 However, these experiences became more widespread throughout nursing settings during the pandemic. Nurse leaders have been identified as responsible for ensuring the environmental safety and personal well-being of their colleagues during and after pandemics.14

Studies of HCW experiences during COVID-19 provide many insights into future preparedness, strategies to best handle another pandemic during its acute stage, and techniques to address issues that might persist. This study and others suggest that comprehensive interventions in preparation for, during, and after a pandemic are needed. We break down strategies into pandemic and postpandemic interventions based on a synthesis of the literature and the research team’s knowledge and expertise.3,14-16,27,29,36,38-44

Pandemic interventions. During a pandemic, it is important that nurses are adequately cared for to ensure they can continue to provide quality care for others. Resources supporting emotional well-being and addressing moral distress offered during a pandemic are essential. Implementing meaningful strategies could enhance nurses’ health and wellbeing. It is essential that leaders provide nurses a safe work environment/experience during a pandemic by instituting meaningful resources. In addition, developing best practices for leadership are critical.

Postpandemic interventions. Personal experiences of depression, burnout, and moral distress have not spontaneously resolved as the pandemic receded. Providing postpandemic interventions to lessen ongoing and lingering depressive, burnout, and moral distress symptoms experienced by frontline workers are critical. These interventions might prevent long-term health issues and the exodus of nurses.

Postpandemic interventions should include the integration of pandemic planning into new or existing educational or training programs for staff. Promotion and support of mental health services by health system leadership for nursing personnel implemented as a usual service will play an important role in preparing for future pandemics. A key role in preparation is developing and maintaining cooperation and ongoing mutual understanding, respect, and communication between leadership and nursing staff.

Future Research

This study’s findings inform VHA leadership and society about how a large group of nurses were impacted by COVID-19 while caring for patients in inpatient and outpatient settings and could provide a basis for extending this research to other groups of nurses or health care personnel. Future research might be helpful in identifying the impact of COVID-19 on nursing leadership. During conversations with nursing leadership, a common theme identified was that nurses did not feel that leadership was fully prepared for the level of emergency the pandemic created both personally and professionally; leadership expressed experiences similar to nurses providing direct care and felt powerless to help their nursing staff. Other areas of research could include identifying underlying factors contributing to burnout and moral distress and describing nurses’ expectations of or needs from leadership to best manage burnout and moral distress.

Limitations

Experiences of nurses who stopped working were not captured and information about their experiences might have different results. The survey distribution was limited to 2 emails (an initial email and a second at midpoint) sent at the discretion of the nurse executive of each facility. The study timeline was long because of complex regulatory protective processes inherent in the VHA system for researchers to include initial institutional review board review process, union notifications, and each facility’s response to the survey. Although 860 nurses participated, this was 15% of the 5586 VISN 21 nurses at the time of the study. Many clinical inpatient nurses do not have regular access to email, which might have impacted participation rate.

CONCLUSIONS

This study identified the impact COVID-19 had on nurses who worked in a large hospital system. The research team outlined strategies to be employed during and after the pandemic, such as preplanning for future pandemics to provide a framework for a comprehensive pandemic response protocol.

This study adds to generalized knowledge because it captured voices of inpatient and outpatient nurses, the latter had not been previously studied. As nurses and health care organizations move beyond the pandemic with a significant number of nurses continuing to experience effects, there is a need to institute interventions to assist nurses in healing and begin preparations for future pandemics.

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Judy Carlson, EdD, MSN, APRN, BCNa; Tymeeka Davis, DNP, RN-BC, PCCN, CNLb; Tracie Citron, MS, APRN, AGAC-NP, ACNS-BCc; Amalia Garcia, BSN, RN, CCMc; Kelly Presser, MSN, RN, CNLd; Saida Adem, MSN, APRNc; Arlene Perry, MSEd, MS, RN, CMCN, IQCIb; Anna Farrell, MSN, RN, CMGT-BCe; Shakalee Exantus, MSN, RNb; Brandy Mebane, BSN, RNb; Kasey Redding, MSN, RN, CPNa; Natalie Purcell, PhDf

Author affiliations
aVeterans Affairs Pacific Islands Health Care System, Honolulu, Hawaii
bVeterans Affairs Southern Nevada Healthcare System, Las Vegas
cVeterans Affairs San Francisco Health Care System, California
dVeterans Affairs Sierra Nevada Health Care System, Reno
eVeterans Affairs Northern California Health Care System, Sacramento
fVeterans Affairs Palo Alto Health Care System, California

Author disclosures The authors report no actual or potential conflicts of interest regarding this article.

Correspondence: Judy Carlson ([email protected])

Fed Pract. 2025;42(3). Published online March 17. doi:10.12788/fp.0555

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Judy Carlson, EdD, MSN, APRN, BCNa; Tymeeka Davis, DNP, RN-BC, PCCN, CNLb; Tracie Citron, MS, APRN, AGAC-NP, ACNS-BCc; Amalia Garcia, BSN, RN, CCMc; Kelly Presser, MSN, RN, CNLd; Saida Adem, MSN, APRNc; Arlene Perry, MSEd, MS, RN, CMCN, IQCIb; Anna Farrell, MSN, RN, CMGT-BCe; Shakalee Exantus, MSN, RNb; Brandy Mebane, BSN, RNb; Kasey Redding, MSN, RN, CPNa; Natalie Purcell, PhDf

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aVeterans Affairs Pacific Islands Health Care System, Honolulu, Hawaii
bVeterans Affairs Southern Nevada Healthcare System, Las Vegas
cVeterans Affairs San Francisco Health Care System, California
dVeterans Affairs Sierra Nevada Health Care System, Reno
eVeterans Affairs Northern California Health Care System, Sacramento
fVeterans Affairs Palo Alto Health Care System, California

Author disclosures The authors report no actual or potential conflicts of interest regarding this article.

Correspondence: Judy Carlson ([email protected])

Fed Pract. 2025;42(3). Published online March 17. doi:10.12788/fp.0555

Author and Disclosure Information

Judy Carlson, EdD, MSN, APRN, BCNa; Tymeeka Davis, DNP, RN-BC, PCCN, CNLb; Tracie Citron, MS, APRN, AGAC-NP, ACNS-BCc; Amalia Garcia, BSN, RN, CCMc; Kelly Presser, MSN, RN, CNLd; Saida Adem, MSN, APRNc; Arlene Perry, MSEd, MS, RN, CMCN, IQCIb; Anna Farrell, MSN, RN, CMGT-BCe; Shakalee Exantus, MSN, RNb; Brandy Mebane, BSN, RNb; Kasey Redding, MSN, RN, CPNa; Natalie Purcell, PhDf

Author affiliations
aVeterans Affairs Pacific Islands Health Care System, Honolulu, Hawaii
bVeterans Affairs Southern Nevada Healthcare System, Las Vegas
cVeterans Affairs San Francisco Health Care System, California
dVeterans Affairs Sierra Nevada Health Care System, Reno
eVeterans Affairs Northern California Health Care System, Sacramento
fVeterans Affairs Palo Alto Health Care System, California

Author disclosures The authors report no actual or potential conflicts of interest regarding this article.

Correspondence: Judy Carlson ([email protected])

Fed Pract. 2025;42(3). Published online March 17. doi:10.12788/fp.0555

Article PDF
Article PDF

On March 11, 2020, the World Health Organization designated COVID- 19 as a pandemic.1 Pandemics have historically impacted physical and mental health across all populations, but especially health care workers (HCWs).2 Nurses and other HCWs were profoundly impacted by the pandemic.3-8

Throughout the pandemic, nurses continued to provide care while working in short-staffed workplaces, facing increased exposure to COVID-19, and witnessing COVID—19–related morbidity and mortality.9 Many nurses were mandated to cross-train in unfamiliar clinical settings and adjust to new and prolonged shift schedules. Physical and emotional exhaustion associated with managing care for individuals with COVID-19, shortage of personal protective equipment (PPE), risk of infection, fear of secondary transmission to family members, feelings of being rejected by others, and social isolation, led to HCWs’ increased vulnerability to psychological impacts of the pandemic.8,10

A meta-analysis of 65 studies with > 79,000 participants found HCWs experienced significant levels of anxiety, depression, stress, insomnia, and other mental health issues, such as posttraumatic stress disorder (PTSD). Female HCWs, nurses, and frontline responders experienced a higher incidence of psychological impact.11 Other meta-analyses revealed that nurses’ compassion satisfaction, compassion fatigue, and burnout levels were significantly impacted with increased levels of burnout among nurses who had a friend or family member diagnosed with COVID- 19 or experienced prolonged threat of exposure to the virus.12,13 A study of 350 nurses found high rates of perceived transgressions by others, and betrayal.8 Nurse leaders and staff nurses had to persevere as moral distress became pervasive among nursing staff, which led to complex and often unsustainable circumstances. 14 The themes identified in the literature about the pandemic’s impact as well as witnessing nurse colleagues’ distress with patient mortality and death of coworkers during the early phase of the COVID-19 pandemic compelled a group of Veterans Health Administration (VHA) nurses to form a research team to understand the scope of impact and identify possible solutions.

Since published studies on the impact of pandemics on HCWs, including nurses, primarily focused on inpatient settings, the investigators of this study sought to capture the experiences of outpatient and inpatient nurses providing care in the US Department of Veterans Affairs (VA) Sierra Pacific Network (Veterans Integrated Service Network [VISN] 21), which has facilities in northern California, Hawaii, and Nevada.15-19 The purpose of this study was to identify the impact of COVID-19 on nurses caring for veterans in both outpatient and inpatient settings at VISN 21 facilities from March 2020 to September 2022, to inform leadership about the extent the virus affected nurses, and identify strategies that address current and future impacts of pandemics.

METHODS

This retrospective descriptive survey adapted the Pandemic Impact Survey by Purcell et al, which included the Moral Injury Events Scale, Primary Care PTSD Screener, the Patient Health Questionnaire-2 for depression, and a modified burnout scale.20-24 The survey of 70 Likert-scale questions was intended to measure nurses’ needs, burnout, moral distress, depression and stress symptoms, work-related factors, and intent to remain working in their current position. A nurse was defined broadly and included those employed as licensed vocational nurses (LVN), licensed practical nurses (LPN), registered nurses (RN), nurses with advanced degrees, advanced practice registered nurses (APRNs), and nurses with other certifications or licenses.

The VA Pacific Islands Research and Development Committee reviewed and approved the institutional review board-exempted study. The VISN 21 union was notified; only limited demographic information and broad VA tenure categories were collected to protect privacy. The principal investigator redacted facility identifier data after each facility had participated.

The survey was placed in REDCAP and a confidential link was emailed to all VISN 21 inpatient and outpatient nurses during March 2023. Because a comprehensive VISN 21 list of nurse email addresses was unavailable, the email was distributed by nursing leadership at each facility. Nurses received an email reminder at the 2-week halfway point, prompting them to complete the survey. The email indicated the purpose and voluntary nature of the study and cautioned nurses that they might experience stress while answering survey questions. Stress management resources were provided.

Descriptive statistics were used to report the results. Data were aggregated for analyzing and reporting purposes.

RESULTS

In March 2023, 860 of 5586 nurses (15%) responded to the survey. Respondents included 344 clinical inpatient nurses (40%) and 516 clinical outpatient nurses (60%); 688 (80%) were RNs, 129 (15%) were LPNs/LVNs, and 43 (5%) were APRNs. Of 849 respondents to provide their age, 15 (2%) were < 30 years, 163 (19%) were 30 to 39 years, 232 (27%) were 40 to 49 years, 259 (30%) were 50 to 59 years, and 180 (21%) were ≥ 60 years.

The survey found that 688 nurses reported job satisfaction (80%) and 75% of all respondents (66% among inpatient nurses) reported feeling happy with the care they delivered. Both inpatient and outpatient nurses indicated they could rely on staff. Sixty percent (n = 516) of the nurses indicated that facility management considered workplace health and safety and supervisors showed concern for subordinates, although inpatient nurses reported a lower percentage (Table 1).

FDP04203121_T1

Two hundred fifty-eight nurses (30%) reported having nurse colleagues who died and 52 (6%) had ≥ 3 colleagues who died. Among respondents, 292 had ≥ 3 patients who died after contracting COVID-19 and 232 (27%) had a significant person in their life die. More than one-half (54%; n = 464) of nurses had to limit contact with a family member who had COVID-19. Most nurses reported concerns about their colleagues (91%), were concerned about bringing COVID-19 home (82%), and stayed away from family during the pandemic (56%) (Table 2).

FDP04203121_T2

A total of 593 nurses (69%) reported feeling overwhelmed from the workload associated with the pandemic, 490 (57%) felt frustrated with role changes, 447 (52%) were stressed because of short staffing, and 327 (38%) felt stressed because of being assigned or floated to different patient care areas. Among inpatient nurses, 158 (46%) reported stress related to being floated. Coworker absenteeism caused challenges for 697 nurses (81%) (Table 3).

FDP04203121_T3

Nurses suggested a number of changes that could improve working conditions, including flexible scheduling (54%) and more hours of leave, which was requested by 43% of outpatient/inpatient nurses and 53% of inpatient alone nurses. Access to COVID-19 testing and PPE was endorsed as a workplace need by 439 nurses; the need for access to PPE was reported by 43% of inpatient-only nurses vs 29% of outpatient/inpatient nurses. The need for adequate staffing was reported by 54% of nurses although the rate was higher among those working inpatient settings (66%) (Table 4).

FDP04203121_T4

Four hundred sixty-four nurses (54%) felt tense and irritable at home because of work and 447 had ≥ 1 symptoms of burnout (Table 5). In terms of moral distress, > 30% of nurses witnessed morally incongruent situations, 10% felt their own moral code was violated, and > 30% felt betrayed by others (Table 6). Among respondents, 16% to 21% of nurses reported depressive symptoms (eAppendix). About 50% of nurses intended to stay in their current position while 20% indicated an intention to leave for another VA position.

FDP04203121_T5FDP04203121_T6FDP04203128_A1

DISCUSSION

This study identified the impact of COVID-19 on nurses who work in VISN 21. The survey included a significant number of nurses who work in outpatient settings, which differed from most other published studies to date.15-19 This study found that inpatient and outpatient nurses were similarly impacted by the COVID-19 pandemic, although there were differences. A high percentage of nurses reported job satisfaction despite the personal and professional impact of the pandemic.

Caring for veterans can result in a therapeutic relationship with a deep appreciation of veterans’ service and sensitivity to their needs.25 Some nurses reported that they feel it is a privilege to care for veterans.

Most nurses who participated in this study felt they could rely on their colleagues and were concerned about their health and wellbeing. Kissel et al explored protective factors for nurses during the pandemic and found participants often reported that their coworkers were positive safeguards.17 At least 50% of respondents reported that management considered workplace safety and was concerned about their welfare. Previous research has found that a positive working organization that promoted safety and concern for staff were protective factors against stress among HCWs.26 A literature review of 3 coronavirus outbreaks illustrated the support from supervisors and colleagues promoted resiliency and reduced stress disorders.3

Similar to other studies, study respondents experienced profound losses, including the deaths of colleagues, patients, and family. In 2021 Howell reported that HCWs experienced increased stress, fear, anxiety, and other negative emotions following news of colleagues’ deaths from COVID-19.27 Kissel et al reported that nurses frequently described pandemic-related physical and psychological harm and witnessing distress that they had not been previously exposed to.17

Our findings illustrate the tightrope nurses walked while caring for patients and concerns about the health of their colleagues and family. Consistent with our findings, Howell found that HCWs were afraid of contracting the infection at work and then unknowingly giving it to others such as patients, coworkers, and household members. 27 Murat et al reported that some nurses chose to live separately during the pandemic to avoid spreading COVID-19 to relatives.19 Several researchers found that concerns about family and children were prevalent and led to fear, anxiety, and burnout among nurses.18,28,29 Shah et al suggested that nurses experiencing death in the workplace and within their family may have resulted in fear and anxiety about returning to work.29 Garcia and Calvo argued that nurses may have been stigmatized as carriers of COVID-19.16 In addition, the loss of prepandemic workplace rituals may have impacted performance, team connection, and functioning, and led to increased turnover and decreased attachment to the organization.30

This study described the significant workplace issues nurses endured during the pandemic, including being overwhelmed with additional and/or multiple roles and frustrated and stressed with role changes and short staffing. Nurses endorsed workplace challenges in the context of coworker absenteeism and reassignments to different areas, such as intensive care units (ICUs).17 Researchers also reported that displaced team members experienced loneliness and isolation when they were removed from their usual place of work and experienced distress caring for patients beyond their perceived competency or comfort.17,31 Nurses also experienced rapid organizational changes, resource scarcity, high patient-to-nurse ratios, inconsistent or limited communications, and the absence of protocols for prolonged mass casualty events.17 These challenges, such as significant uncertainty and rapidly changing working conditions, were shared experiences suggested to be similar to “tumbling into chaos,” and likened to the overwhelming situations faced during patient surges to a medical “war zone.”17

Study respondents indicated that nurses wanted better access to critical supplies, PPE, and COVID-19 testing; more flexible scheduling; longer leave times; and staffing that was appropriate to the patient volumes. These findings aligned with previous research. Howell found that HCWs, especially nurses, worried about childcare because of school closures and increased work hours.27 Nurses felt that hospital support was inaccessible or inadequate and worried about access to essential resources.17-19,27 Studies also found excessive workloads, and many nurses needed mental or financial assistance from the hospital in addition to more rest and less work.18,28 An editorial highlighted the potential adverse effects that a lack of PPE could have on staff ’s mental health because of perceptions of institutional betrayal, which occurs when trusted and powerful organizations seemingly act in ways that can harm those dependent on them for safety and well-being.32

Consistent with other research, this study found that a majority of nurses experienced significant burnout symptoms. The number of nurses reporting symptoms of burnout increased during the pandemic with ICU nurses reporting the highest levels.17,33 Soto-Rubio et al emphasized that working conditions experienced by nurses, such as interpersonal conflict, lack of trust in administration, workload, and role conflict, contributed to burnout during COVID-19.34 Other studies found that nurses experienced burnout caused by uncertainty, intense work, and extra duties contributed to higher burnout scores.18,19 It is not surprising that researchers have indicated that nurses experiencing burnout might display depressive and stress-related symptoms, insomnia, and concentration and memory problems.19

The results of this study indicate that one-third of participating nurses were experiencing moral distress. Burton et al described COVID-19 as an environment in which nurses witnessed, experienced, and at times had to participate in acts that involved ethical violations in care, institutional betrayal, and traumatic strain.9 Of note, our findings revealed that both inpatient and outpatient nurses experienced moral distress. Interestingly, Mantri et al found that COVID-19 increased moral injury but not burnout among health professionals, which differed from the results of this study.35

The findings of this study indicate that many nurses experienced depressive symptoms. A systematic review found a similar percentage of HCWs experienced depression while caring for patients with COVID- 19, though a Chinese study found a higher percentage.36,37 Previous research also found that the most difficult aspect of the COVID- 19 pandemic for nurses was coping with mental disorders such as depression, and that many experienced difficulty sleeping/ had poor sleep quality, believed a similar disaster would occur in the future, were irritated or angered easily, and experienced emotional exhaustion.15,19 The long-term mental and physical ramifications of caring for individuals with COVID-19 remain unknown. However, previous research suggests a high prevalence of depression, insomnia, anxiety, and distress, which could impair nurses’ professional performance.29

This study reported that a majority of nurses intended to stay in their current position and about 20% intended to leave for another position within the VA. Similar findings conducted early in the pandemic indicated that most participants did not intend to quit nursing.19

This study’s findings suggest the COVID-19 pandemic had an adverse impact on VISN 21 nurses. It is critical to develop, implement, and adopt adequate measures as early as possible to support the health care system, especially nurses.18

Implications

Before the COVID-19 pandemic, discussing burnout and moral anguish was common, primarily in critical care.14 However, these experiences became more widespread throughout nursing settings during the pandemic. Nurse leaders have been identified as responsible for ensuring the environmental safety and personal well-being of their colleagues during and after pandemics.14

Studies of HCW experiences during COVID-19 provide many insights into future preparedness, strategies to best handle another pandemic during its acute stage, and techniques to address issues that might persist. This study and others suggest that comprehensive interventions in preparation for, during, and after a pandemic are needed. We break down strategies into pandemic and postpandemic interventions based on a synthesis of the literature and the research team’s knowledge and expertise.3,14-16,27,29,36,38-44

Pandemic interventions. During a pandemic, it is important that nurses are adequately cared for to ensure they can continue to provide quality care for others. Resources supporting emotional well-being and addressing moral distress offered during a pandemic are essential. Implementing meaningful strategies could enhance nurses’ health and wellbeing. It is essential that leaders provide nurses a safe work environment/experience during a pandemic by instituting meaningful resources. In addition, developing best practices for leadership are critical.

Postpandemic interventions. Personal experiences of depression, burnout, and moral distress have not spontaneously resolved as the pandemic receded. Providing postpandemic interventions to lessen ongoing and lingering depressive, burnout, and moral distress symptoms experienced by frontline workers are critical. These interventions might prevent long-term health issues and the exodus of nurses.

Postpandemic interventions should include the integration of pandemic planning into new or existing educational or training programs for staff. Promotion and support of mental health services by health system leadership for nursing personnel implemented as a usual service will play an important role in preparing for future pandemics. A key role in preparation is developing and maintaining cooperation and ongoing mutual understanding, respect, and communication between leadership and nursing staff.

Future Research

This study’s findings inform VHA leadership and society about how a large group of nurses were impacted by COVID-19 while caring for patients in inpatient and outpatient settings and could provide a basis for extending this research to other groups of nurses or health care personnel. Future research might be helpful in identifying the impact of COVID-19 on nursing leadership. During conversations with nursing leadership, a common theme identified was that nurses did not feel that leadership was fully prepared for the level of emergency the pandemic created both personally and professionally; leadership expressed experiences similar to nurses providing direct care and felt powerless to help their nursing staff. Other areas of research could include identifying underlying factors contributing to burnout and moral distress and describing nurses’ expectations of or needs from leadership to best manage burnout and moral distress.

Limitations

Experiences of nurses who stopped working were not captured and information about their experiences might have different results. The survey distribution was limited to 2 emails (an initial email and a second at midpoint) sent at the discretion of the nurse executive of each facility. The study timeline was long because of complex regulatory protective processes inherent in the VHA system for researchers to include initial institutional review board review process, union notifications, and each facility’s response to the survey. Although 860 nurses participated, this was 15% of the 5586 VISN 21 nurses at the time of the study. Many clinical inpatient nurses do not have regular access to email, which might have impacted participation rate.

CONCLUSIONS

This study identified the impact COVID-19 had on nurses who worked in a large hospital system. The research team outlined strategies to be employed during and after the pandemic, such as preplanning for future pandemics to provide a framework for a comprehensive pandemic response protocol.

This study adds to generalized knowledge because it captured voices of inpatient and outpatient nurses, the latter had not been previously studied. As nurses and health care organizations move beyond the pandemic with a significant number of nurses continuing to experience effects, there is a need to institute interventions to assist nurses in healing and begin preparations for future pandemics.

On March 11, 2020, the World Health Organization designated COVID- 19 as a pandemic.1 Pandemics have historically impacted physical and mental health across all populations, but especially health care workers (HCWs).2 Nurses and other HCWs were profoundly impacted by the pandemic.3-8

Throughout the pandemic, nurses continued to provide care while working in short-staffed workplaces, facing increased exposure to COVID-19, and witnessing COVID—19–related morbidity and mortality.9 Many nurses were mandated to cross-train in unfamiliar clinical settings and adjust to new and prolonged shift schedules. Physical and emotional exhaustion associated with managing care for individuals with COVID-19, shortage of personal protective equipment (PPE), risk of infection, fear of secondary transmission to family members, feelings of being rejected by others, and social isolation, led to HCWs’ increased vulnerability to psychological impacts of the pandemic.8,10

A meta-analysis of 65 studies with > 79,000 participants found HCWs experienced significant levels of anxiety, depression, stress, insomnia, and other mental health issues, such as posttraumatic stress disorder (PTSD). Female HCWs, nurses, and frontline responders experienced a higher incidence of psychological impact.11 Other meta-analyses revealed that nurses’ compassion satisfaction, compassion fatigue, and burnout levels were significantly impacted with increased levels of burnout among nurses who had a friend or family member diagnosed with COVID- 19 or experienced prolonged threat of exposure to the virus.12,13 A study of 350 nurses found high rates of perceived transgressions by others, and betrayal.8 Nurse leaders and staff nurses had to persevere as moral distress became pervasive among nursing staff, which led to complex and often unsustainable circumstances. 14 The themes identified in the literature about the pandemic’s impact as well as witnessing nurse colleagues’ distress with patient mortality and death of coworkers during the early phase of the COVID-19 pandemic compelled a group of Veterans Health Administration (VHA) nurses to form a research team to understand the scope of impact and identify possible solutions.

Since published studies on the impact of pandemics on HCWs, including nurses, primarily focused on inpatient settings, the investigators of this study sought to capture the experiences of outpatient and inpatient nurses providing care in the US Department of Veterans Affairs (VA) Sierra Pacific Network (Veterans Integrated Service Network [VISN] 21), which has facilities in northern California, Hawaii, and Nevada.15-19 The purpose of this study was to identify the impact of COVID-19 on nurses caring for veterans in both outpatient and inpatient settings at VISN 21 facilities from March 2020 to September 2022, to inform leadership about the extent the virus affected nurses, and identify strategies that address current and future impacts of pandemics.

METHODS

This retrospective descriptive survey adapted the Pandemic Impact Survey by Purcell et al, which included the Moral Injury Events Scale, Primary Care PTSD Screener, the Patient Health Questionnaire-2 for depression, and a modified burnout scale.20-24 The survey of 70 Likert-scale questions was intended to measure nurses’ needs, burnout, moral distress, depression and stress symptoms, work-related factors, and intent to remain working in their current position. A nurse was defined broadly and included those employed as licensed vocational nurses (LVN), licensed practical nurses (LPN), registered nurses (RN), nurses with advanced degrees, advanced practice registered nurses (APRNs), and nurses with other certifications or licenses.

The VA Pacific Islands Research and Development Committee reviewed and approved the institutional review board-exempted study. The VISN 21 union was notified; only limited demographic information and broad VA tenure categories were collected to protect privacy. The principal investigator redacted facility identifier data after each facility had participated.

The survey was placed in REDCAP and a confidential link was emailed to all VISN 21 inpatient and outpatient nurses during March 2023. Because a comprehensive VISN 21 list of nurse email addresses was unavailable, the email was distributed by nursing leadership at each facility. Nurses received an email reminder at the 2-week halfway point, prompting them to complete the survey. The email indicated the purpose and voluntary nature of the study and cautioned nurses that they might experience stress while answering survey questions. Stress management resources were provided.

Descriptive statistics were used to report the results. Data were aggregated for analyzing and reporting purposes.

RESULTS

In March 2023, 860 of 5586 nurses (15%) responded to the survey. Respondents included 344 clinical inpatient nurses (40%) and 516 clinical outpatient nurses (60%); 688 (80%) were RNs, 129 (15%) were LPNs/LVNs, and 43 (5%) were APRNs. Of 849 respondents to provide their age, 15 (2%) were < 30 years, 163 (19%) were 30 to 39 years, 232 (27%) were 40 to 49 years, 259 (30%) were 50 to 59 years, and 180 (21%) were ≥ 60 years.

The survey found that 688 nurses reported job satisfaction (80%) and 75% of all respondents (66% among inpatient nurses) reported feeling happy with the care they delivered. Both inpatient and outpatient nurses indicated they could rely on staff. Sixty percent (n = 516) of the nurses indicated that facility management considered workplace health and safety and supervisors showed concern for subordinates, although inpatient nurses reported a lower percentage (Table 1).

FDP04203121_T1

Two hundred fifty-eight nurses (30%) reported having nurse colleagues who died and 52 (6%) had ≥ 3 colleagues who died. Among respondents, 292 had ≥ 3 patients who died after contracting COVID-19 and 232 (27%) had a significant person in their life die. More than one-half (54%; n = 464) of nurses had to limit contact with a family member who had COVID-19. Most nurses reported concerns about their colleagues (91%), were concerned about bringing COVID-19 home (82%), and stayed away from family during the pandemic (56%) (Table 2).

FDP04203121_T2

A total of 593 nurses (69%) reported feeling overwhelmed from the workload associated with the pandemic, 490 (57%) felt frustrated with role changes, 447 (52%) were stressed because of short staffing, and 327 (38%) felt stressed because of being assigned or floated to different patient care areas. Among inpatient nurses, 158 (46%) reported stress related to being floated. Coworker absenteeism caused challenges for 697 nurses (81%) (Table 3).

FDP04203121_T3

Nurses suggested a number of changes that could improve working conditions, including flexible scheduling (54%) and more hours of leave, which was requested by 43% of outpatient/inpatient nurses and 53% of inpatient alone nurses. Access to COVID-19 testing and PPE was endorsed as a workplace need by 439 nurses; the need for access to PPE was reported by 43% of inpatient-only nurses vs 29% of outpatient/inpatient nurses. The need for adequate staffing was reported by 54% of nurses although the rate was higher among those working inpatient settings (66%) (Table 4).

FDP04203121_T4

Four hundred sixty-four nurses (54%) felt tense and irritable at home because of work and 447 had ≥ 1 symptoms of burnout (Table 5). In terms of moral distress, > 30% of nurses witnessed morally incongruent situations, 10% felt their own moral code was violated, and > 30% felt betrayed by others (Table 6). Among respondents, 16% to 21% of nurses reported depressive symptoms (eAppendix). About 50% of nurses intended to stay in their current position while 20% indicated an intention to leave for another VA position.

FDP04203121_T5FDP04203121_T6FDP04203128_A1

DISCUSSION

This study identified the impact of COVID-19 on nurses who work in VISN 21. The survey included a significant number of nurses who work in outpatient settings, which differed from most other published studies to date.15-19 This study found that inpatient and outpatient nurses were similarly impacted by the COVID-19 pandemic, although there were differences. A high percentage of nurses reported job satisfaction despite the personal and professional impact of the pandemic.

Caring for veterans can result in a therapeutic relationship with a deep appreciation of veterans’ service and sensitivity to their needs.25 Some nurses reported that they feel it is a privilege to care for veterans.

Most nurses who participated in this study felt they could rely on their colleagues and were concerned about their health and wellbeing. Kissel et al explored protective factors for nurses during the pandemic and found participants often reported that their coworkers were positive safeguards.17 At least 50% of respondents reported that management considered workplace safety and was concerned about their welfare. Previous research has found that a positive working organization that promoted safety and concern for staff were protective factors against stress among HCWs.26 A literature review of 3 coronavirus outbreaks illustrated the support from supervisors and colleagues promoted resiliency and reduced stress disorders.3

Similar to other studies, study respondents experienced profound losses, including the deaths of colleagues, patients, and family. In 2021 Howell reported that HCWs experienced increased stress, fear, anxiety, and other negative emotions following news of colleagues’ deaths from COVID-19.27 Kissel et al reported that nurses frequently described pandemic-related physical and psychological harm and witnessing distress that they had not been previously exposed to.17

Our findings illustrate the tightrope nurses walked while caring for patients and concerns about the health of their colleagues and family. Consistent with our findings, Howell found that HCWs were afraid of contracting the infection at work and then unknowingly giving it to others such as patients, coworkers, and household members. 27 Murat et al reported that some nurses chose to live separately during the pandemic to avoid spreading COVID-19 to relatives.19 Several researchers found that concerns about family and children were prevalent and led to fear, anxiety, and burnout among nurses.18,28,29 Shah et al suggested that nurses experiencing death in the workplace and within their family may have resulted in fear and anxiety about returning to work.29 Garcia and Calvo argued that nurses may have been stigmatized as carriers of COVID-19.16 In addition, the loss of prepandemic workplace rituals may have impacted performance, team connection, and functioning, and led to increased turnover and decreased attachment to the organization.30

This study described the significant workplace issues nurses endured during the pandemic, including being overwhelmed with additional and/or multiple roles and frustrated and stressed with role changes and short staffing. Nurses endorsed workplace challenges in the context of coworker absenteeism and reassignments to different areas, such as intensive care units (ICUs).17 Researchers also reported that displaced team members experienced loneliness and isolation when they were removed from their usual place of work and experienced distress caring for patients beyond their perceived competency or comfort.17,31 Nurses also experienced rapid organizational changes, resource scarcity, high patient-to-nurse ratios, inconsistent or limited communications, and the absence of protocols for prolonged mass casualty events.17 These challenges, such as significant uncertainty and rapidly changing working conditions, were shared experiences suggested to be similar to “tumbling into chaos,” and likened to the overwhelming situations faced during patient surges to a medical “war zone.”17

Study respondents indicated that nurses wanted better access to critical supplies, PPE, and COVID-19 testing; more flexible scheduling; longer leave times; and staffing that was appropriate to the patient volumes. These findings aligned with previous research. Howell found that HCWs, especially nurses, worried about childcare because of school closures and increased work hours.27 Nurses felt that hospital support was inaccessible or inadequate and worried about access to essential resources.17-19,27 Studies also found excessive workloads, and many nurses needed mental or financial assistance from the hospital in addition to more rest and less work.18,28 An editorial highlighted the potential adverse effects that a lack of PPE could have on staff ’s mental health because of perceptions of institutional betrayal, which occurs when trusted and powerful organizations seemingly act in ways that can harm those dependent on them for safety and well-being.32

Consistent with other research, this study found that a majority of nurses experienced significant burnout symptoms. The number of nurses reporting symptoms of burnout increased during the pandemic with ICU nurses reporting the highest levels.17,33 Soto-Rubio et al emphasized that working conditions experienced by nurses, such as interpersonal conflict, lack of trust in administration, workload, and role conflict, contributed to burnout during COVID-19.34 Other studies found that nurses experienced burnout caused by uncertainty, intense work, and extra duties contributed to higher burnout scores.18,19 It is not surprising that researchers have indicated that nurses experiencing burnout might display depressive and stress-related symptoms, insomnia, and concentration and memory problems.19

The results of this study indicate that one-third of participating nurses were experiencing moral distress. Burton et al described COVID-19 as an environment in which nurses witnessed, experienced, and at times had to participate in acts that involved ethical violations in care, institutional betrayal, and traumatic strain.9 Of note, our findings revealed that both inpatient and outpatient nurses experienced moral distress. Interestingly, Mantri et al found that COVID-19 increased moral injury but not burnout among health professionals, which differed from the results of this study.35

The findings of this study indicate that many nurses experienced depressive symptoms. A systematic review found a similar percentage of HCWs experienced depression while caring for patients with COVID- 19, though a Chinese study found a higher percentage.36,37 Previous research also found that the most difficult aspect of the COVID- 19 pandemic for nurses was coping with mental disorders such as depression, and that many experienced difficulty sleeping/ had poor sleep quality, believed a similar disaster would occur in the future, were irritated or angered easily, and experienced emotional exhaustion.15,19 The long-term mental and physical ramifications of caring for individuals with COVID-19 remain unknown. However, previous research suggests a high prevalence of depression, insomnia, anxiety, and distress, which could impair nurses’ professional performance.29

This study reported that a majority of nurses intended to stay in their current position and about 20% intended to leave for another position within the VA. Similar findings conducted early in the pandemic indicated that most participants did not intend to quit nursing.19

This study’s findings suggest the COVID-19 pandemic had an adverse impact on VISN 21 nurses. It is critical to develop, implement, and adopt adequate measures as early as possible to support the health care system, especially nurses.18

Implications

Before the COVID-19 pandemic, discussing burnout and moral anguish was common, primarily in critical care.14 However, these experiences became more widespread throughout nursing settings during the pandemic. Nurse leaders have been identified as responsible for ensuring the environmental safety and personal well-being of their colleagues during and after pandemics.14

Studies of HCW experiences during COVID-19 provide many insights into future preparedness, strategies to best handle another pandemic during its acute stage, and techniques to address issues that might persist. This study and others suggest that comprehensive interventions in preparation for, during, and after a pandemic are needed. We break down strategies into pandemic and postpandemic interventions based on a synthesis of the literature and the research team’s knowledge and expertise.3,14-16,27,29,36,38-44

Pandemic interventions. During a pandemic, it is important that nurses are adequately cared for to ensure they can continue to provide quality care for others. Resources supporting emotional well-being and addressing moral distress offered during a pandemic are essential. Implementing meaningful strategies could enhance nurses’ health and wellbeing. It is essential that leaders provide nurses a safe work environment/experience during a pandemic by instituting meaningful resources. In addition, developing best practices for leadership are critical.

Postpandemic interventions. Personal experiences of depression, burnout, and moral distress have not spontaneously resolved as the pandemic receded. Providing postpandemic interventions to lessen ongoing and lingering depressive, burnout, and moral distress symptoms experienced by frontline workers are critical. These interventions might prevent long-term health issues and the exodus of nurses.

Postpandemic interventions should include the integration of pandemic planning into new or existing educational or training programs for staff. Promotion and support of mental health services by health system leadership for nursing personnel implemented as a usual service will play an important role in preparing for future pandemics. A key role in preparation is developing and maintaining cooperation and ongoing mutual understanding, respect, and communication between leadership and nursing staff.

Future Research

This study’s findings inform VHA leadership and society about how a large group of nurses were impacted by COVID-19 while caring for patients in inpatient and outpatient settings and could provide a basis for extending this research to other groups of nurses or health care personnel. Future research might be helpful in identifying the impact of COVID-19 on nursing leadership. During conversations with nursing leadership, a common theme identified was that nurses did not feel that leadership was fully prepared for the level of emergency the pandemic created both personally and professionally; leadership expressed experiences similar to nurses providing direct care and felt powerless to help their nursing staff. Other areas of research could include identifying underlying factors contributing to burnout and moral distress and describing nurses’ expectations of or needs from leadership to best manage burnout and moral distress.

Limitations

Experiences of nurses who stopped working were not captured and information about their experiences might have different results. The survey distribution was limited to 2 emails (an initial email and a second at midpoint) sent at the discretion of the nurse executive of each facility. The study timeline was long because of complex regulatory protective processes inherent in the VHA system for researchers to include initial institutional review board review process, union notifications, and each facility’s response to the survey. Although 860 nurses participated, this was 15% of the 5586 VISN 21 nurses at the time of the study. Many clinical inpatient nurses do not have regular access to email, which might have impacted participation rate.

CONCLUSIONS

This study identified the impact COVID-19 had on nurses who worked in a large hospital system. The research team outlined strategies to be employed during and after the pandemic, such as preplanning for future pandemics to provide a framework for a comprehensive pandemic response protocol.

This study adds to generalized knowledge because it captured voices of inpatient and outpatient nurses, the latter had not been previously studied. As nurses and health care organizations move beyond the pandemic with a significant number of nurses continuing to experience effects, there is a need to institute interventions to assist nurses in healing and begin preparations for future pandemics.

References
  1. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506. doi:10.1016/S0140-6736(20)30183-5
  2. Liu X, Kakade M, Fuller CJ, et al. Depression after exposure to stressful events: lessons learned from the severe acute respiratory syndrome epidemic. Compr Psychiatry. 2012;53(1):15-23. doi:10.1016/j.comppsych.2011.02.003
  3. Carmassi C, Foghi C, Dell’Oste V, et al. PTSD symptoms in healthcare workers facing the three coronavirus outbreaks: What can we expect after the COVID-19 pandemic. Psychiatry Res. 2020;292:113312. doi:10.1016/j.psychres.2020.113312
  4. De Kock JH, Latham HA, Leslie SJ, et al. A rapid review of the impact of COVID-19 on the mental health of healthcare workers: implications for supporting psychological well-being. BMC Public Health. 2021;21(1):104. doi:10.1186/s12889-020-10070-3
  5. Gualano MR, Sinigaglia T, Lo Moro G, et al. The burden of burnout among healthcare professionals of intensive care units and emergency departments during the covid-19 pandemic: a systematic review. Int J Environ Res Public Health. 2021;18(15):8172. doi:10.3390/ijerph18158172
  6. Sirois FM, Owens J. Factors associated with psychological distress in health-care workers during an infectious disease outbreak: a rapid systematic review of the evidence. Front Psychiatry. 2020;11;589545. doi:10.3389/fpsyt.2020.589545
  7. Talevi D, Socci V, Carai M, et al. Mental health outcomes of the COVID-19 pandemic. Riv Psichiatr. 2020;55(3);137-144. doi:10.1708/3382.33569
  8. Amsalem D, Lazarov A, Markowitz JC, et al. Psychiatric symptoms and moral injury among US healthcare workers in the COVID-19 era. BMC Psychiatry. 2021;21(1):546. doi:10.1186/s12888-021-03565-9
  9. Burton CW, Jenkins DK, Chan G.K, Zellner KL, Zalta AK. A mixed methods study of moral distress among frontline nurses during the COVID-19 pandemic. Psychol Trauma. 2023;16(4):568-575. doi:10.1037/tra0001493
  10. Stawicki SP, Jeanmonod R, Miller AC, et al. The 2019- 2020 novel coronavirus (Severe acute respiratory syndrome coronavirus 2) Pandemic:a Joint American College of Academic International Medicine-World Academic Council of Emergency Medicine Multidisciplinary COVID-19 Working Group consensus paper. J Glob Infect Dis. 2020;12(2):47- 93. doi:10.4103/jgid.jgid_86_20
  11. Batra K, Singh TP, Sharma M, Batra R, Schvaneveldt N. Investigating the psychological impact of COVID- 19 among healthcare workers: a meta-analysis. Int J Environ Res Public Health. 2020;17(23):9096. doi:10.3390/ijerph17239096
  12. Xie W, Chen L, Feng F, et al. The prevalence of compassion satisfaction and compassion fatigue among nurses: a systematic review and meta-analysis. Int J Nurs Stud. 2021;120:103973. doi:10.1016/j.ijnurstu.2021.103973
  13. Galanis P, Vraka I, Fragkou D, Bilali A, Kaitelidou D. Nurses’ burnout and associated risk factors during the COVID-19 pandemic: a systematic review and meta-analysis. J Adv Nurs. 2021;77(8):3286-3302. doi:10.1111/jan.14839
  14. Hofmeyer A, Taylor R. Strategies and resources for nurse leaders to use to lead with empathy and prudence so they understand and address sources of anxiety among nurses practicing in the era of COVID-19. J Clin Nurs. 2021;30(1- 2):298-305. doi:10.1111/jocn.15520
  15. Chen R, Sun C, Chen JJ, et al. A large-scale survey on trauma, burnout, and posttraumatic growth among nurses during the COVID-19 pandemic. Int J Ment Health Nurs. 2021;30(1):102-116. doi:10.1111/inm.12796
  16. García G, Calvo J. The threat of COVID-19 and its influence on nursing staff burnout. J Adv Nurs. 2021;77(2):832-844. doi:10.1111/jan.14642
  17. Kissel KA, Filipek C, Jenkins J. Impact of the COVID- 19 pandemic on nurses working in intensive care units: a scoping review. Crit Care Nurse. 2023;43(2):55-63. doi:10.4037/ccn2023196
  18. Lin YY, Pan YA, Hsieh YL, et al. COVID-19 pandemic is associated with an adverse impact on burnout and mood disorder in healthcare professionals. Int J Environ Res and Public Health. 2021;18(7):3654. doi:10.3390/ijerph18073654
  19. Murat M, Köse S, Savas¸er S. Determination of stress, depression and burnout levels of front-line nurses during the COVID-19 pandemic. Int J Ment Health Nurs. 2021;30(2):533-543. doi:10.1111/inm.12818
  20. Purcell N, Bertenthal D, Usman H, et al. Moral injury and mental health in healthcare workers are linked to organizational culture and modifiable workplace conditions: results of a national, mixed-methods study conducted at Veterans Affairs (VA) medical centers during the COVID- 19 pandemic. PLOS Ment Health. 2024;1(7):e0000085. doi:10.1371/journal.pmen.0000085
  21. Nash WP, Marino Carper TL, Mills MA, Au T, Goldsmith A, Litz BT. Psychometric evaluation of the Moral Injury Events Scale. Mil Med. 2013;178(6):646-652. doi:10.7205/MILMED-D-13-00017
  22. Prins A, Bovin MJ, Smolenski DJ, et al. The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): development and evaluation within a veteran primary care sample. J Gen Intern Med. 2016;31(10):1206-1211. doi:10.1007/s11606-016-3703-5
  23. Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003;41(11):1284-1292. doi:10.1097/01.MLR.0000093487.78664.3C
  24. Rohland BM, Kruse GR, Rohrer JE. Validation of a single- item measure of burnout against the Maslach Burnout Inventory among physicians. Stress and Health. 2004;20(2):75-79. doi:10.1002/smi.1002
  25. Carlson J. Baccalaureate nursing faculty competencies and teaching strategies to enhance the care of the veteran population: perspectives of Veteran Affairs Nursing Academy (VANA) faculty. J Prof Nurs. 2016;32(4):314-323. doi:10.1016/j.profnurs.2016.01.006
  26. Denning M, Goh ET, Tan B, et al. Determinants of burnout and other aspects of psychological well-being in healthcare workers during the Covid-19 pandemic: a multinational cross-sectional study. PloS One. 2021;16(4):e0238666. doi:10.1371/journal.pone.0238666
  27. Howell BAM. Battling burnout at the frontlines of health care amid COVID-19. AACN Adv Crit Care. 2021;32(2):195- 203. doi:10.4037/aacnacc2021454
  28. Afshari D, Nourollahi-Darabad M, Chinisaz N. Demographic predictors of resilience among nurses during the COVID-19 pandemic. Work. 2021;68(2):297-303. doi:10.3233/WOR-203376
  29. Shah M, Roggenkamp M, Ferrer L, Burger V, Brassil KJ. Mental health and COVID-19: the psychological implications of a pandemic for nurses. Clin J Oncol Nurs. 2021;25(1), 69-75. doi:10.1188/21.CJON.69-75
  30. Griner T, Souza M, Girard A, Hain P, High H, Williams M. COVID-19’s impact on nurses’ workplace rituals. Nurs Lead. 2021;19(4):425-430. doi:10.1016/j.mnl.2021.06.008
  31. Koren A, Alam MAU, Koneru S, DeVito A, Abdallah L, Liu B. Nursing perspectives on the impacts of COVID- 19: social media content analysis. JMIR Form Res. 2021;5(12):e31358. doi:10.2196/31358
  32. Gold JA. Covid-19: adverse mental health outcomes for healthcare workers. BMJ. 2020;5:369:m1815. doi: 10.1136/bmj.m1815. doi:10.1136/bmj.m1815
  33. Slusarz R, Cwiekala-Lewis K, Wysokinski M, Filipska- Blejder K, Fidecki W, Biercewicz M. Characteristics of occupational burnout among nurses of various specialties and in the time of the COVID-19 pandemic-review. Int J Environ Res Public Health. 2022;19(21):13775. doi:10.3390/ijerph192113775
  34. Soto-Rubio A, Giménez-Espert MDC, Prado-Gascó V. Effect of emotional intelligence and psychosocial risks on burnout, job satisfaction, and nurses’ health during the COVID-19 pandemic. Int J Environ Res Public Health. 2020;17(21):7998. doi:10.3390/ijerph17217998
  35. Mantri S, Song YK, Lawson JM, Berger EJ, Koenig HG. Moral injury and burnout in health care professionals during the COVID-19 pandemic. J Nerv Ment Dis. 2021;209(10):720-726. doi:10.1097/NMD.0000000000001367
  36. Salari N, Khazaie H, Hosseinian-Far A, et al. The prevalence of stress, anxiety and depression within front-line healthcare workers caring for COVID-19 patients: a systematic review and meta-regression. Hum Resour Health 2020;18(1):100. doi:10.1186/s12960-020-00544-1
  37. Lai J, Ma S, Wang Y, et al. Factors associated with mental health outcomes among health care workers exposed to coronavirus disease 2019. JAMA Netw Open. 2020;3(3):e203976. doi:10.1001/jamanetworkopen.2020.3976
  38. Chesak SS, Cutshall SM, Bowe CL, Montanari KM, Bhagra A. Stress management interventions for nurses: critical literature review. J Holist Nurs. 2019;37(3):288-295. doi:10.1177/0898010119842693
  39. Cooper AL, Brown JA, Leslie GD. Nurse resilience for clinical practice: an integrative review. J Adv Nurs. 2021;77(6):2623-2640. doi:10.1111/jan.14763
  40. Melnyk BM, Kelly SA, Stephens J, et al. Interventions to improve mental health, well-being, physical health, and lifestyle behaviors in physicians and nurses: a systematic review. Am J Health Promot. 2020;34(8):929-941. doi:10.1177/0890117120920451
  41. Cho H, Sagherian K, Steege LM. Hospital staff nurse perceptions of resources and resource needs during the COVID-19 pandemic. Nurs Outlook. 2023;71(3):101984. doi:10.1016/j.outlook.2023.101984
  42. Bachem R, Tsur N, Levin Y, Abu-Raiya H, Maercker A. Negative affect, fatalism, and perceived institutional betrayal in times of the coronavirus pandemic: a cross-cultural investigation of control beliefs. Front Psychiatry. 2020;11:589914. doi:10.3389/fpsyt.2020.589914
  43. Shanafelt T, Ripp J, Trockel M. Understanding and addressing sources of anxiety among health care professionals during the COVID-19 pandemic. JAMA. 2020;323(21):2133. doi:10.1001/jama.2020.5893
  44. Schuster M, Dwyer PA. Post-traumatic stress disorder in nurses: an integrative review. J Clin Nurs. 2020;29(15- 16):2769-2787. doi:10.1111/jocn.15288
References
  1. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506. doi:10.1016/S0140-6736(20)30183-5
  2. Liu X, Kakade M, Fuller CJ, et al. Depression after exposure to stressful events: lessons learned from the severe acute respiratory syndrome epidemic. Compr Psychiatry. 2012;53(1):15-23. doi:10.1016/j.comppsych.2011.02.003
  3. Carmassi C, Foghi C, Dell’Oste V, et al. PTSD symptoms in healthcare workers facing the three coronavirus outbreaks: What can we expect after the COVID-19 pandemic. Psychiatry Res. 2020;292:113312. doi:10.1016/j.psychres.2020.113312
  4. De Kock JH, Latham HA, Leslie SJ, et al. A rapid review of the impact of COVID-19 on the mental health of healthcare workers: implications for supporting psychological well-being. BMC Public Health. 2021;21(1):104. doi:10.1186/s12889-020-10070-3
  5. Gualano MR, Sinigaglia T, Lo Moro G, et al. The burden of burnout among healthcare professionals of intensive care units and emergency departments during the covid-19 pandemic: a systematic review. Int J Environ Res Public Health. 2021;18(15):8172. doi:10.3390/ijerph18158172
  6. Sirois FM, Owens J. Factors associated with psychological distress in health-care workers during an infectious disease outbreak: a rapid systematic review of the evidence. Front Psychiatry. 2020;11;589545. doi:10.3389/fpsyt.2020.589545
  7. Talevi D, Socci V, Carai M, et al. Mental health outcomes of the COVID-19 pandemic. Riv Psichiatr. 2020;55(3);137-144. doi:10.1708/3382.33569
  8. Amsalem D, Lazarov A, Markowitz JC, et al. Psychiatric symptoms and moral injury among US healthcare workers in the COVID-19 era. BMC Psychiatry. 2021;21(1):546. doi:10.1186/s12888-021-03565-9
  9. Burton CW, Jenkins DK, Chan G.K, Zellner KL, Zalta AK. A mixed methods study of moral distress among frontline nurses during the COVID-19 pandemic. Psychol Trauma. 2023;16(4):568-575. doi:10.1037/tra0001493
  10. Stawicki SP, Jeanmonod R, Miller AC, et al. The 2019- 2020 novel coronavirus (Severe acute respiratory syndrome coronavirus 2) Pandemic:a Joint American College of Academic International Medicine-World Academic Council of Emergency Medicine Multidisciplinary COVID-19 Working Group consensus paper. J Glob Infect Dis. 2020;12(2):47- 93. doi:10.4103/jgid.jgid_86_20
  11. Batra K, Singh TP, Sharma M, Batra R, Schvaneveldt N. Investigating the psychological impact of COVID- 19 among healthcare workers: a meta-analysis. Int J Environ Res Public Health. 2020;17(23):9096. doi:10.3390/ijerph17239096
  12. Xie W, Chen L, Feng F, et al. The prevalence of compassion satisfaction and compassion fatigue among nurses: a systematic review and meta-analysis. Int J Nurs Stud. 2021;120:103973. doi:10.1016/j.ijnurstu.2021.103973
  13. Galanis P, Vraka I, Fragkou D, Bilali A, Kaitelidou D. Nurses’ burnout and associated risk factors during the COVID-19 pandemic: a systematic review and meta-analysis. J Adv Nurs. 2021;77(8):3286-3302. doi:10.1111/jan.14839
  14. Hofmeyer A, Taylor R. Strategies and resources for nurse leaders to use to lead with empathy and prudence so they understand and address sources of anxiety among nurses practicing in the era of COVID-19. J Clin Nurs. 2021;30(1- 2):298-305. doi:10.1111/jocn.15520
  15. Chen R, Sun C, Chen JJ, et al. A large-scale survey on trauma, burnout, and posttraumatic growth among nurses during the COVID-19 pandemic. Int J Ment Health Nurs. 2021;30(1):102-116. doi:10.1111/inm.12796
  16. García G, Calvo J. The threat of COVID-19 and its influence on nursing staff burnout. J Adv Nurs. 2021;77(2):832-844. doi:10.1111/jan.14642
  17. Kissel KA, Filipek C, Jenkins J. Impact of the COVID- 19 pandemic on nurses working in intensive care units: a scoping review. Crit Care Nurse. 2023;43(2):55-63. doi:10.4037/ccn2023196
  18. Lin YY, Pan YA, Hsieh YL, et al. COVID-19 pandemic is associated with an adverse impact on burnout and mood disorder in healthcare professionals. Int J Environ Res and Public Health. 2021;18(7):3654. doi:10.3390/ijerph18073654
  19. Murat M, Köse S, Savas¸er S. Determination of stress, depression and burnout levels of front-line nurses during the COVID-19 pandemic. Int J Ment Health Nurs. 2021;30(2):533-543. doi:10.1111/inm.12818
  20. Purcell N, Bertenthal D, Usman H, et al. Moral injury and mental health in healthcare workers are linked to organizational culture and modifiable workplace conditions: results of a national, mixed-methods study conducted at Veterans Affairs (VA) medical centers during the COVID- 19 pandemic. PLOS Ment Health. 2024;1(7):e0000085. doi:10.1371/journal.pmen.0000085
  21. Nash WP, Marino Carper TL, Mills MA, Au T, Goldsmith A, Litz BT. Psychometric evaluation of the Moral Injury Events Scale. Mil Med. 2013;178(6):646-652. doi:10.7205/MILMED-D-13-00017
  22. Prins A, Bovin MJ, Smolenski DJ, et al. The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): development and evaluation within a veteran primary care sample. J Gen Intern Med. 2016;31(10):1206-1211. doi:10.1007/s11606-016-3703-5
  23. Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003;41(11):1284-1292. doi:10.1097/01.MLR.0000093487.78664.3C
  24. Rohland BM, Kruse GR, Rohrer JE. Validation of a single- item measure of burnout against the Maslach Burnout Inventory among physicians. Stress and Health. 2004;20(2):75-79. doi:10.1002/smi.1002
  25. Carlson J. Baccalaureate nursing faculty competencies and teaching strategies to enhance the care of the veteran population: perspectives of Veteran Affairs Nursing Academy (VANA) faculty. J Prof Nurs. 2016;32(4):314-323. doi:10.1016/j.profnurs.2016.01.006
  26. Denning M, Goh ET, Tan B, et al. Determinants of burnout and other aspects of psychological well-being in healthcare workers during the Covid-19 pandemic: a multinational cross-sectional study. PloS One. 2021;16(4):e0238666. doi:10.1371/journal.pone.0238666
  27. Howell BAM. Battling burnout at the frontlines of health care amid COVID-19. AACN Adv Crit Care. 2021;32(2):195- 203. doi:10.4037/aacnacc2021454
  28. Afshari D, Nourollahi-Darabad M, Chinisaz N. Demographic predictors of resilience among nurses during the COVID-19 pandemic. Work. 2021;68(2):297-303. doi:10.3233/WOR-203376
  29. Shah M, Roggenkamp M, Ferrer L, Burger V, Brassil KJ. Mental health and COVID-19: the psychological implications of a pandemic for nurses. Clin J Oncol Nurs. 2021;25(1), 69-75. doi:10.1188/21.CJON.69-75
  30. Griner T, Souza M, Girard A, Hain P, High H, Williams M. COVID-19’s impact on nurses’ workplace rituals. Nurs Lead. 2021;19(4):425-430. doi:10.1016/j.mnl.2021.06.008
  31. Koren A, Alam MAU, Koneru S, DeVito A, Abdallah L, Liu B. Nursing perspectives on the impacts of COVID- 19: social media content analysis. JMIR Form Res. 2021;5(12):e31358. doi:10.2196/31358
  32. Gold JA. Covid-19: adverse mental health outcomes for healthcare workers. BMJ. 2020;5:369:m1815. doi: 10.1136/bmj.m1815. doi:10.1136/bmj.m1815
  33. Slusarz R, Cwiekala-Lewis K, Wysokinski M, Filipska- Blejder K, Fidecki W, Biercewicz M. Characteristics of occupational burnout among nurses of various specialties and in the time of the COVID-19 pandemic-review. Int J Environ Res Public Health. 2022;19(21):13775. doi:10.3390/ijerph192113775
  34. Soto-Rubio A, Giménez-Espert MDC, Prado-Gascó V. Effect of emotional intelligence and psychosocial risks on burnout, job satisfaction, and nurses’ health during the COVID-19 pandemic. Int J Environ Res Public Health. 2020;17(21):7998. doi:10.3390/ijerph17217998
  35. Mantri S, Song YK, Lawson JM, Berger EJ, Koenig HG. Moral injury and burnout in health care professionals during the COVID-19 pandemic. J Nerv Ment Dis. 2021;209(10):720-726. doi:10.1097/NMD.0000000000001367
  36. Salari N, Khazaie H, Hosseinian-Far A, et al. The prevalence of stress, anxiety and depression within front-line healthcare workers caring for COVID-19 patients: a systematic review and meta-regression. Hum Resour Health 2020;18(1):100. doi:10.1186/s12960-020-00544-1
  37. Lai J, Ma S, Wang Y, et al. Factors associated with mental health outcomes among health care workers exposed to coronavirus disease 2019. JAMA Netw Open. 2020;3(3):e203976. doi:10.1001/jamanetworkopen.2020.3976
  38. Chesak SS, Cutshall SM, Bowe CL, Montanari KM, Bhagra A. Stress management interventions for nurses: critical literature review. J Holist Nurs. 2019;37(3):288-295. doi:10.1177/0898010119842693
  39. Cooper AL, Brown JA, Leslie GD. Nurse resilience for clinical practice: an integrative review. J Adv Nurs. 2021;77(6):2623-2640. doi:10.1111/jan.14763
  40. Melnyk BM, Kelly SA, Stephens J, et al. Interventions to improve mental health, well-being, physical health, and lifestyle behaviors in physicians and nurses: a systematic review. Am J Health Promot. 2020;34(8):929-941. doi:10.1177/0890117120920451
  41. Cho H, Sagherian K, Steege LM. Hospital staff nurse perceptions of resources and resource needs during the COVID-19 pandemic. Nurs Outlook. 2023;71(3):101984. doi:10.1016/j.outlook.2023.101984
  42. Bachem R, Tsur N, Levin Y, Abu-Raiya H, Maercker A. Negative affect, fatalism, and perceived institutional betrayal in times of the coronavirus pandemic: a cross-cultural investigation of control beliefs. Front Psychiatry. 2020;11:589914. doi:10.3389/fpsyt.2020.589914
  43. Shanafelt T, Ripp J, Trockel M. Understanding and addressing sources of anxiety among health care professionals during the COVID-19 pandemic. JAMA. 2020;323(21):2133. doi:10.1001/jama.2020.5893
  44. Schuster M, Dwyer PA. Post-traumatic stress disorder in nurses: an integrative review. J Clin Nurs. 2020;29(15- 16):2769-2787. doi:10.1111/jocn.15288
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Two Cystic Duct Stents Appear Better Than One

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Placing two cystic duct stents instead of one during endoscopic transpapillary gallbladder drainage (ETGBD) is associated with a lower rate of unplanned reintervention, according to a retrospective multicenter study.

These findings suggest that endoscopists should prioritize dual stent placement when feasible, and consider adding a second stent in patients who previously received a single stent, James D. Haddad, MD, of the University of Texas Southwestern, Dallas, and colleagues reported.

 

Dr. James D. Haddad

The American Gastroenterological Association (AGA) has recognized the role of endoscopic drainage in managing acute cholecystitis in high-risk patients, but specific guidance on optimal technique and follow-up remains unclear, the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

“Despite accumulating data and increased interest in this technique, clear guidance on the ideal strategy for ETGBD is lacking,” Dr. Haddad and colleagues wrote. “For example, the optimal size, number, and follow-up of cystic duct stents for patients undergoing ETGBD has not been well established.”

To address this knowledge gap, the investigators analyzed data from 75 patients at five academic medical centers who had undergone ETGBD between June 2013 and October 2022. Patients were divided into two groups based on whether they received one or two cystic duct stents. 

The primary outcome was clinical success, defined as symptom resolution without requiring another drainage procedure. Secondary outcomes included technical success (defined as successful stent placement), along with rates of adverse events and unplanned reinterventions. 

Out of the 75 patients, 59 received a single stent, while 16 received dual stents. The median follow-up time was 407 days overall, with a longer follow-up in the single-stent group (433 days), compared with the double-stent group (118 days).

Clinical success was reported in 81.3% of cases, which technical success was achieved in 88.2% of cases. 

Patients who received two stents had significantly lower rates of unplanned reintervention, compared with those who received a single stent (0% vs 25.4%; P = .02). The median time to unplanned reintervention in the single-stent group was 210 days.

Use of a 7 French stent was strongly associated with placement of two stents (odd ratio [OR], 15.5; P = .01). Similarly, patients with a prior percutaneous cholecystostomy tube were significantly more likely to have two stents placed (OR, 10.8; P = .001).

Adverse event rates were uncommon and not statistically different between groups, with an overall rate of 6.7%. Post-endoscopic retrograde cholangiopancreatography pancreatitis was the most common adverse event, occurring in two patients in the single-stent group and one patient in the double-stent group. There were no reported cases of cystic duct or gallbladder perforation.

“In conclusion,” the investigators wrote, “ETGBD with dual transpapillary gallbladder stenting is associated with a lower rate of unplanned reinterventions, compared with that with single stenting, and has a low rate of adverse events. Endoscopists performing ETGBD should consider planned exchange of solitary transpapillary gallbladder stents or interval ERCP for reattempted placement of a second stent if placement of two stents is not possible at the index ERCP.”

The investigators disclosed relationships with Boston Scientific, Motus GI, and ConMed.







 

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Placing two cystic duct stents instead of one during endoscopic transpapillary gallbladder drainage (ETGBD) is associated with a lower rate of unplanned reintervention, according to a retrospective multicenter study.

These findings suggest that endoscopists should prioritize dual stent placement when feasible, and consider adding a second stent in patients who previously received a single stent, James D. Haddad, MD, of the University of Texas Southwestern, Dallas, and colleagues reported.

 

Dr. James D. Haddad

The American Gastroenterological Association (AGA) has recognized the role of endoscopic drainage in managing acute cholecystitis in high-risk patients, but specific guidance on optimal technique and follow-up remains unclear, the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

“Despite accumulating data and increased interest in this technique, clear guidance on the ideal strategy for ETGBD is lacking,” Dr. Haddad and colleagues wrote. “For example, the optimal size, number, and follow-up of cystic duct stents for patients undergoing ETGBD has not been well established.”

To address this knowledge gap, the investigators analyzed data from 75 patients at five academic medical centers who had undergone ETGBD between June 2013 and October 2022. Patients were divided into two groups based on whether they received one or two cystic duct stents. 

The primary outcome was clinical success, defined as symptom resolution without requiring another drainage procedure. Secondary outcomes included technical success (defined as successful stent placement), along with rates of adverse events and unplanned reinterventions. 

Out of the 75 patients, 59 received a single stent, while 16 received dual stents. The median follow-up time was 407 days overall, with a longer follow-up in the single-stent group (433 days), compared with the double-stent group (118 days).

Clinical success was reported in 81.3% of cases, which technical success was achieved in 88.2% of cases. 

Patients who received two stents had significantly lower rates of unplanned reintervention, compared with those who received a single stent (0% vs 25.4%; P = .02). The median time to unplanned reintervention in the single-stent group was 210 days.

Use of a 7 French stent was strongly associated with placement of two stents (odd ratio [OR], 15.5; P = .01). Similarly, patients with a prior percutaneous cholecystostomy tube were significantly more likely to have two stents placed (OR, 10.8; P = .001).

Adverse event rates were uncommon and not statistically different between groups, with an overall rate of 6.7%. Post-endoscopic retrograde cholangiopancreatography pancreatitis was the most common adverse event, occurring in two patients in the single-stent group and one patient in the double-stent group. There were no reported cases of cystic duct or gallbladder perforation.

“In conclusion,” the investigators wrote, “ETGBD with dual transpapillary gallbladder stenting is associated with a lower rate of unplanned reinterventions, compared with that with single stenting, and has a low rate of adverse events. Endoscopists performing ETGBD should consider planned exchange of solitary transpapillary gallbladder stents or interval ERCP for reattempted placement of a second stent if placement of two stents is not possible at the index ERCP.”

The investigators disclosed relationships with Boston Scientific, Motus GI, and ConMed.







 

Placing two cystic duct stents instead of one during endoscopic transpapillary gallbladder drainage (ETGBD) is associated with a lower rate of unplanned reintervention, according to a retrospective multicenter study.

These findings suggest that endoscopists should prioritize dual stent placement when feasible, and consider adding a second stent in patients who previously received a single stent, James D. Haddad, MD, of the University of Texas Southwestern, Dallas, and colleagues reported.

 

Dr. James D. Haddad

The American Gastroenterological Association (AGA) has recognized the role of endoscopic drainage in managing acute cholecystitis in high-risk patients, but specific guidance on optimal technique and follow-up remains unclear, the investigators wrote in Techniques and Innovations in Gastrointestinal Endoscopy.

“Despite accumulating data and increased interest in this technique, clear guidance on the ideal strategy for ETGBD is lacking,” Dr. Haddad and colleagues wrote. “For example, the optimal size, number, and follow-up of cystic duct stents for patients undergoing ETGBD has not been well established.”

To address this knowledge gap, the investigators analyzed data from 75 patients at five academic medical centers who had undergone ETGBD between June 2013 and October 2022. Patients were divided into two groups based on whether they received one or two cystic duct stents. 

The primary outcome was clinical success, defined as symptom resolution without requiring another drainage procedure. Secondary outcomes included technical success (defined as successful stent placement), along with rates of adverse events and unplanned reinterventions. 

Out of the 75 patients, 59 received a single stent, while 16 received dual stents. The median follow-up time was 407 days overall, with a longer follow-up in the single-stent group (433 days), compared with the double-stent group (118 days).

Clinical success was reported in 81.3% of cases, which technical success was achieved in 88.2% of cases. 

Patients who received two stents had significantly lower rates of unplanned reintervention, compared with those who received a single stent (0% vs 25.4%; P = .02). The median time to unplanned reintervention in the single-stent group was 210 days.

Use of a 7 French stent was strongly associated with placement of two stents (odd ratio [OR], 15.5; P = .01). Similarly, patients with a prior percutaneous cholecystostomy tube were significantly more likely to have two stents placed (OR, 10.8; P = .001).

Adverse event rates were uncommon and not statistically different between groups, with an overall rate of 6.7%. Post-endoscopic retrograde cholangiopancreatography pancreatitis was the most common adverse event, occurring in two patients in the single-stent group and one patient in the double-stent group. There were no reported cases of cystic duct or gallbladder perforation.

“In conclusion,” the investigators wrote, “ETGBD with dual transpapillary gallbladder stenting is associated with a lower rate of unplanned reinterventions, compared with that with single stenting, and has a low rate of adverse events. Endoscopists performing ETGBD should consider planned exchange of solitary transpapillary gallbladder stents or interval ERCP for reattempted placement of a second stent if placement of two stents is not possible at the index ERCP.”

The investigators disclosed relationships with Boston Scientific, Motus GI, and ConMed.







 

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FROM TECHNIQUES AND INNOVATIONS IN GASTROINTESTINAL ENDOSCOPY

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Violaceous Papules on Face

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Discussion

The patient’s violaceous papule on the nose with an apple jelly appearance is consistent with lupus pernio—a cutaneous form of sarcoidosis associated with respiratory involvement. Lupus pernio disproportionately affects African Americans, which further supports this diagnosis.1 Lupus pernio is characterized by violaceous, indurated plaques predominantly on the face. It has a strong association with systemic sarcoidosis and often involves the lungs and other organs, as seen in this case. The laboratory results support this diagnosis. Hypercalcemia is a common systemic manifestation of sarcoidosis due to increased production of 1,25-dihydroxyvitamin D by activated macrophages with granulomas.2 Elevated chitotriosidase, an enzyme produced by macrophages, is another biomarker of sarcoidosis reflecting granuloma burden.3

The differential diagnoses included Langerhans cell histiocytosis (LCH), discoid lupus erythematosus, granulomatosis with polyangiitis, and granuloma annulare. However, these diagnoses did not fully align with the entirety of the patient’s clinical presentation and laboratory findings. LCH is a rare neoplastic disorder characterized by the abnormal proliferation and accumulation of Langerhans cells, a type of dendritic cell involved in immune response, in various tissues such as the skin and bone. Dermatologic findings in LCH include brown/purple papules and an erythematous papular rash rather than the violaceous plaques/papules in lupus pernio. LCH can have lung involvement; it typically presents with nodular or cystic changes in the upper lobes as opposed to the bibasilar opacities seen in this case.

Discoid lupus erythematosus presents with characteristic round, erythematous, scaly plaques on the cheeks, scalp, and ears. This is different from the apple jelly appearance seen in this case and does not present with systemic granulomatous involvement.

Typical manifestations of granulomatosis with polyangiitis, formerly known as Wegener’s granulomatosis, include renal disease, upper and lower respiratory tract involvement, or necrotizing vasculitis. Cutaneous manifestions of granulomatosis with polyangiitis typically include purpura or ulcers rather than the violaceous plaques seen in lupus pernio. Patients with granulomatosis with polyangiitis would also present with nonspecific systemic symptoms such as fever, weight loss, and malaise, which are not depicted in this case.4

Granuloma annulare is a benign condition that often presents with annular plaques that are skin-colored rather than violaceous. These plaques are often found on the hands and feet rather than the face. This condition also lacks the systemic manifestations seen in this case.

In primary care, encountering violaceous papule and plaques on the face, especially on the nasal alae or ear, should be concerning for possible lupus pernio, particularly in high-risk populations such as young African Americans. These lesions generally have a more indurated “deep” and “doughy” appearance and can result in scarring, distinguishing them from other types of cutaneous sarcoidosis. An apple jelly appearance seen on diascopy with a glass slide can further support the diagnosis. While the lesions are typically asymptomatic, patients may be concerned about potential cosmetic disfigurement. Given the potential for scarring and the association with systemic sarcoidosis, a dermatology referral is recommended for further evaluation and management.

A detailed patient history, physical examination, and laboratory exams are essential to accurately diagnose lupus pernio. Biopsy of a skin lesion, serum markers, and imaging studies were utilized to help assess systemic involvement and further confirm diagnosis in this patient. Following the diagnosis, the patient was started on his current regimen of prednisone, methotrexate, and hydroxychloroquine, which are standard therapies for managing both cutaneous and systemic sarcoidosis.

This case shows the importance of recognizing lupus pernio, a distinct form of cutaneous sarcoidosis, in patients presenting with characteristic skin lesions and systemic involvement. It is essential to differentiate it from other granulomatous and inflammatory skin conditions to ensure appropriate management and prevent complications.

Federal Practitioner thanks the Association of Military Dermatologists (militaryderm.org) for their assistance in developing the Image Challenge. Submissions based on photographs, radiography, or any other visual medium are welcomed.

References
  1. Lai J, Almazan E, Le T, Taylor MT, Alhariri J, Kwatra SG. Demographics, cutaneous manifestations, and comorbidities associated with progressive cutaneous sarcoidosis: a retrospective cohort study. Medicines (Basel). 2023;10(10):57. doi:10.3390/medicines10100057
  2. Burke RR, Rybicki BA, Rao DS. Calcium and vitamin D in sarcoidosis: how to assess and manage. Semin Respir Crit Care Med. 2010;31(4):474-484. doi:10.1055/s-0030-1262215
  3. Bargagli E, Maggiorelli C, Rottoli P. Human chitotriosidase: a potential new marker of sarcoidosis severity. Respiration. 2008;76(2):234-238. doi:10.1159/000134009
  4. Kubaisi B, Abu Samra K, Foster CS. Granulomatosis with polyangiitis (Wegener’s disease): An updated review of ocular disease manifestations. Intractable Rare Dis Res. 2016;5(2):61-69. doi:10.5582/irdr.2016.01014
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Fed Pract. 2025;42(3). Published online March 17. doi:10.12788/fp.0561

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Fed Pract. 2025;42(3). Published online March 17. doi:10.12788/fp.0561

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Discussion

The patient’s violaceous papule on the nose with an apple jelly appearance is consistent with lupus pernio—a cutaneous form of sarcoidosis associated with respiratory involvement. Lupus pernio disproportionately affects African Americans, which further supports this diagnosis.1 Lupus pernio is characterized by violaceous, indurated plaques predominantly on the face. It has a strong association with systemic sarcoidosis and often involves the lungs and other organs, as seen in this case. The laboratory results support this diagnosis. Hypercalcemia is a common systemic manifestation of sarcoidosis due to increased production of 1,25-dihydroxyvitamin D by activated macrophages with granulomas.2 Elevated chitotriosidase, an enzyme produced by macrophages, is another biomarker of sarcoidosis reflecting granuloma burden.3

The differential diagnoses included Langerhans cell histiocytosis (LCH), discoid lupus erythematosus, granulomatosis with polyangiitis, and granuloma annulare. However, these diagnoses did not fully align with the entirety of the patient’s clinical presentation and laboratory findings. LCH is a rare neoplastic disorder characterized by the abnormal proliferation and accumulation of Langerhans cells, a type of dendritic cell involved in immune response, in various tissues such as the skin and bone. Dermatologic findings in LCH include brown/purple papules and an erythematous papular rash rather than the violaceous plaques/papules in lupus pernio. LCH can have lung involvement; it typically presents with nodular or cystic changes in the upper lobes as opposed to the bibasilar opacities seen in this case.

Discoid lupus erythematosus presents with characteristic round, erythematous, scaly plaques on the cheeks, scalp, and ears. This is different from the apple jelly appearance seen in this case and does not present with systemic granulomatous involvement.

Typical manifestations of granulomatosis with polyangiitis, formerly known as Wegener’s granulomatosis, include renal disease, upper and lower respiratory tract involvement, or necrotizing vasculitis. Cutaneous manifestions of granulomatosis with polyangiitis typically include purpura or ulcers rather than the violaceous plaques seen in lupus pernio. Patients with granulomatosis with polyangiitis would also present with nonspecific systemic symptoms such as fever, weight loss, and malaise, which are not depicted in this case.4

Granuloma annulare is a benign condition that often presents with annular plaques that are skin-colored rather than violaceous. These plaques are often found on the hands and feet rather than the face. This condition also lacks the systemic manifestations seen in this case.

In primary care, encountering violaceous papule and plaques on the face, especially on the nasal alae or ear, should be concerning for possible lupus pernio, particularly in high-risk populations such as young African Americans. These lesions generally have a more indurated “deep” and “doughy” appearance and can result in scarring, distinguishing them from other types of cutaneous sarcoidosis. An apple jelly appearance seen on diascopy with a glass slide can further support the diagnosis. While the lesions are typically asymptomatic, patients may be concerned about potential cosmetic disfigurement. Given the potential for scarring and the association with systemic sarcoidosis, a dermatology referral is recommended for further evaluation and management.

A detailed patient history, physical examination, and laboratory exams are essential to accurately diagnose lupus pernio. Biopsy of a skin lesion, serum markers, and imaging studies were utilized to help assess systemic involvement and further confirm diagnosis in this patient. Following the diagnosis, the patient was started on his current regimen of prednisone, methotrexate, and hydroxychloroquine, which are standard therapies for managing both cutaneous and systemic sarcoidosis.

This case shows the importance of recognizing lupus pernio, a distinct form of cutaneous sarcoidosis, in patients presenting with characteristic skin lesions and systemic involvement. It is essential to differentiate it from other granulomatous and inflammatory skin conditions to ensure appropriate management and prevent complications.

Federal Practitioner thanks the Association of Military Dermatologists (militaryderm.org) for their assistance in developing the Image Challenge. Submissions based on photographs, radiography, or any other visual medium are welcomed.

Discussion

The patient’s violaceous papule on the nose with an apple jelly appearance is consistent with lupus pernio—a cutaneous form of sarcoidosis associated with respiratory involvement. Lupus pernio disproportionately affects African Americans, which further supports this diagnosis.1 Lupus pernio is characterized by violaceous, indurated plaques predominantly on the face. It has a strong association with systemic sarcoidosis and often involves the lungs and other organs, as seen in this case. The laboratory results support this diagnosis. Hypercalcemia is a common systemic manifestation of sarcoidosis due to increased production of 1,25-dihydroxyvitamin D by activated macrophages with granulomas.2 Elevated chitotriosidase, an enzyme produced by macrophages, is another biomarker of sarcoidosis reflecting granuloma burden.3

The differential diagnoses included Langerhans cell histiocytosis (LCH), discoid lupus erythematosus, granulomatosis with polyangiitis, and granuloma annulare. However, these diagnoses did not fully align with the entirety of the patient’s clinical presentation and laboratory findings. LCH is a rare neoplastic disorder characterized by the abnormal proliferation and accumulation of Langerhans cells, a type of dendritic cell involved in immune response, in various tissues such as the skin and bone. Dermatologic findings in LCH include brown/purple papules and an erythematous papular rash rather than the violaceous plaques/papules in lupus pernio. LCH can have lung involvement; it typically presents with nodular or cystic changes in the upper lobes as opposed to the bibasilar opacities seen in this case.

Discoid lupus erythematosus presents with characteristic round, erythematous, scaly plaques on the cheeks, scalp, and ears. This is different from the apple jelly appearance seen in this case and does not present with systemic granulomatous involvement.

Typical manifestations of granulomatosis with polyangiitis, formerly known as Wegener’s granulomatosis, include renal disease, upper and lower respiratory tract involvement, or necrotizing vasculitis. Cutaneous manifestions of granulomatosis with polyangiitis typically include purpura or ulcers rather than the violaceous plaques seen in lupus pernio. Patients with granulomatosis with polyangiitis would also present with nonspecific systemic symptoms such as fever, weight loss, and malaise, which are not depicted in this case.4

Granuloma annulare is a benign condition that often presents with annular plaques that are skin-colored rather than violaceous. These plaques are often found on the hands and feet rather than the face. This condition also lacks the systemic manifestations seen in this case.

In primary care, encountering violaceous papule and plaques on the face, especially on the nasal alae or ear, should be concerning for possible lupus pernio, particularly in high-risk populations such as young African Americans. These lesions generally have a more indurated “deep” and “doughy” appearance and can result in scarring, distinguishing them from other types of cutaneous sarcoidosis. An apple jelly appearance seen on diascopy with a glass slide can further support the diagnosis. While the lesions are typically asymptomatic, patients may be concerned about potential cosmetic disfigurement. Given the potential for scarring and the association with systemic sarcoidosis, a dermatology referral is recommended for further evaluation and management.

A detailed patient history, physical examination, and laboratory exams are essential to accurately diagnose lupus pernio. Biopsy of a skin lesion, serum markers, and imaging studies were utilized to help assess systemic involvement and further confirm diagnosis in this patient. Following the diagnosis, the patient was started on his current regimen of prednisone, methotrexate, and hydroxychloroquine, which are standard therapies for managing both cutaneous and systemic sarcoidosis.

This case shows the importance of recognizing lupus pernio, a distinct form of cutaneous sarcoidosis, in patients presenting with characteristic skin lesions and systemic involvement. It is essential to differentiate it from other granulomatous and inflammatory skin conditions to ensure appropriate management and prevent complications.

Federal Practitioner thanks the Association of Military Dermatologists (militaryderm.org) for their assistance in developing the Image Challenge. Submissions based on photographs, radiography, or any other visual medium are welcomed.

References
  1. Lai J, Almazan E, Le T, Taylor MT, Alhariri J, Kwatra SG. Demographics, cutaneous manifestations, and comorbidities associated with progressive cutaneous sarcoidosis: a retrospective cohort study. Medicines (Basel). 2023;10(10):57. doi:10.3390/medicines10100057
  2. Burke RR, Rybicki BA, Rao DS. Calcium and vitamin D in sarcoidosis: how to assess and manage. Semin Respir Crit Care Med. 2010;31(4):474-484. doi:10.1055/s-0030-1262215
  3. Bargagli E, Maggiorelli C, Rottoli P. Human chitotriosidase: a potential new marker of sarcoidosis severity. Respiration. 2008;76(2):234-238. doi:10.1159/000134009
  4. Kubaisi B, Abu Samra K, Foster CS. Granulomatosis with polyangiitis (Wegener’s disease): An updated review of ocular disease manifestations. Intractable Rare Dis Res. 2016;5(2):61-69. doi:10.5582/irdr.2016.01014
References
  1. Lai J, Almazan E, Le T, Taylor MT, Alhariri J, Kwatra SG. Demographics, cutaneous manifestations, and comorbidities associated with progressive cutaneous sarcoidosis: a retrospective cohort study. Medicines (Basel). 2023;10(10):57. doi:10.3390/medicines10100057
  2. Burke RR, Rybicki BA, Rao DS. Calcium and vitamin D in sarcoidosis: how to assess and manage. Semin Respir Crit Care Med. 2010;31(4):474-484. doi:10.1055/s-0030-1262215
  3. Bargagli E, Maggiorelli C, Rottoli P. Human chitotriosidase: a potential new marker of sarcoidosis severity. Respiration. 2008;76(2):234-238. doi:10.1159/000134009
  4. Kubaisi B, Abu Samra K, Foster CS. Granulomatosis with polyangiitis (Wegener’s disease): An updated review of ocular disease manifestations. Intractable Rare Dis Res. 2016;5(2):61-69. doi:10.5582/irdr.2016.01014
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A 40-year-old man with no significant medical history or comorbidities presented with a violaceous papule involving his nasal tip and scaly, violaceous plaques with associated alopecia involving his beard (Figure). Skin biopsy confirmed granulomatous dermatitis. Additional workup was notable for hypercalcemia (10.5 mg/dL; reference range, 8.4-10.2 mg/dL), elevated chitotriosidase (317 nmol/h/mL; reference range, < 150 nmol/h/mL), and bibasilar opacities with left perihilar consolidation on chest X-ray. The patient had a prolonged PR interval (207 ms; reference range, 120-200 ms) on electrocardiogram. A cardiac positron emission tomography revealed low level fluorodeoxyglucose uptake in the left ventricle. No ocular involvement was noted on evaluation by ophthalmology. The patient’s pharmacotherapy included prednisone 10 mg daily, methotrexate 7.5 mg weekly, and hydroxychloroquine 200 mg daily.

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Circulating Proteins Predict Crohn’s Disease Years in Advance

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Circulating blood proteins could enable early identification of Crohn’s disease (CD) years before clinical signs, according to investigators.

The 29-protein biosignature, which was validated across multiple independent cohorts, could potentially open doors to new preclinical interventions, lead author Olle Grännö, MD, of Örebro University in Sweden, and colleagues reported. 

“Predictive biomarkers of future clinical onset of active inflammatory bowel disease could detect the disease during ‘a window of opportunity’ when the immune dysregulation is potentially reversible,” the investigators wrote in Gastroenterology.

Preclinical biomarker screening has proven effective in other immune-mediated diseases, such as type 1 diabetes, where risk stratification using autoantibodies enabled early intervention that delayed disease onset, they noted. 

Previous studies suggested similar potential for inflammatory bowel disease (IBD) via predictive autoantibodies and serum proteins, although the accuracy of these markers was not validated in external cohorts. The present study aimed to fill this validation gap.

First, the investigators measured 178 plasma proteins in blood samples taken from 312 individuals before they were diagnosed with IBD. Using machine learning, Dr. Grännö and colleagues compared these findings with blood-matched controls who remained free of IBD through follow-up. This process revealed the 29-protein signature. 

In the same discovery cohort, the panel of 29 proteins differentiated preclinical CD cases from controls with an area under the curve (AUC) of 0.85. The signature was then validated in an independent preclinical cohort of CD patients, with an AUC of 0.87. 

While accuracy increased in proximity to clinical disease onset, the model was still highly predictive up to 16 years before CD diagnosis, at which time the AUC was 0.82. The panel showed perfect performance among newly diagnosed CD patients, with an AUC of 1.0, supporting clinical relevance.

Dr. Olle Grännö (left) and Dr. Jonas Halfvarson are, respectively, the lead and principal authors of a study demonstrating how circulating blood proteins could enable early identification of Crohn's disease.



Predictive power was statistically significant but less compelling among individuals with preclinical ulcerative colitis (UC). In this IBD subgroup, AUC for identification and validation cohorts was 0.77 and 0.67, respectively, while newly diagnosed patients had an AUC of 0.95.

“In preclinical samples, downregulated (but not upregulated) proteins related to gut barrier integrity and macrophage functionality correlated with time to diagnosis of CD,” Dr. Grännö and colleagues wrote. “Contrarily, all proteins associated with preclinical UC were upregulated, and only one protein marker correlated with the time to diagnosis.”

These findings suggest that disruptions in gut barrier integrity and macrophage function precede clinical CD onset, they explained, potentially serving as an early signal of inflammation-driven intestinal damage. In contrast, the preclinical UC signature primarily involved upregulated inflammatory markers.

Dr. Grännö and colleagues also examined the influence of genetic and environmental factors by comparing preclinical IBD signatures in unrelated and related twin pairs. 

The CD biosignature had an AUC of 0.89 when comparing individuals with preclinical CD to matched external (unrelated) healthy twins. Predictive ability dropped significantly (AUC = 0.58) when comparing CD cases to their own healthy twin siblings, suggesting that genetic and shared environmental factors have a “predominant influence” on protein dysregulation. 

In contrast, AUC among unrelated vs related twin controls was more similar for UC, at 0.76 and 0.64, respectively, indicating “a limited impact” of genetic and environmental factors on the protein signature.

Altogether, this study reinforces the concept of a long preclinical phase in CD, and highlights the potential for early detection and intervention, according to the investigators.

“The long preclinical period in CD endorses the adoption of early preventive strategies (e.g., diet alterations and medication) to potentially attenuate disease progression and improve the natural history of CD,” they concluded.

This study was funded by the Swedish Research Council, the Swedish Foundation for Strategic Research, the Örebro University Hospital Research Foundation, and others. The investigators disclosed relationships with Pfizer, Janssen, AbbVie, and others.

Body

Nowadays, preclinical biomarker discovery for inflammatory bowel diseases (IBD) is one of the key areas of study, aiming to identify the earliest stages of disease development and to find opportunities for early intervention. The study by Grännö and colleagues taps into this area and provides a significant advancement in the early detection of Crohn’s disease (CD) with a validated 29-plasma protein biomarker signature.

With an AUC of up to 0.87 in preclinical CD cases and even 0.82 as early as 16 years before diagnosis, these findings strongly support the notion that CD has a prolonged preclinical phase that is detectable up to many years before diagnosis. Importantly, their identified protein signatures also shed light on distinct pathophysiological mechanisms between CD and ulcerative colitis (UC), with CD characterized by early disruptions in gut barrier integrity and macrophage function, while UC was more marked by upregulated inflammatory markers.

For clinical practitioners, these findings have a strong transformative potential. Following further validation in larger cohorts and allowing clinical accessibility, preclinical biomarker screening could become a routine tool for risk stratification in at-risk individuals, such as those with a strong family history or genetic predisposition. This could enable implementation of early interventions, including dietary modifications and potentially prophylactic therapies, to delay or even prevent disease onset. Given that similar approaches have proven effective in type 1 diabetes, applying this strategy to IBD could significantly alter disease progression and patient outcomes.

Challenges remain before implementation in clinical practice could be realized. Standardized thresholds for risk assessment, cost-effectiveness analyses, and potential therapeutic strategies tailored to biomarker-positive individuals require further exploration. However, this study provides important data needed for a paradigm shift in IBD management — one that moves from reactive treatment to proactive prevention.

Arno R. Bourgonje, MD, PhD, is a postdoctoral fellow at the Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, and at the University Medical Center Groningen in Groningen, the Netherlands. He is involved in the European INTERCEPT consortium, which is focused on prediction and prevention of IBD. He reported no conflicts of interest.

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Body

Nowadays, preclinical biomarker discovery for inflammatory bowel diseases (IBD) is one of the key areas of study, aiming to identify the earliest stages of disease development and to find opportunities for early intervention. The study by Grännö and colleagues taps into this area and provides a significant advancement in the early detection of Crohn’s disease (CD) with a validated 29-plasma protein biomarker signature.

With an AUC of up to 0.87 in preclinical CD cases and even 0.82 as early as 16 years before diagnosis, these findings strongly support the notion that CD has a prolonged preclinical phase that is detectable up to many years before diagnosis. Importantly, their identified protein signatures also shed light on distinct pathophysiological mechanisms between CD and ulcerative colitis (UC), with CD characterized by early disruptions in gut barrier integrity and macrophage function, while UC was more marked by upregulated inflammatory markers.

For clinical practitioners, these findings have a strong transformative potential. Following further validation in larger cohorts and allowing clinical accessibility, preclinical biomarker screening could become a routine tool for risk stratification in at-risk individuals, such as those with a strong family history or genetic predisposition. This could enable implementation of early interventions, including dietary modifications and potentially prophylactic therapies, to delay or even prevent disease onset. Given that similar approaches have proven effective in type 1 diabetes, applying this strategy to IBD could significantly alter disease progression and patient outcomes.

Challenges remain before implementation in clinical practice could be realized. Standardized thresholds for risk assessment, cost-effectiveness analyses, and potential therapeutic strategies tailored to biomarker-positive individuals require further exploration. However, this study provides important data needed for a paradigm shift in IBD management — one that moves from reactive treatment to proactive prevention.

Arno R. Bourgonje, MD, PhD, is a postdoctoral fellow at the Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, and at the University Medical Center Groningen in Groningen, the Netherlands. He is involved in the European INTERCEPT consortium, which is focused on prediction and prevention of IBD. He reported no conflicts of interest.

Body

Nowadays, preclinical biomarker discovery for inflammatory bowel diseases (IBD) is one of the key areas of study, aiming to identify the earliest stages of disease development and to find opportunities for early intervention. The study by Grännö and colleagues taps into this area and provides a significant advancement in the early detection of Crohn’s disease (CD) with a validated 29-plasma protein biomarker signature.

With an AUC of up to 0.87 in preclinical CD cases and even 0.82 as early as 16 years before diagnosis, these findings strongly support the notion that CD has a prolonged preclinical phase that is detectable up to many years before diagnosis. Importantly, their identified protein signatures also shed light on distinct pathophysiological mechanisms between CD and ulcerative colitis (UC), with CD characterized by early disruptions in gut barrier integrity and macrophage function, while UC was more marked by upregulated inflammatory markers.

For clinical practitioners, these findings have a strong transformative potential. Following further validation in larger cohorts and allowing clinical accessibility, preclinical biomarker screening could become a routine tool for risk stratification in at-risk individuals, such as those with a strong family history or genetic predisposition. This could enable implementation of early interventions, including dietary modifications and potentially prophylactic therapies, to delay or even prevent disease onset. Given that similar approaches have proven effective in type 1 diabetes, applying this strategy to IBD could significantly alter disease progression and patient outcomes.

Challenges remain before implementation in clinical practice could be realized. Standardized thresholds for risk assessment, cost-effectiveness analyses, and potential therapeutic strategies tailored to biomarker-positive individuals require further exploration. However, this study provides important data needed for a paradigm shift in IBD management — one that moves from reactive treatment to proactive prevention.

Arno R. Bourgonje, MD, PhD, is a postdoctoral fellow at the Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, and at the University Medical Center Groningen in Groningen, the Netherlands. He is involved in the European INTERCEPT consortium, which is focused on prediction and prevention of IBD. He reported no conflicts of interest.

Title
From Treatment to Prevention
From Treatment to Prevention

Circulating blood proteins could enable early identification of Crohn’s disease (CD) years before clinical signs, according to investigators.

The 29-protein biosignature, which was validated across multiple independent cohorts, could potentially open doors to new preclinical interventions, lead author Olle Grännö, MD, of Örebro University in Sweden, and colleagues reported. 

“Predictive biomarkers of future clinical onset of active inflammatory bowel disease could detect the disease during ‘a window of opportunity’ when the immune dysregulation is potentially reversible,” the investigators wrote in Gastroenterology.

Preclinical biomarker screening has proven effective in other immune-mediated diseases, such as type 1 diabetes, where risk stratification using autoantibodies enabled early intervention that delayed disease onset, they noted. 

Previous studies suggested similar potential for inflammatory bowel disease (IBD) via predictive autoantibodies and serum proteins, although the accuracy of these markers was not validated in external cohorts. The present study aimed to fill this validation gap.

First, the investigators measured 178 plasma proteins in blood samples taken from 312 individuals before they were diagnosed with IBD. Using machine learning, Dr. Grännö and colleagues compared these findings with blood-matched controls who remained free of IBD through follow-up. This process revealed the 29-protein signature. 

In the same discovery cohort, the panel of 29 proteins differentiated preclinical CD cases from controls with an area under the curve (AUC) of 0.85. The signature was then validated in an independent preclinical cohort of CD patients, with an AUC of 0.87. 

While accuracy increased in proximity to clinical disease onset, the model was still highly predictive up to 16 years before CD diagnosis, at which time the AUC was 0.82. The panel showed perfect performance among newly diagnosed CD patients, with an AUC of 1.0, supporting clinical relevance.

Dr. Olle Grännö (left) and Dr. Jonas Halfvarson are, respectively, the lead and principal authors of a study demonstrating how circulating blood proteins could enable early identification of Crohn's disease.



Predictive power was statistically significant but less compelling among individuals with preclinical ulcerative colitis (UC). In this IBD subgroup, AUC for identification and validation cohorts was 0.77 and 0.67, respectively, while newly diagnosed patients had an AUC of 0.95.

“In preclinical samples, downregulated (but not upregulated) proteins related to gut barrier integrity and macrophage functionality correlated with time to diagnosis of CD,” Dr. Grännö and colleagues wrote. “Contrarily, all proteins associated with preclinical UC were upregulated, and only one protein marker correlated with the time to diagnosis.”

These findings suggest that disruptions in gut barrier integrity and macrophage function precede clinical CD onset, they explained, potentially serving as an early signal of inflammation-driven intestinal damage. In contrast, the preclinical UC signature primarily involved upregulated inflammatory markers.

Dr. Grännö and colleagues also examined the influence of genetic and environmental factors by comparing preclinical IBD signatures in unrelated and related twin pairs. 

The CD biosignature had an AUC of 0.89 when comparing individuals with preclinical CD to matched external (unrelated) healthy twins. Predictive ability dropped significantly (AUC = 0.58) when comparing CD cases to their own healthy twin siblings, suggesting that genetic and shared environmental factors have a “predominant influence” on protein dysregulation. 

In contrast, AUC among unrelated vs related twin controls was more similar for UC, at 0.76 and 0.64, respectively, indicating “a limited impact” of genetic and environmental factors on the protein signature.

Altogether, this study reinforces the concept of a long preclinical phase in CD, and highlights the potential for early detection and intervention, according to the investigators.

“The long preclinical period in CD endorses the adoption of early preventive strategies (e.g., diet alterations and medication) to potentially attenuate disease progression and improve the natural history of CD,” they concluded.

This study was funded by the Swedish Research Council, the Swedish Foundation for Strategic Research, the Örebro University Hospital Research Foundation, and others. The investigators disclosed relationships with Pfizer, Janssen, AbbVie, and others.

Circulating blood proteins could enable early identification of Crohn’s disease (CD) years before clinical signs, according to investigators.

The 29-protein biosignature, which was validated across multiple independent cohorts, could potentially open doors to new preclinical interventions, lead author Olle Grännö, MD, of Örebro University in Sweden, and colleagues reported. 

“Predictive biomarkers of future clinical onset of active inflammatory bowel disease could detect the disease during ‘a window of opportunity’ when the immune dysregulation is potentially reversible,” the investigators wrote in Gastroenterology.

Preclinical biomarker screening has proven effective in other immune-mediated diseases, such as type 1 diabetes, where risk stratification using autoantibodies enabled early intervention that delayed disease onset, they noted. 

Previous studies suggested similar potential for inflammatory bowel disease (IBD) via predictive autoantibodies and serum proteins, although the accuracy of these markers was not validated in external cohorts. The present study aimed to fill this validation gap.

First, the investigators measured 178 plasma proteins in blood samples taken from 312 individuals before they were diagnosed with IBD. Using machine learning, Dr. Grännö and colleagues compared these findings with blood-matched controls who remained free of IBD through follow-up. This process revealed the 29-protein signature. 

In the same discovery cohort, the panel of 29 proteins differentiated preclinical CD cases from controls with an area under the curve (AUC) of 0.85. The signature was then validated in an independent preclinical cohort of CD patients, with an AUC of 0.87. 

While accuracy increased in proximity to clinical disease onset, the model was still highly predictive up to 16 years before CD diagnosis, at which time the AUC was 0.82. The panel showed perfect performance among newly diagnosed CD patients, with an AUC of 1.0, supporting clinical relevance.

Dr. Olle Grännö (left) and Dr. Jonas Halfvarson are, respectively, the lead and principal authors of a study demonstrating how circulating blood proteins could enable early identification of Crohn's disease.



Predictive power was statistically significant but less compelling among individuals with preclinical ulcerative colitis (UC). In this IBD subgroup, AUC for identification and validation cohorts was 0.77 and 0.67, respectively, while newly diagnosed patients had an AUC of 0.95.

“In preclinical samples, downregulated (but not upregulated) proteins related to gut barrier integrity and macrophage functionality correlated with time to diagnosis of CD,” Dr. Grännö and colleagues wrote. “Contrarily, all proteins associated with preclinical UC were upregulated, and only one protein marker correlated with the time to diagnosis.”

These findings suggest that disruptions in gut barrier integrity and macrophage function precede clinical CD onset, they explained, potentially serving as an early signal of inflammation-driven intestinal damage. In contrast, the preclinical UC signature primarily involved upregulated inflammatory markers.

Dr. Grännö and colleagues also examined the influence of genetic and environmental factors by comparing preclinical IBD signatures in unrelated and related twin pairs. 

The CD biosignature had an AUC of 0.89 when comparing individuals with preclinical CD to matched external (unrelated) healthy twins. Predictive ability dropped significantly (AUC = 0.58) when comparing CD cases to their own healthy twin siblings, suggesting that genetic and shared environmental factors have a “predominant influence” on protein dysregulation. 

In contrast, AUC among unrelated vs related twin controls was more similar for UC, at 0.76 and 0.64, respectively, indicating “a limited impact” of genetic and environmental factors on the protein signature.

Altogether, this study reinforces the concept of a long preclinical phase in CD, and highlights the potential for early detection and intervention, according to the investigators.

“The long preclinical period in CD endorses the adoption of early preventive strategies (e.g., diet alterations and medication) to potentially attenuate disease progression and improve the natural history of CD,” they concluded.

This study was funded by the Swedish Research Council, the Swedish Foundation for Strategic Research, the Örebro University Hospital Research Foundation, and others. The investigators disclosed relationships with Pfizer, Janssen, AbbVie, and others.

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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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Where Are All the Nurses? Data Show That Some States Have a Far Higher Number of Nurses Per Capita Than Others

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During their 12-hour shifts, registered nurses (RNs) in Arizona and Arkansas perform many of the same tasks as RNs in Wisconsin and Wyoming: Assessing patients, monitoring vital signs, administering medications, and charting records to provide the best patient care. The work might be similar, but there are vast differences in the number of RNs in each state.

In states like Idaho, Utah, and Nevada, which have the lowest number of nurses per capita, there are as few as 7 nurses per 1000 residents, compared with South Dakota and the District of Columbia, which have double the number of nurses than underserved states — giving them the highest number of nurses per capita.

Even states with the largest number of nurses per capita are not immune to the nursing shortage. The National Bureau of Labor Statistics estimates that there will be 195,400 job openings for RNs from 2021 to 2031.

So, what makes it easier for some states to recruit and retain RNs than others?

 

States With the Highest Number of Nurses Per Capita

South Dakota

RNs per 1000 residents: 15.79

Average wage: $67,030 or $32.23 per hour

Average rent in Sioux Falls: $1192 per month

The Midwestern state has more miles of shoreline than Florida, herds of wild buffalo, the highest summit east of the Rockies, and more nurses per capita than all other states . Healthcare is one of the major industries in the Mount Rushmore State.

Haifa Abou Samra, dean and professor at the University of South Dakota School of Health Sciences, Vermillion, isn’t surprised that RNs want to call the state home. 

“South Dakota is a nice place to live,” Samra said. “[The] schools are wonderful. If people are growing families, there is support; neighbors support their neighbors, and it’s a relatively safe community.”

South Dakota has 19 approved nursing education programs that graduated 878 RNs in 2022. Scholarships and student loan forgiveness programs have helped attract qualified RNs, and collaborations between education and industry have been instrumental in addressing the nursing shortage, Samra told this news organization.

Even though RNs earn less than the median wage ($87,070 per year/41.38 per hour), South Dakota has a low cost of living and no individual income tax, which helps stretch those earnings.

 

District of Columbia

RNs per 1000 residents: 15.39

Average wage: $105,220 or $50.59 per hour

Average rent in Washington, DC: $2485 per month

After a shift at some of the top-ranking hospitals in the nation, RNs working in the compact capital region can explore museums, monuments, and cultural sites; walk along the banks of the Potomac River; or grab a bite at award-winning restaurants.

Washington, a top-ranking metro area because of its growth, high wages, and access to economic opportunities, is also home to several top-tier hospitals and some of the best healthcare in the nation, and RNs who want to pursue continuing education have access to top-tier universities.

Nurses in Washington, DC, might make some of the highest wages in the nation, but the region also has the second-highest cost of living in the United States, with average rents topping $2400 per month and an average home price of $594,337.

 

North Dakota

RNs per 1000 residents: 12.99

Average wage: $74,930 or $36.03 per hour

Average rent in Fargo: $1051 per month

North Dakota projects a 10.4% increase in employment for RNs, which is higher than the national average, and the state has implemented several strategies to address chronic nursing shortages. The Nurse Staffing Clearinghouse connects nursing school graduates with local employers and created a statewide nursing staffing pool for in-state recruitment of travel nurses.

But it’s not just plentiful job opportunities and a low cost of living that attract nurses to the Peace Garden State. The state and its largest cities, Bismarck and Fargo, hold several “best of” accolades, including nods for the safest places to live and among the Best Places to Raise a Family, giving it high marks for quality of life.

Sure, the winters are cold, but the outdoor recreation can’t be beaten. RNs can bundle up and see the bighorn sheep in the Badlands at Theodore Roosevelt National Park or explore expansive terrain for skiing, snowboarding, and snowmobile trails.

 

States With the Lowest Number of Nurses Per Capita

Nevada

RNs per 1000 residents: 7.92

Average wage: $96,201 or $46.25 per hour

Average rent in Las Vegas: $1478 per month

Despite a projected 23% job growth for RNs between 2020 and 2030, the state has struggled to fill open positions. It might be the higher-than-average cost of living (9.7% higher than the US average) or higher-than-average crime rates that make RNs reluctant to gamble on a job in the Silver State. But there are some big wins for nurses in the state.

Salaries are higher than the national average, there is no state income tax, and some of the lowest property taxes in the nation. Thanks to new legislation, RNs with student loan debt won’t have to bet on black at the casino to make their payments. The Health Equity and Loan Assistance Program is a new initiative that offers up to $120,000 in loan repayment assistance to providers, including RNs, who commit to working in underserved and rural areas across the state for 5 years.

The state also has incredible attractions, from the neon lights and over-the-top architecture in Las Vegas to iconic red rock canyons, stunning state parks, and landmarks like Hoover Dam and Lake Tahoe.

 

Utah

RNs per 1000 residents: 7.05

Average wage: $79,790 or $38.36 per hour

Average rent in Salt Lake City: $1611 per month

Healthcare is one of the biggest employers in Utah, and nurses are the most in-demand healthcare workers in the state. But below-average wages and a cost of living that is a whopping 28% higher than the national average could be some reasons that the Beehive State is struggling to attract nurses.

A high number of job vacancies mean higher patient-to-nurse ratios, creating additional stress for a workforce prone to burnout. Much of the state is rural, public transportation is inadequate, and poor air quality causes frequent haze and smog.

The challenges are offset by some big benefits: Utah has been ranked as the “best state” thanks to the strong economy, infrastructure, and quality education — and it doesn’t hurt that Utah is home to myriad outdoor recreation opportunities and the stunning scenery at landmarks like Bryce Canyon and Arches National Park.

Moreover, Utah is hustling to boost its RN workforce. The University of Utah, Salt Lake City, has increased enrollment by 25% and hired additional faculty to help boost the nursing workforce — and those who work in hospitals and health clinics across the state benefit from a flat 4.55% individual income tax rate.

 

Idaho

RNs per 1000 residents: 7.02

Average wage: $80,130 or $38.53 per hour

Average rent in Boise: $1646 per month

Although the nursing workforce in Idaho has increased, it still ranks as the lowest in the nation. Teresa Stanfill, DNP, RN, executive director for the Idaho Center for Nursing, said that the number of new nurses is too low to replace the number of retiring nurses.

The state introduced loan repayment programs that award up to $25,000 to cover student loan debt, and hospitals and health systems often offer sign-on bonuses and relocation packages to attract RNs. But long winters, an isolated location, and limited cultural options can make it harder to attract nurses to the state.

It’s easier to recruit RNs to suburban areas like Boise, Meridian, and Nampa, but rural parts of the state struggle, Stanfill added. The nursing shortage is among the reasons that 11 hospitals and emergency departments closed in 2024, and healthcare organizations slashed services across the state.

Idaho has a lot to offer RNs, from small-town charm, reasonable cost of living, and gorgeous landscapes that make it one of the top 10 fastest-growing states in the nation. Collaboration between industry leaders and nursing programs is focused on finding creative solutions to boost the nursing workforce in Idaho.

A version of this article first appeared on Medscape.com.

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During their 12-hour shifts, registered nurses (RNs) in Arizona and Arkansas perform many of the same tasks as RNs in Wisconsin and Wyoming: Assessing patients, monitoring vital signs, administering medications, and charting records to provide the best patient care. The work might be similar, but there are vast differences in the number of RNs in each state.

In states like Idaho, Utah, and Nevada, which have the lowest number of nurses per capita, there are as few as 7 nurses per 1000 residents, compared with South Dakota and the District of Columbia, which have double the number of nurses than underserved states — giving them the highest number of nurses per capita.

Even states with the largest number of nurses per capita are not immune to the nursing shortage. The National Bureau of Labor Statistics estimates that there will be 195,400 job openings for RNs from 2021 to 2031.

So, what makes it easier for some states to recruit and retain RNs than others?

 

States With the Highest Number of Nurses Per Capita

South Dakota

RNs per 1000 residents: 15.79

Average wage: $67,030 or $32.23 per hour

Average rent in Sioux Falls: $1192 per month

The Midwestern state has more miles of shoreline than Florida, herds of wild buffalo, the highest summit east of the Rockies, and more nurses per capita than all other states . Healthcare is one of the major industries in the Mount Rushmore State.

Haifa Abou Samra, dean and professor at the University of South Dakota School of Health Sciences, Vermillion, isn’t surprised that RNs want to call the state home. 

“South Dakota is a nice place to live,” Samra said. “[The] schools are wonderful. If people are growing families, there is support; neighbors support their neighbors, and it’s a relatively safe community.”

South Dakota has 19 approved nursing education programs that graduated 878 RNs in 2022. Scholarships and student loan forgiveness programs have helped attract qualified RNs, and collaborations between education and industry have been instrumental in addressing the nursing shortage, Samra told this news organization.

Even though RNs earn less than the median wage ($87,070 per year/41.38 per hour), South Dakota has a low cost of living and no individual income tax, which helps stretch those earnings.

 

District of Columbia

RNs per 1000 residents: 15.39

Average wage: $105,220 or $50.59 per hour

Average rent in Washington, DC: $2485 per month

After a shift at some of the top-ranking hospitals in the nation, RNs working in the compact capital region can explore museums, monuments, and cultural sites; walk along the banks of the Potomac River; or grab a bite at award-winning restaurants.

Washington, a top-ranking metro area because of its growth, high wages, and access to economic opportunities, is also home to several top-tier hospitals and some of the best healthcare in the nation, and RNs who want to pursue continuing education have access to top-tier universities.

Nurses in Washington, DC, might make some of the highest wages in the nation, but the region also has the second-highest cost of living in the United States, with average rents topping $2400 per month and an average home price of $594,337.

 

North Dakota

RNs per 1000 residents: 12.99

Average wage: $74,930 or $36.03 per hour

Average rent in Fargo: $1051 per month

North Dakota projects a 10.4% increase in employment for RNs, which is higher than the national average, and the state has implemented several strategies to address chronic nursing shortages. The Nurse Staffing Clearinghouse connects nursing school graduates with local employers and created a statewide nursing staffing pool for in-state recruitment of travel nurses.

But it’s not just plentiful job opportunities and a low cost of living that attract nurses to the Peace Garden State. The state and its largest cities, Bismarck and Fargo, hold several “best of” accolades, including nods for the safest places to live and among the Best Places to Raise a Family, giving it high marks for quality of life.

Sure, the winters are cold, but the outdoor recreation can’t be beaten. RNs can bundle up and see the bighorn sheep in the Badlands at Theodore Roosevelt National Park or explore expansive terrain for skiing, snowboarding, and snowmobile trails.

 

States With the Lowest Number of Nurses Per Capita

Nevada

RNs per 1000 residents: 7.92

Average wage: $96,201 or $46.25 per hour

Average rent in Las Vegas: $1478 per month

Despite a projected 23% job growth for RNs between 2020 and 2030, the state has struggled to fill open positions. It might be the higher-than-average cost of living (9.7% higher than the US average) or higher-than-average crime rates that make RNs reluctant to gamble on a job in the Silver State. But there are some big wins for nurses in the state.

Salaries are higher than the national average, there is no state income tax, and some of the lowest property taxes in the nation. Thanks to new legislation, RNs with student loan debt won’t have to bet on black at the casino to make their payments. The Health Equity and Loan Assistance Program is a new initiative that offers up to $120,000 in loan repayment assistance to providers, including RNs, who commit to working in underserved and rural areas across the state for 5 years.

The state also has incredible attractions, from the neon lights and over-the-top architecture in Las Vegas to iconic red rock canyons, stunning state parks, and landmarks like Hoover Dam and Lake Tahoe.

 

Utah

RNs per 1000 residents: 7.05

Average wage: $79,790 or $38.36 per hour

Average rent in Salt Lake City: $1611 per month

Healthcare is one of the biggest employers in Utah, and nurses are the most in-demand healthcare workers in the state. But below-average wages and a cost of living that is a whopping 28% higher than the national average could be some reasons that the Beehive State is struggling to attract nurses.

A high number of job vacancies mean higher patient-to-nurse ratios, creating additional stress for a workforce prone to burnout. Much of the state is rural, public transportation is inadequate, and poor air quality causes frequent haze and smog.

The challenges are offset by some big benefits: Utah has been ranked as the “best state” thanks to the strong economy, infrastructure, and quality education — and it doesn’t hurt that Utah is home to myriad outdoor recreation opportunities and the stunning scenery at landmarks like Bryce Canyon and Arches National Park.

Moreover, Utah is hustling to boost its RN workforce. The University of Utah, Salt Lake City, has increased enrollment by 25% and hired additional faculty to help boost the nursing workforce — and those who work in hospitals and health clinics across the state benefit from a flat 4.55% individual income tax rate.

 

Idaho

RNs per 1000 residents: 7.02

Average wage: $80,130 or $38.53 per hour

Average rent in Boise: $1646 per month

Although the nursing workforce in Idaho has increased, it still ranks as the lowest in the nation. Teresa Stanfill, DNP, RN, executive director for the Idaho Center for Nursing, said that the number of new nurses is too low to replace the number of retiring nurses.

The state introduced loan repayment programs that award up to $25,000 to cover student loan debt, and hospitals and health systems often offer sign-on bonuses and relocation packages to attract RNs. But long winters, an isolated location, and limited cultural options can make it harder to attract nurses to the state.

It’s easier to recruit RNs to suburban areas like Boise, Meridian, and Nampa, but rural parts of the state struggle, Stanfill added. The nursing shortage is among the reasons that 11 hospitals and emergency departments closed in 2024, and healthcare organizations slashed services across the state.

Idaho has a lot to offer RNs, from small-town charm, reasonable cost of living, and gorgeous landscapes that make it one of the top 10 fastest-growing states in the nation. Collaboration between industry leaders and nursing programs is focused on finding creative solutions to boost the nursing workforce in Idaho.

A version of this article first appeared on Medscape.com.

During their 12-hour shifts, registered nurses (RNs) in Arizona and Arkansas perform many of the same tasks as RNs in Wisconsin and Wyoming: Assessing patients, monitoring vital signs, administering medications, and charting records to provide the best patient care. The work might be similar, but there are vast differences in the number of RNs in each state.

In states like Idaho, Utah, and Nevada, which have the lowest number of nurses per capita, there are as few as 7 nurses per 1000 residents, compared with South Dakota and the District of Columbia, which have double the number of nurses than underserved states — giving them the highest number of nurses per capita.

Even states with the largest number of nurses per capita are not immune to the nursing shortage. The National Bureau of Labor Statistics estimates that there will be 195,400 job openings for RNs from 2021 to 2031.

So, what makes it easier for some states to recruit and retain RNs than others?

 

States With the Highest Number of Nurses Per Capita

South Dakota

RNs per 1000 residents: 15.79

Average wage: $67,030 or $32.23 per hour

Average rent in Sioux Falls: $1192 per month

The Midwestern state has more miles of shoreline than Florida, herds of wild buffalo, the highest summit east of the Rockies, and more nurses per capita than all other states . Healthcare is one of the major industries in the Mount Rushmore State.

Haifa Abou Samra, dean and professor at the University of South Dakota School of Health Sciences, Vermillion, isn’t surprised that RNs want to call the state home. 

“South Dakota is a nice place to live,” Samra said. “[The] schools are wonderful. If people are growing families, there is support; neighbors support their neighbors, and it’s a relatively safe community.”

South Dakota has 19 approved nursing education programs that graduated 878 RNs in 2022. Scholarships and student loan forgiveness programs have helped attract qualified RNs, and collaborations between education and industry have been instrumental in addressing the nursing shortage, Samra told this news organization.

Even though RNs earn less than the median wage ($87,070 per year/41.38 per hour), South Dakota has a low cost of living and no individual income tax, which helps stretch those earnings.

 

District of Columbia

RNs per 1000 residents: 15.39

Average wage: $105,220 or $50.59 per hour

Average rent in Washington, DC: $2485 per month

After a shift at some of the top-ranking hospitals in the nation, RNs working in the compact capital region can explore museums, monuments, and cultural sites; walk along the banks of the Potomac River; or grab a bite at award-winning restaurants.

Washington, a top-ranking metro area because of its growth, high wages, and access to economic opportunities, is also home to several top-tier hospitals and some of the best healthcare in the nation, and RNs who want to pursue continuing education have access to top-tier universities.

Nurses in Washington, DC, might make some of the highest wages in the nation, but the region also has the second-highest cost of living in the United States, with average rents topping $2400 per month and an average home price of $594,337.

 

North Dakota

RNs per 1000 residents: 12.99

Average wage: $74,930 or $36.03 per hour

Average rent in Fargo: $1051 per month

North Dakota projects a 10.4% increase in employment for RNs, which is higher than the national average, and the state has implemented several strategies to address chronic nursing shortages. The Nurse Staffing Clearinghouse connects nursing school graduates with local employers and created a statewide nursing staffing pool for in-state recruitment of travel nurses.

But it’s not just plentiful job opportunities and a low cost of living that attract nurses to the Peace Garden State. The state and its largest cities, Bismarck and Fargo, hold several “best of” accolades, including nods for the safest places to live and among the Best Places to Raise a Family, giving it high marks for quality of life.

Sure, the winters are cold, but the outdoor recreation can’t be beaten. RNs can bundle up and see the bighorn sheep in the Badlands at Theodore Roosevelt National Park or explore expansive terrain for skiing, snowboarding, and snowmobile trails.

 

States With the Lowest Number of Nurses Per Capita

Nevada

RNs per 1000 residents: 7.92

Average wage: $96,201 or $46.25 per hour

Average rent in Las Vegas: $1478 per month

Despite a projected 23% job growth for RNs between 2020 and 2030, the state has struggled to fill open positions. It might be the higher-than-average cost of living (9.7% higher than the US average) or higher-than-average crime rates that make RNs reluctant to gamble on a job in the Silver State. But there are some big wins for nurses in the state.

Salaries are higher than the national average, there is no state income tax, and some of the lowest property taxes in the nation. Thanks to new legislation, RNs with student loan debt won’t have to bet on black at the casino to make their payments. The Health Equity and Loan Assistance Program is a new initiative that offers up to $120,000 in loan repayment assistance to providers, including RNs, who commit to working in underserved and rural areas across the state for 5 years.

The state also has incredible attractions, from the neon lights and over-the-top architecture in Las Vegas to iconic red rock canyons, stunning state parks, and landmarks like Hoover Dam and Lake Tahoe.

 

Utah

RNs per 1000 residents: 7.05

Average wage: $79,790 or $38.36 per hour

Average rent in Salt Lake City: $1611 per month

Healthcare is one of the biggest employers in Utah, and nurses are the most in-demand healthcare workers in the state. But below-average wages and a cost of living that is a whopping 28% higher than the national average could be some reasons that the Beehive State is struggling to attract nurses.

A high number of job vacancies mean higher patient-to-nurse ratios, creating additional stress for a workforce prone to burnout. Much of the state is rural, public transportation is inadequate, and poor air quality causes frequent haze and smog.

The challenges are offset by some big benefits: Utah has been ranked as the “best state” thanks to the strong economy, infrastructure, and quality education — and it doesn’t hurt that Utah is home to myriad outdoor recreation opportunities and the stunning scenery at landmarks like Bryce Canyon and Arches National Park.

Moreover, Utah is hustling to boost its RN workforce. The University of Utah, Salt Lake City, has increased enrollment by 25% and hired additional faculty to help boost the nursing workforce — and those who work in hospitals and health clinics across the state benefit from a flat 4.55% individual income tax rate.

 

Idaho

RNs per 1000 residents: 7.02

Average wage: $80,130 or $38.53 per hour

Average rent in Boise: $1646 per month

Although the nursing workforce in Idaho has increased, it still ranks as the lowest in the nation. Teresa Stanfill, DNP, RN, executive director for the Idaho Center for Nursing, said that the number of new nurses is too low to replace the number of retiring nurses.

The state introduced loan repayment programs that award up to $25,000 to cover student loan debt, and hospitals and health systems often offer sign-on bonuses and relocation packages to attract RNs. But long winters, an isolated location, and limited cultural options can make it harder to attract nurses to the state.

It’s easier to recruit RNs to suburban areas like Boise, Meridian, and Nampa, but rural parts of the state struggle, Stanfill added. The nursing shortage is among the reasons that 11 hospitals and emergency departments closed in 2024, and healthcare organizations slashed services across the state.

Idaho has a lot to offer RNs, from small-town charm, reasonable cost of living, and gorgeous landscapes that make it one of the top 10 fastest-growing states in the nation. Collaboration between industry leaders and nursing programs is focused on finding creative solutions to boost the nursing workforce in Idaho.

A version of this article first appeared on Medscape.com.

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Bariatric Surgery: Nutrition’s Role in Patient Outcomes

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Perioperative optimization of nutrition leads to lower risks, better outcomes, and improved quality of life for adult patients undergoing metabolic and bariatric surgery, according to an updated clinical practice statement from the Obesity Medicine Association (OMA).

The update offers guidance on how to manage metabolic and bariatric surgery patients’ nutrition, from preoperative nutritional assessments through identification and treatment of the most common nutritional problems associated with bariatric procedures.

“The main takeaway really is that obesity is a complex and chronic disease. It requires the same model of care as diabetes or other chronic conditions,” said Rutuja Patel, DO, senior author and an obesity medicine specialist at Northwestern Medicine Regional Medical Group in Winfield, Illinois.

The development of an interdisciplinary team of medical providers with evidence-based nutrition knowledge and consistent information improves the quality of nutrition care provided to bariatric surgery patients, the authors wrote.

“Collaborative multidisciplinary care that takes into consideration the whole patient in a biopsychosocial way and uses multiple modalities — including medical, behavioral, nutritional, and others — leads to the best outcomes in these complex patients,” Patel said.

The updated statement, published online in Obesity Pillars, offers a variety of tools and checklists to aid clinicians, especially those who may not have access to a multidisciplinary team or dietitian knowledgeable about bariatric nutrition.

It is a follow-up to the OMA’s 2022 clinical practice statement, which provided an overview of bariatric surgery, gastrointestinal hormones, and the microbiome in patients with obesity.

 

Presurgical Guidance

The new guidance lays out the various components of preoperative nutrition screenings, among which is a medication review to determine if the patient is taking drugs that may affect weight and calorie intake. These include antihypertensives, diabetes agents, hormonal contraceptives, antidepressants, migraine medications, and antipsychotics.

In taking a patient’s history, clinicians should ask about major events associated with weight changes, such as medication changes, illness, pregnancy, divorce, stressful employment, food insecurity, and periods of disordered eating.

The fundamental approach to conducting a nutrition assessment is an understanding of the role that various sections of the gastrointestinal tract play in micronutrient absorption, the authors wrote. As an educational tool, the update includes a diagram that indicates the areas of the stomach, duodenum, jejunum, and ileum that may be altered by bariatric surgery and how they factor into micronutrient absorption.

“It makes it easier to see why certain surgical procedures are more likely to cause certain deficiencies,” Patel said.

 

Postsurgery Patient Management

Post surgery, clinicians should monitor patients for other problems that could affect nutrient absorption, including food intolerances, drug-nutrient interactions, and increased gastrointestinal transit time.

Patel and coauthors discussed the pros and cons of multivitamin mineral supplement formulations as well as specific vitamin and mineral recommendations for patients undergoing certain metabolic or bariatric surgery procedures. They included three supplemental cases in the appendix to illustrate supplementation recommendations and long-term maintenance suggestions.

“It’s important to remember that most of these deficiencies present without many clinical symptoms, so it becomes essential to screen for them and repeat as needed,” Patel said.

The update also tackles postoperative nutritional assessments and diet progression. No evidence supports following one postsurgical diet progression protocol over another, but they generally proceed from a clear liquid diet to foods with normal textures, the authors noted. Clinicians should adapt them according to the procedure type, they added.

In addition, clinicians must troubleshoot any nutrition-related concerns, including constipation, dehydration, nausea, heartburn, and fatigue, for up to a year after surgery, they wrote.

Metabolic and bariatric surgery patients should be evaluated annually at a minimum, if not more frequently, to gauge nutritional health, the authors wrote. Treating obesity as a disease involves more than weight loss — instead, it’s about improving the quality of life of patients through procedures, medications, and lifestyle modifications, they added.

 

Track New Developments

With ongoing changes in the field of metabolic and bariatric surgery, it’s helpful for clinicians to remain updated about new approaches across various disciplines linked to obesity management and treatment, said Christina Poa-Li, MD, a surgeon at Huntington Health Medical Center, affiliated with Cedars-Sinai Health System, in Pasadena, California, who was not involved in developing the updated practice statement.

“For example, the rapidly growing prescription of anti-obesity medications and their use in both preoperative and postoperative surgical patients drastically affect their nutrition,” she said. “Providers of various backgrounds and specialties will benefit from the most updated guidance on evaluating patient nutrition.”

Clinicians should consider expanding their patient population to include those with metabolic dysfunction–associated steatohepatitis or metabolic dysfunction–associated steatotic liver disease, Poa-Li said.

“These patient subpopulations may not have been considered for bariatric surgery or even referral to a bariatric surgeon for consultation previously,” she said. “It is important to increase awareness among clinicians of the potential benefits for metabolic and bariatric surgery for these patients.”

The report didn’t receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Patel and Poa-Li reported no relevant disclosures.

A version of this article appeared on Medscape.com.

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Perioperative optimization of nutrition leads to lower risks, better outcomes, and improved quality of life for adult patients undergoing metabolic and bariatric surgery, according to an updated clinical practice statement from the Obesity Medicine Association (OMA).

The update offers guidance on how to manage metabolic and bariatric surgery patients’ nutrition, from preoperative nutritional assessments through identification and treatment of the most common nutritional problems associated with bariatric procedures.

“The main takeaway really is that obesity is a complex and chronic disease. It requires the same model of care as diabetes or other chronic conditions,” said Rutuja Patel, DO, senior author and an obesity medicine specialist at Northwestern Medicine Regional Medical Group in Winfield, Illinois.

The development of an interdisciplinary team of medical providers with evidence-based nutrition knowledge and consistent information improves the quality of nutrition care provided to bariatric surgery patients, the authors wrote.

“Collaborative multidisciplinary care that takes into consideration the whole patient in a biopsychosocial way and uses multiple modalities — including medical, behavioral, nutritional, and others — leads to the best outcomes in these complex patients,” Patel said.

The updated statement, published online in Obesity Pillars, offers a variety of tools and checklists to aid clinicians, especially those who may not have access to a multidisciplinary team or dietitian knowledgeable about bariatric nutrition.

It is a follow-up to the OMA’s 2022 clinical practice statement, which provided an overview of bariatric surgery, gastrointestinal hormones, and the microbiome in patients with obesity.

 

Presurgical Guidance

The new guidance lays out the various components of preoperative nutrition screenings, among which is a medication review to determine if the patient is taking drugs that may affect weight and calorie intake. These include antihypertensives, diabetes agents, hormonal contraceptives, antidepressants, migraine medications, and antipsychotics.

In taking a patient’s history, clinicians should ask about major events associated with weight changes, such as medication changes, illness, pregnancy, divorce, stressful employment, food insecurity, and periods of disordered eating.

The fundamental approach to conducting a nutrition assessment is an understanding of the role that various sections of the gastrointestinal tract play in micronutrient absorption, the authors wrote. As an educational tool, the update includes a diagram that indicates the areas of the stomach, duodenum, jejunum, and ileum that may be altered by bariatric surgery and how they factor into micronutrient absorption.

“It makes it easier to see why certain surgical procedures are more likely to cause certain deficiencies,” Patel said.

 

Postsurgery Patient Management

Post surgery, clinicians should monitor patients for other problems that could affect nutrient absorption, including food intolerances, drug-nutrient interactions, and increased gastrointestinal transit time.

Patel and coauthors discussed the pros and cons of multivitamin mineral supplement formulations as well as specific vitamin and mineral recommendations for patients undergoing certain metabolic or bariatric surgery procedures. They included three supplemental cases in the appendix to illustrate supplementation recommendations and long-term maintenance suggestions.

“It’s important to remember that most of these deficiencies present without many clinical symptoms, so it becomes essential to screen for them and repeat as needed,” Patel said.

The update also tackles postoperative nutritional assessments and diet progression. No evidence supports following one postsurgical diet progression protocol over another, but they generally proceed from a clear liquid diet to foods with normal textures, the authors noted. Clinicians should adapt them according to the procedure type, they added.

In addition, clinicians must troubleshoot any nutrition-related concerns, including constipation, dehydration, nausea, heartburn, and fatigue, for up to a year after surgery, they wrote.

Metabolic and bariatric surgery patients should be evaluated annually at a minimum, if not more frequently, to gauge nutritional health, the authors wrote. Treating obesity as a disease involves more than weight loss — instead, it’s about improving the quality of life of patients through procedures, medications, and lifestyle modifications, they added.

 

Track New Developments

With ongoing changes in the field of metabolic and bariatric surgery, it’s helpful for clinicians to remain updated about new approaches across various disciplines linked to obesity management and treatment, said Christina Poa-Li, MD, a surgeon at Huntington Health Medical Center, affiliated with Cedars-Sinai Health System, in Pasadena, California, who was not involved in developing the updated practice statement.

“For example, the rapidly growing prescription of anti-obesity medications and their use in both preoperative and postoperative surgical patients drastically affect their nutrition,” she said. “Providers of various backgrounds and specialties will benefit from the most updated guidance on evaluating patient nutrition.”

Clinicians should consider expanding their patient population to include those with metabolic dysfunction–associated steatohepatitis or metabolic dysfunction–associated steatotic liver disease, Poa-Li said.

“These patient subpopulations may not have been considered for bariatric surgery or even referral to a bariatric surgeon for consultation previously,” she said. “It is important to increase awareness among clinicians of the potential benefits for metabolic and bariatric surgery for these patients.”

The report didn’t receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Patel and Poa-Li reported no relevant disclosures.

A version of this article appeared on Medscape.com.

Perioperative optimization of nutrition leads to lower risks, better outcomes, and improved quality of life for adult patients undergoing metabolic and bariatric surgery, according to an updated clinical practice statement from the Obesity Medicine Association (OMA).

The update offers guidance on how to manage metabolic and bariatric surgery patients’ nutrition, from preoperative nutritional assessments through identification and treatment of the most common nutritional problems associated with bariatric procedures.

“The main takeaway really is that obesity is a complex and chronic disease. It requires the same model of care as diabetes or other chronic conditions,” said Rutuja Patel, DO, senior author and an obesity medicine specialist at Northwestern Medicine Regional Medical Group in Winfield, Illinois.

The development of an interdisciplinary team of medical providers with evidence-based nutrition knowledge and consistent information improves the quality of nutrition care provided to bariatric surgery patients, the authors wrote.

“Collaborative multidisciplinary care that takes into consideration the whole patient in a biopsychosocial way and uses multiple modalities — including medical, behavioral, nutritional, and others — leads to the best outcomes in these complex patients,” Patel said.

The updated statement, published online in Obesity Pillars, offers a variety of tools and checklists to aid clinicians, especially those who may not have access to a multidisciplinary team or dietitian knowledgeable about bariatric nutrition.

It is a follow-up to the OMA’s 2022 clinical practice statement, which provided an overview of bariatric surgery, gastrointestinal hormones, and the microbiome in patients with obesity.

 

Presurgical Guidance

The new guidance lays out the various components of preoperative nutrition screenings, among which is a medication review to determine if the patient is taking drugs that may affect weight and calorie intake. These include antihypertensives, diabetes agents, hormonal contraceptives, antidepressants, migraine medications, and antipsychotics.

In taking a patient’s history, clinicians should ask about major events associated with weight changes, such as medication changes, illness, pregnancy, divorce, stressful employment, food insecurity, and periods of disordered eating.

The fundamental approach to conducting a nutrition assessment is an understanding of the role that various sections of the gastrointestinal tract play in micronutrient absorption, the authors wrote. As an educational tool, the update includes a diagram that indicates the areas of the stomach, duodenum, jejunum, and ileum that may be altered by bariatric surgery and how they factor into micronutrient absorption.

“It makes it easier to see why certain surgical procedures are more likely to cause certain deficiencies,” Patel said.

 

Postsurgery Patient Management

Post surgery, clinicians should monitor patients for other problems that could affect nutrient absorption, including food intolerances, drug-nutrient interactions, and increased gastrointestinal transit time.

Patel and coauthors discussed the pros and cons of multivitamin mineral supplement formulations as well as specific vitamin and mineral recommendations for patients undergoing certain metabolic or bariatric surgery procedures. They included three supplemental cases in the appendix to illustrate supplementation recommendations and long-term maintenance suggestions.

“It’s important to remember that most of these deficiencies present without many clinical symptoms, so it becomes essential to screen for them and repeat as needed,” Patel said.

The update also tackles postoperative nutritional assessments and diet progression. No evidence supports following one postsurgical diet progression protocol over another, but they generally proceed from a clear liquid diet to foods with normal textures, the authors noted. Clinicians should adapt them according to the procedure type, they added.

In addition, clinicians must troubleshoot any nutrition-related concerns, including constipation, dehydration, nausea, heartburn, and fatigue, for up to a year after surgery, they wrote.

Metabolic and bariatric surgery patients should be evaluated annually at a minimum, if not more frequently, to gauge nutritional health, the authors wrote. Treating obesity as a disease involves more than weight loss — instead, it’s about improving the quality of life of patients through procedures, medications, and lifestyle modifications, they added.

 

Track New Developments

With ongoing changes in the field of metabolic and bariatric surgery, it’s helpful for clinicians to remain updated about new approaches across various disciplines linked to obesity management and treatment, said Christina Poa-Li, MD, a surgeon at Huntington Health Medical Center, affiliated with Cedars-Sinai Health System, in Pasadena, California, who was not involved in developing the updated practice statement.

“For example, the rapidly growing prescription of anti-obesity medications and their use in both preoperative and postoperative surgical patients drastically affect their nutrition,” she said. “Providers of various backgrounds and specialties will benefit from the most updated guidance on evaluating patient nutrition.”

Clinicians should consider expanding their patient population to include those with metabolic dysfunction–associated steatohepatitis or metabolic dysfunction–associated steatotic liver disease, Poa-Li said.

“These patient subpopulations may not have been considered for bariatric surgery or even referral to a bariatric surgeon for consultation previously,” she said. “It is important to increase awareness among clinicians of the potential benefits for metabolic and bariatric surgery for these patients.”

The report didn’t receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Patel and Poa-Li reported no relevant disclosures.

A version of this article appeared on Medscape.com.

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How Many Patients in Early Cancer Trials Get Drugs Ultimately Approved by FDA?

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TOPLINE:

One in six patients in phase 2 cancer trials received treatments that were eventually approved by the Food and Drug Administration (FDA), a new analysis found. This proportion increased to 1 in 5 when considering National Comprehensive Cancer Network (NCCN) off-label recommendations and decreased to about 1 in 11 for approved regimens considered to have a substantial clinical benefit.

METHODOLOGY:

  • Patients enroll in phase 2 oncology trials seeking access to promising new treatments, but the risk-benefit assessments and the likelihood of receiving a therapy that ultimately gains FDA approval remain unclear. Previous research suggests that the odds are 1 in 83 patients for those enrolled in a phase 1 cancer trial.
  • Researchers randomly selected 400 phase 2 cancer trials initiated between November 2012 and November 2015 (to give enough time for an approval to occur); these trials included more than 25,000 patients across 608 specific treatment cohorts testing 332 drugs.
  • The primary endpoint was the proportion of patients enrolled in phase 2 trials who received a treatment regimen that later attained FDA approval — defined as the “therapeutic proportion.”
  • A secondary endpoint was determining the therapeutic proportion based on the therapeutic value of drugs. The three benchmarks were FDA approval alone, FDA approval plus NCCN off-label recommendations, and FDA approval for drugs considered to have a substantial clinical benefit, based on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS).

TAKEAWAY:

  • A total of 4045 patients received a treatment regimen that advanced to FDA approval, corresponding to a therapeutic proportion of 16.2%.
  • The therapeutic proportion increased to 19.4% when considering NCCN off-label recommendations and decreased to 9.3% for FDA-approved regimens considered to have a substantial clinical benefit, based on the ESMO-MCBS.
  • The proportion of patients who participated in a trial in which the drug-indication pairing went on to phase 3 testing was 32.5%.
  • Enrollment in a trial featuring biomarker enrichment, an immunotherapy drug, a large phase 2 cohort, and a nonrandomized, industry-sponsored trial all showed a trend toward a higher therapeutic proportion.

IN PRACTICE:

“By entering a phase 2 trial, a patient has a one in six chance of receiving a treatment that will later be approved for their condition,” the authors wrote. “The proportions described here, when juxtaposed with those estimated previously for phase 1 trials, suggest a striking improvement for a patient’s therapeutic prospects. This suggests that phase 1 trials do a good job at protecting patients downstream from unsafe and ineffective cancer treatments.”

In an editorial accompanying the study, Howard S. Hochster, MD, of the Rutgers Cancer Institute in New Brunswick, New Jersey, suggested that the 16.2% therapeutic proportion reported may be understated. For instance, “if using the criterion of drugs that were FDA approved in any indication and dose, the proportion of patient benefit in these trials rises to 38%, with a 51% benefit rate considering inclusion in NCCN guidelines,” he wrote.

 

SOURCE:

This study, led by Charlotte Ouimet, MSc, Department of Equity, Ethics and Policy, McGill University School of Population and Global Health, Montréal, Québec, Canada, was published online in Journal of the National Cancer Institute.

LIMITATIONS:

The longitudinal design of this study required using a historical cohort of phase 2 clinical trials, which may not reflect current drug development patterns. This study was underpowered to determine trial characteristics that predicted higher therapeutic proportions. Furthermore, the exclusion of cytotoxic drugs from the analysis resulted in a somewhat restricted view of overall drug development.

DISCLOSURES:

This study was supported by the Canadian Institutes of Health Research. The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

One in six patients in phase 2 cancer trials received treatments that were eventually approved by the Food and Drug Administration (FDA), a new analysis found. This proportion increased to 1 in 5 when considering National Comprehensive Cancer Network (NCCN) off-label recommendations and decreased to about 1 in 11 for approved regimens considered to have a substantial clinical benefit.

METHODOLOGY:

  • Patients enroll in phase 2 oncology trials seeking access to promising new treatments, but the risk-benefit assessments and the likelihood of receiving a therapy that ultimately gains FDA approval remain unclear. Previous research suggests that the odds are 1 in 83 patients for those enrolled in a phase 1 cancer trial.
  • Researchers randomly selected 400 phase 2 cancer trials initiated between November 2012 and November 2015 (to give enough time for an approval to occur); these trials included more than 25,000 patients across 608 specific treatment cohorts testing 332 drugs.
  • The primary endpoint was the proportion of patients enrolled in phase 2 trials who received a treatment regimen that later attained FDA approval — defined as the “therapeutic proportion.”
  • A secondary endpoint was determining the therapeutic proportion based on the therapeutic value of drugs. The three benchmarks were FDA approval alone, FDA approval plus NCCN off-label recommendations, and FDA approval for drugs considered to have a substantial clinical benefit, based on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS).

TAKEAWAY:

  • A total of 4045 patients received a treatment regimen that advanced to FDA approval, corresponding to a therapeutic proportion of 16.2%.
  • The therapeutic proportion increased to 19.4% when considering NCCN off-label recommendations and decreased to 9.3% for FDA-approved regimens considered to have a substantial clinical benefit, based on the ESMO-MCBS.
  • The proportion of patients who participated in a trial in which the drug-indication pairing went on to phase 3 testing was 32.5%.
  • Enrollment in a trial featuring biomarker enrichment, an immunotherapy drug, a large phase 2 cohort, and a nonrandomized, industry-sponsored trial all showed a trend toward a higher therapeutic proportion.

IN PRACTICE:

“By entering a phase 2 trial, a patient has a one in six chance of receiving a treatment that will later be approved for their condition,” the authors wrote. “The proportions described here, when juxtaposed with those estimated previously for phase 1 trials, suggest a striking improvement for a patient’s therapeutic prospects. This suggests that phase 1 trials do a good job at protecting patients downstream from unsafe and ineffective cancer treatments.”

In an editorial accompanying the study, Howard S. Hochster, MD, of the Rutgers Cancer Institute in New Brunswick, New Jersey, suggested that the 16.2% therapeutic proportion reported may be understated. For instance, “if using the criterion of drugs that were FDA approved in any indication and dose, the proportion of patient benefit in these trials rises to 38%, with a 51% benefit rate considering inclusion in NCCN guidelines,” he wrote.

 

SOURCE:

This study, led by Charlotte Ouimet, MSc, Department of Equity, Ethics and Policy, McGill University School of Population and Global Health, Montréal, Québec, Canada, was published online in Journal of the National Cancer Institute.

LIMITATIONS:

The longitudinal design of this study required using a historical cohort of phase 2 clinical trials, which may not reflect current drug development patterns. This study was underpowered to determine trial characteristics that predicted higher therapeutic proportions. Furthermore, the exclusion of cytotoxic drugs from the analysis resulted in a somewhat restricted view of overall drug development.

DISCLOSURES:

This study was supported by the Canadian Institutes of Health Research. The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

One in six patients in phase 2 cancer trials received treatments that were eventually approved by the Food and Drug Administration (FDA), a new analysis found. This proportion increased to 1 in 5 when considering National Comprehensive Cancer Network (NCCN) off-label recommendations and decreased to about 1 in 11 for approved regimens considered to have a substantial clinical benefit.

METHODOLOGY:

  • Patients enroll in phase 2 oncology trials seeking access to promising new treatments, but the risk-benefit assessments and the likelihood of receiving a therapy that ultimately gains FDA approval remain unclear. Previous research suggests that the odds are 1 in 83 patients for those enrolled in a phase 1 cancer trial.
  • Researchers randomly selected 400 phase 2 cancer trials initiated between November 2012 and November 2015 (to give enough time for an approval to occur); these trials included more than 25,000 patients across 608 specific treatment cohorts testing 332 drugs.
  • The primary endpoint was the proportion of patients enrolled in phase 2 trials who received a treatment regimen that later attained FDA approval — defined as the “therapeutic proportion.”
  • A secondary endpoint was determining the therapeutic proportion based on the therapeutic value of drugs. The three benchmarks were FDA approval alone, FDA approval plus NCCN off-label recommendations, and FDA approval for drugs considered to have a substantial clinical benefit, based on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS).

TAKEAWAY:

  • A total of 4045 patients received a treatment regimen that advanced to FDA approval, corresponding to a therapeutic proportion of 16.2%.
  • The therapeutic proportion increased to 19.4% when considering NCCN off-label recommendations and decreased to 9.3% for FDA-approved regimens considered to have a substantial clinical benefit, based on the ESMO-MCBS.
  • The proportion of patients who participated in a trial in which the drug-indication pairing went on to phase 3 testing was 32.5%.
  • Enrollment in a trial featuring biomarker enrichment, an immunotherapy drug, a large phase 2 cohort, and a nonrandomized, industry-sponsored trial all showed a trend toward a higher therapeutic proportion.

IN PRACTICE:

“By entering a phase 2 trial, a patient has a one in six chance of receiving a treatment that will later be approved for their condition,” the authors wrote. “The proportions described here, when juxtaposed with those estimated previously for phase 1 trials, suggest a striking improvement for a patient’s therapeutic prospects. This suggests that phase 1 trials do a good job at protecting patients downstream from unsafe and ineffective cancer treatments.”

In an editorial accompanying the study, Howard S. Hochster, MD, of the Rutgers Cancer Institute in New Brunswick, New Jersey, suggested that the 16.2% therapeutic proportion reported may be understated. For instance, “if using the criterion of drugs that were FDA approved in any indication and dose, the proportion of patient benefit in these trials rises to 38%, with a 51% benefit rate considering inclusion in NCCN guidelines,” he wrote.

 

SOURCE:

This study, led by Charlotte Ouimet, MSc, Department of Equity, Ethics and Policy, McGill University School of Population and Global Health, Montréal, Québec, Canada, was published online in Journal of the National Cancer Institute.

LIMITATIONS:

The longitudinal design of this study required using a historical cohort of phase 2 clinical trials, which may not reflect current drug development patterns. This study was underpowered to determine trial characteristics that predicted higher therapeutic proportions. Furthermore, the exclusion of cytotoxic drugs from the analysis resulted in a somewhat restricted view of overall drug development.

DISCLOSURES:

This study was supported by the Canadian Institutes of Health Research. The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Bariatric Surgery Lowers Risk for Long-Term Liver Complications in MASH-Related Cirrhosis

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Among patients with obesity and compensated cirrhosis, bariatric surgery may significantly lower the risk of developing serious liver disease complications, according to a recent study by Cleveland Clinic researchers.

Compared with patients who received medical therapy alone, those who underwent bariatric surgery had a 72% lower risk of developing serious complications of liver disease and an 80% lower risk for progression to decompensated cirrhosis.

The results could have major implications for patients with metabolic dysfunction–associated steatohepatitis (MASH), particularly given that about 20% of patients with MASH progress to cirrhosis, the researchers said.

 

Dr. Steven Nissen

“Currently, lifestyle intervention is the only therapeutic recommendation for compensated MASH-related cirrhosis,” said Steven Nissen, MD, the senior author and chief academic officer of the Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Ohio.

“However, lifestyle changes alone rarely provide the weight loss and metabolic changes needed to reduce the risk of liver complications in this patient population,” he said. “This study shows that bariatric surgery is an effective treatment that can influence the trajectory of cirrhosis progression in select patients.”

The study was published online in Nature Medicine.

 

Significantly Reduced Risks

As part of the Surgical Procedures Eliminate Compensated Cirrhosis in Advancing Long-Term (SPECCIAL) observational study, Nissen and colleagues compared the long-term effects of metabolic surgery and medical treatment in patients with obesity and compensated, biopsy-proven MASH-related cirrhosis. They looked for six major adverse liver outcomes (MALO): ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, liver transplantation, and all-cause mortality.

Among nearly 37,000 patients who underwent liver biopsy at the Cleveland Clinic Health System between 1995 and 2020, the research team identified 168 patients (69.6% women) with MASH-related cirrhosis, Child-Pugh class A, and model for end-stage liver disease scores ≤ 10. Among those, 62 underwent metabolic surgery (37 Roux-en-Y gastric bypass and 25 sleeve gastrectomy) and 106 had nonsurgical treatment.

After overlap weighting, the groups had balanced baseline characteristics, including mean body mass index of 42.7, Fibrosis-4 score of 2.1, albumin of 4.1 g/dL, bilirubin of 0.6 mg/dL, and Elixhauser comorbidity index of 9. In each group, 84.5% had type 2 diabetes and 79.1% had Ishak fibrosis stage 6.

Overall, the 15-year cumulative incidence of MALO was 20.9% in the surgical group and 46.4% in the nonsurgical group (adjusted hazard ratio [aHR], 0.28; P = .003), with MALO occurring in 10 surgical patients and 42 nonsurgical patients.

Assuming a causal effect, the number needed to treat with metabolic surgery to avoid one incidence of MALO over a 15-year timespan was 4.5. 

The 15-year incidence of MALO was similar between surgical methods, with 20.1% for Roux-en-Y gastric bypass and 19.9% for sleeve gastrectomy.

In addition, the 15-year cumulative incidence of progression to decompensated cirrhosis was 15.6% in the surgical group and 30.7% in the nonsurgical group (aHR, 0.2; P = .01), with decompensation occurring in four surgical patients and 33 nonsurgical patients.

At 15 years, patients in the surgical group lost 31.6 kg or about 26.6% of their weight, and those in the nonsurgical group lost 10.7 kg or 9.8%.

Among patients with type 2 diabetes at baseline, metabolic surgery was associated with a reduction in hemoglobin A1c levels, as well as diabetes remission for some patients.

 

Potential to Fill an Unmet Need

Previous studies have indicated that bariatric surgery can effectively treat noncirrhotic MASH and lead to histologic resolution of MASH. In a 2021 study, Nissen and colleagues found bariatric surgery was associated with a lower risk for MALO and major adverse cardiovascular events in patients with biopsy-proven MASH without cirrhosis. Now, Nissen said, the SPECCIAL study indicates surgery may be a good option for MASH-related cirrhosis as well.

The study authors also noted that similar findings are theoretically possible from medical therapies, given the emergence of a new generation of anti-obesity medications. In this study, 16.8% of the surgical group and 14.3% of the nonsurgical group took semaglutide or tirzepatide at some point during the follow-up period.

“Patients with MASH-related cirrhosis have extremely limited treatment options,” said Sobia Laique, MD, study coauthor and a transplant hepatologist at the Cleveland Clinic who specializes in MASH-related cirrhosis. She cofounded the Cleveland Clinic’s task force on metabolic dysfunction–associated steatotic liver disease (MASLD) to improve screening, management, and patient outcomes for MASLD and related comorbidities.

“No therapeutic interventions have demonstrated efficacy in mitigating the risk of severe liver complications for these patients,” she said. “This underscores a critical unmet need for the development of effective therapies specifically targeting patients with compensated MASH-related cirrhosis.”

No funding was reported for this study. Several authors reported receiving grant funding, consultant fees, and advisory roles for various pharmaceutical companies.

A version of this article appeared on Medscape.com.

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Among patients with obesity and compensated cirrhosis, bariatric surgery may significantly lower the risk of developing serious liver disease complications, according to a recent study by Cleveland Clinic researchers.

Compared with patients who received medical therapy alone, those who underwent bariatric surgery had a 72% lower risk of developing serious complications of liver disease and an 80% lower risk for progression to decompensated cirrhosis.

The results could have major implications for patients with metabolic dysfunction–associated steatohepatitis (MASH), particularly given that about 20% of patients with MASH progress to cirrhosis, the researchers said.

 

Dr. Steven Nissen

“Currently, lifestyle intervention is the only therapeutic recommendation for compensated MASH-related cirrhosis,” said Steven Nissen, MD, the senior author and chief academic officer of the Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Ohio.

“However, lifestyle changes alone rarely provide the weight loss and metabolic changes needed to reduce the risk of liver complications in this patient population,” he said. “This study shows that bariatric surgery is an effective treatment that can influence the trajectory of cirrhosis progression in select patients.”

The study was published online in Nature Medicine.

 

Significantly Reduced Risks

As part of the Surgical Procedures Eliminate Compensated Cirrhosis in Advancing Long-Term (SPECCIAL) observational study, Nissen and colleagues compared the long-term effects of metabolic surgery and medical treatment in patients with obesity and compensated, biopsy-proven MASH-related cirrhosis. They looked for six major adverse liver outcomes (MALO): ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, liver transplantation, and all-cause mortality.

Among nearly 37,000 patients who underwent liver biopsy at the Cleveland Clinic Health System between 1995 and 2020, the research team identified 168 patients (69.6% women) with MASH-related cirrhosis, Child-Pugh class A, and model for end-stage liver disease scores ≤ 10. Among those, 62 underwent metabolic surgery (37 Roux-en-Y gastric bypass and 25 sleeve gastrectomy) and 106 had nonsurgical treatment.

After overlap weighting, the groups had balanced baseline characteristics, including mean body mass index of 42.7, Fibrosis-4 score of 2.1, albumin of 4.1 g/dL, bilirubin of 0.6 mg/dL, and Elixhauser comorbidity index of 9. In each group, 84.5% had type 2 diabetes and 79.1% had Ishak fibrosis stage 6.

Overall, the 15-year cumulative incidence of MALO was 20.9% in the surgical group and 46.4% in the nonsurgical group (adjusted hazard ratio [aHR], 0.28; P = .003), with MALO occurring in 10 surgical patients and 42 nonsurgical patients.

Assuming a causal effect, the number needed to treat with metabolic surgery to avoid one incidence of MALO over a 15-year timespan was 4.5. 

The 15-year incidence of MALO was similar between surgical methods, with 20.1% for Roux-en-Y gastric bypass and 19.9% for sleeve gastrectomy.

In addition, the 15-year cumulative incidence of progression to decompensated cirrhosis was 15.6% in the surgical group and 30.7% in the nonsurgical group (aHR, 0.2; P = .01), with decompensation occurring in four surgical patients and 33 nonsurgical patients.

At 15 years, patients in the surgical group lost 31.6 kg or about 26.6% of their weight, and those in the nonsurgical group lost 10.7 kg or 9.8%.

Among patients with type 2 diabetes at baseline, metabolic surgery was associated with a reduction in hemoglobin A1c levels, as well as diabetes remission for some patients.

 

Potential to Fill an Unmet Need

Previous studies have indicated that bariatric surgery can effectively treat noncirrhotic MASH and lead to histologic resolution of MASH. In a 2021 study, Nissen and colleagues found bariatric surgery was associated with a lower risk for MALO and major adverse cardiovascular events in patients with biopsy-proven MASH without cirrhosis. Now, Nissen said, the SPECCIAL study indicates surgery may be a good option for MASH-related cirrhosis as well.

The study authors also noted that similar findings are theoretically possible from medical therapies, given the emergence of a new generation of anti-obesity medications. In this study, 16.8% of the surgical group and 14.3% of the nonsurgical group took semaglutide or tirzepatide at some point during the follow-up period.

“Patients with MASH-related cirrhosis have extremely limited treatment options,” said Sobia Laique, MD, study coauthor and a transplant hepatologist at the Cleveland Clinic who specializes in MASH-related cirrhosis. She cofounded the Cleveland Clinic’s task force on metabolic dysfunction–associated steatotic liver disease (MASLD) to improve screening, management, and patient outcomes for MASLD and related comorbidities.

“No therapeutic interventions have demonstrated efficacy in mitigating the risk of severe liver complications for these patients,” she said. “This underscores a critical unmet need for the development of effective therapies specifically targeting patients with compensated MASH-related cirrhosis.”

No funding was reported for this study. Several authors reported receiving grant funding, consultant fees, and advisory roles for various pharmaceutical companies.

A version of this article appeared on Medscape.com.

Among patients with obesity and compensated cirrhosis, bariatric surgery may significantly lower the risk of developing serious liver disease complications, according to a recent study by Cleveland Clinic researchers.

Compared with patients who received medical therapy alone, those who underwent bariatric surgery had a 72% lower risk of developing serious complications of liver disease and an 80% lower risk for progression to decompensated cirrhosis.

The results could have major implications for patients with metabolic dysfunction–associated steatohepatitis (MASH), particularly given that about 20% of patients with MASH progress to cirrhosis, the researchers said.

 

Dr. Steven Nissen

“Currently, lifestyle intervention is the only therapeutic recommendation for compensated MASH-related cirrhosis,” said Steven Nissen, MD, the senior author and chief academic officer of the Miller Family Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Ohio.

“However, lifestyle changes alone rarely provide the weight loss and metabolic changes needed to reduce the risk of liver complications in this patient population,” he said. “This study shows that bariatric surgery is an effective treatment that can influence the trajectory of cirrhosis progression in select patients.”

The study was published online in Nature Medicine.

 

Significantly Reduced Risks

As part of the Surgical Procedures Eliminate Compensated Cirrhosis in Advancing Long-Term (SPECCIAL) observational study, Nissen and colleagues compared the long-term effects of metabolic surgery and medical treatment in patients with obesity and compensated, biopsy-proven MASH-related cirrhosis. They looked for six major adverse liver outcomes (MALO): ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, liver transplantation, and all-cause mortality.

Among nearly 37,000 patients who underwent liver biopsy at the Cleveland Clinic Health System between 1995 and 2020, the research team identified 168 patients (69.6% women) with MASH-related cirrhosis, Child-Pugh class A, and model for end-stage liver disease scores ≤ 10. Among those, 62 underwent metabolic surgery (37 Roux-en-Y gastric bypass and 25 sleeve gastrectomy) and 106 had nonsurgical treatment.

After overlap weighting, the groups had balanced baseline characteristics, including mean body mass index of 42.7, Fibrosis-4 score of 2.1, albumin of 4.1 g/dL, bilirubin of 0.6 mg/dL, and Elixhauser comorbidity index of 9. In each group, 84.5% had type 2 diabetes and 79.1% had Ishak fibrosis stage 6.

Overall, the 15-year cumulative incidence of MALO was 20.9% in the surgical group and 46.4% in the nonsurgical group (adjusted hazard ratio [aHR], 0.28; P = .003), with MALO occurring in 10 surgical patients and 42 nonsurgical patients.

Assuming a causal effect, the number needed to treat with metabolic surgery to avoid one incidence of MALO over a 15-year timespan was 4.5. 

The 15-year incidence of MALO was similar between surgical methods, with 20.1% for Roux-en-Y gastric bypass and 19.9% for sleeve gastrectomy.

In addition, the 15-year cumulative incidence of progression to decompensated cirrhosis was 15.6% in the surgical group and 30.7% in the nonsurgical group (aHR, 0.2; P = .01), with decompensation occurring in four surgical patients and 33 nonsurgical patients.

At 15 years, patients in the surgical group lost 31.6 kg or about 26.6% of their weight, and those in the nonsurgical group lost 10.7 kg or 9.8%.

Among patients with type 2 diabetes at baseline, metabolic surgery was associated with a reduction in hemoglobin A1c levels, as well as diabetes remission for some patients.

 

Potential to Fill an Unmet Need

Previous studies have indicated that bariatric surgery can effectively treat noncirrhotic MASH and lead to histologic resolution of MASH. In a 2021 study, Nissen and colleagues found bariatric surgery was associated with a lower risk for MALO and major adverse cardiovascular events in patients with biopsy-proven MASH without cirrhosis. Now, Nissen said, the SPECCIAL study indicates surgery may be a good option for MASH-related cirrhosis as well.

The study authors also noted that similar findings are theoretically possible from medical therapies, given the emergence of a new generation of anti-obesity medications. In this study, 16.8% of the surgical group and 14.3% of the nonsurgical group took semaglutide or tirzepatide at some point during the follow-up period.

“Patients with MASH-related cirrhosis have extremely limited treatment options,” said Sobia Laique, MD, study coauthor and a transplant hepatologist at the Cleveland Clinic who specializes in MASH-related cirrhosis. She cofounded the Cleveland Clinic’s task force on metabolic dysfunction–associated steatotic liver disease (MASLD) to improve screening, management, and patient outcomes for MASLD and related comorbidities.

“No therapeutic interventions have demonstrated efficacy in mitigating the risk of severe liver complications for these patients,” she said. “This underscores a critical unmet need for the development of effective therapies specifically targeting patients with compensated MASH-related cirrhosis.”

No funding was reported for this study. Several authors reported receiving grant funding, consultant fees, and advisory roles for various pharmaceutical companies.

A version of this article appeared on Medscape.com.

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